Satelec - Acteon Group April 3, 2018

Argie Zoubroulis
Quality Manager
124 Gaither Drive Suite # 140
Mt. Laurel, New Jersey 08054

Re: K172137
Trade/Device Name: PIEZOTOME CUBE
Regulation Number: 21 CFR 872.4120
Regulation Name: Bone Cutting Instrument and Accessories
Regulatory Class: Class II
Product Code: DZI
Dated: March 23, 2018
Received: April 3, 2018

Dear Argie Zoubroulis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. The general controls provisions of the Act include requirements for annual
registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding
and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties.
We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.02.08
Silver Spring, MD 20993
www.fda.gov
Page 2 - Argie Zoubroulis K172137

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's
Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S
For Tina Kiang, Ph.D.
Acting Director
Division of Anesthesiology,
General Hospital, Respiratory,
Infection Control, and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2020
Indications for Use See PRA Statement below.

510(k) Number (if known)

K172137

Device Name
PIEZOTOME CUBE

Indications for Use (Describe)

The PIEZOTOME CUBE is an ultrasonic surgical system that supply utilities to and serve as a base for dental tips. The
PIEZOTOME CUBE consist of a control unit and handpiece intended for use in intraoral surgery procedures, including
osteotomy, osteoplasty, periodontics and implantology.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
006 – 510(k) Summary (SMDA Requirements)
S001_Additional Information
510(k) Summary
[As Required by 21 CFR 807.92.c]
K172137
I – SUBMITTER

01.a. 510(k) Submitter:

SATELEC
17, Avenue Gustave Eiffel
BP 30216
33708 Merignac Cedex
France
Telephone: 011-33-556-340-607
Fax: 011-33-556-349-292
email: philippe.girard@acteongroup.com

01.b. Contact Person:

Argie ZOUBROULIS
SATELEC
c/o ACTEON, Inc.
124 Gaither Drive, Suite 140
Mt. Laurel, NJ 08054
Telephone: 800-289-6367 Ext. 390
Fax: 856-222-4726
Email: argie.zoubroulis@acteongroup.com

1.c. Establishment Registration Number: 8044015

1.d. Date Prepared: May 2, 2018

1.e. Type of 510(k) submission: Traditional 510(k) Submission.

II – DEVICE

02.a. Trade Name of Device: PIEZOTOME CUBE

02.b. Common Name of Device: Piezoelectric Handpiece and Console

02.c. Classification Regulation: Classification Name : Bone Cutting Instrument

and Accessories (21 CFR 872.4120)

02.d. Regulation Identification: A bone cutting instrument and accessories is a

metal device intended for use in reconstructive
oral surgery to drill or cut into the upper or lower
jaw and may be used to prepare bone to insert
a wire, pin, or screw. The device includes the
manual bone drill and wire driver, powered bone
drill, rotary bone cutting Handpiece, and AC-
powered bone saw.

02.e. Medical Device Class: II

Pre-Market Notification 510(k) Submission File for PIEZOTOME CUBE By SATELEC

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006 – 510(k) Summary (SMDA Requirements)
S001_Additional Information
02.f. Panel: Dental

02.g. Product Code: DZI

02-h. Subsequent Product Codes: Not Applicable

III – PREDICATE DEVICES

The Substantial Equivalence (SE) of PIEZOTOME CUBE is based on the Predicate Device identified in
the Table 01.

Table 01 – Identification of Legally Marketed Predicate Devices

Trade Name Manufacturer Product Code 510(k) number Date Cleared

PIEZOTOME SOLO
SATELEC DZI K112188 Feb 03, 2012
PIEZOTOME SOLO LED

IV –DEVICE DESCRIPTION

SATELEC CUBE is an piezoelectric device that uses micro-vibrations of associated Tips, to perform the
dental procedures defined in Indication for Use.

PIEZOTOME CUBE consists of a Console, a Multifunction footswitch and a reusable Handpiece.

The Console is the heart of the SATELEC PIEZOTOME CUBE. The Console contains the display board
and the motherboard. Ultrasonic Handpiece and Footswitch are connected to the Console. The Touch
screen present on the front panel is used to define the settings of the SATELEC PIEZOTOME CUBE
(Ultrasonic modes, irrigation flow values).

The Ultrasonic Handpiece is held in the Practitioner’s hand. The Ultrasonic Handpiece is connected to
the Console via a Handpiece Cord. The Handpiece is dedicated to Dental Bone Surgery procedures.
The Ultrasonic Handpiece is equipped with a Piezoelectric Transducer. The Piezoelectric transducer
converts the Electrical Signal delivered by the Console into mechanical micro-vibrations. The Ultrasonic
Handpiece is reusable and Sterilizable by autoclaving.

Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpiece. Tip are in direct
contact to the patient. The ultrasonic mechanical vibrations are transmitted to the Tip.

The Pump housing is designed to accommodate SATELEC Irrigation Tubing cassettes. Irrigation
Tubings are Single Use and delivered under Sterile State. Irrigation Solution is intended to cool the
clinical site and rinse the fragments such as bone or teeth.

Pre-Market Notification 510(k) Submission File for PIEZOTOME CUBE By SATELEC

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006 – 510(k) Summary (SMDA Requirements)
S001_Additional Information
V – INDICATION FOR USE

The PIEZOTOME CUBE is an ultrasonic surgical system that supply utilities to and serve as a base for
dental tips. The PIEZOTOME CUBE consist of a control unit and handpiece intended for use in intraoral
surgery procedures, including osteotomy, osteoplasty, periodontics and implantology.

VI – COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

(SUBSTANTIAL EQUIVALENCE)

A comparison Between SATELEC PIEZOTOME CUBE and the Predicate Device is present in Table
02.

Table 02 – Comparison Between SATELEC PIEZOTOME CUBE and the Predicate Device

Predicate Device #1
New Device
(PD#1)
Impact of the differences
Trade /
PIEZOTOME CUBE PIEZOTOME SOLO on Safety /
Device Name
Effectiveness
Knumber K172137 K112188
The intended use of the
The PIEZOTOME CUBE SATELEC PIEZOTOME
is an ultrasonic surgical SOLO (or PIEZOTOME
system that supply SOLO LED available in
utilities to and serve as a option) is to supply
base for dental tips. The utilities to and serve as a
PIEZOTOME CUBE base for dental tools and
Indication for Use consist of a control unit accessories for use by Similar to PD#1 - No Impact
and handpiece intended qualified dental
for use in intraoral practitioners.
surgery procedures,
including osteotomy,
osteoplasty, periodontics
and implantology.
The intended use of the
The intended use of the PIEZOTOME SOLO is to
SATELEC PIEZOTOME supply utilities to and
CUBE is to supply utilities serve as a base for
and to serve as a base for dental tools and
Intended Use Similar to PD#1 - No Impact
dental tools and accessories for use by
accessories for use by qualified dental
qualified dental practitioners. The
practitioners. PIEZOTOME SOLO is a
device designed to
perform dental surgery
including osteotomies,
osteoplasties,
periodontal
and implant
surgery.

Code Product DZI DZI Identical to PD#1 - No Impact

Subsequent product
/ / Identical to PD#1 - No Impact
Codes
Part 872 - Dental devices 872 - Dental devices Identical to PD#1 - No Impact
Regulation Number 21 CFR 872.4120 21 CFR 872.4120 Identical to PD#1 - No Impact

Pre-Market Notification 510(k) Submission File for PIEZOTOME CUBE By SATELEC

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006 – 510(k) Summary (SMDA Requirements)
S001_Additional Information
A bone cutting instrument A bone cutting
and accessories is a instrument and
metal device intended for accessories is a metal
use in reconstructive oral device intended for use
Regulation Identification surgery to drill or cut into in reconstructive oral Identical to PD#1 - No Impact
the upper or lower jaw surgery to drill or cut into
and may be used to the upper or lower jaw
prepare bone to insert a and may be used to
wire, pin, or screw. The prepare bone to insert a

Pre-Market Notification 510(k) Submission File for PIEZOTOME CUBE By SATELEC

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006 – 510(k) Summary (SMDA Requirements)
S001_Additional Information
Predicate Device #1
New Device
(PD#1)
Impact of the differences on
Trade /
PIEZOTOME CUBE PIEZOTOME SOLO Safety / Effectiveness
Device Name
Knumber K172137 K112188
device includes the wire, pin, or screw. The
manual bone drill and device includes the
wire driver, powered manual bone drill and
bone drill, rotary bone wire driver, powered
cutting handpiece, and bone drill, rotary bone
AC-powered bone saw cutting handpiece, and
AC-powered bone saw
Bone Cutting Instrument Bone Cutting Instrument
Regulation Name Identical to PD#1 - No Impact
and Accessories and Accessories
Regulatory Class II II Identical to PD#1 - No Impact
Principle of operation
An electrical signal emitted by the medical device is
supplied to the dental piezo-ultrasonic Handpiece. It
comprises a piezoelectric ceramic transducer, which
Principle Identical to PD#1 - No Impact
converts the electrical signal into ultrasonic
vibrations. Mechanical vibrations are transmitted to a
tip attached to the end of the ultrasonic Handpiece
Dimensions of the Console
Height (mm) 160 136 No Impact
Depth (mm) 271 306 No Impact
Width (mm) 251 378 No Impact
Weight (kg) 3.5 3.7 No Impact
Mounting Unit Table Top Table Top Identical to PD#1 - No Impact
Power Supply
Supply Voltage (VAC) 100 VAC to 230 VAC 100 VAC to 230 VAC Identical to PD#1 - No Impact
Frequency (Hz) 50 Hz / 60 Hz 50 Hz / 60 Hz Identical to PD#1 - No Impact
Power Consumption (VA) 150 150 Identical to PD#1 - No Impact
Electrical Safety Classification
Equipment Classification Class 1 Class 1 Identical to PD#1 - No Impact
Electrical Type BF Type BF Type Identical to PD#1 - No Impact
Applied Parts on the Console
Quantity of connectors for
1 1 Identical to PD#1 - No Impact
Applied Parts
Front Panel of the Front Panel of the
Localization Identical to PD#1 - No Impact
Device Device
Internal constitution of the Console
Power supply Switch Power Supply Switch Power Supply Identical to PD#1 - No Impact
UL94-V0 (self- UL94-V0 (self-
Mother Board Fire aspects Identical to PD#1 - No Impact
extinguishing material) extinguishing material)
Display Board Fire UL94-V0 (self- UL94-V0 (self-
Identical to PD#1 - No Impact
aspects extinguishing material) extinguishing material)
External constitution of the Console
UL94-V0 (self- UL94-V0 (self-
Fire aspects (for Casing) Identical to PD#1 - No Impact
extinguishing material) extinguishing material)
Pictures

Picture of the Console No impact

Pre-Market Notification 510(k) Submission File for PIEZOTOME CUBE By SATELEC

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006 – 510(k) Summary (SMDA Requirements)
S001_Additional Information
Predicate Device #1
New Device
(PD#1)
Impact of the differences on
Trade /
PIEZOTOME CUBE PIEZOTOME SOLO Safety / Effectiveness
Device Name
Knumber K172137 K112188

Picture of the Footswitch Identical to PD#1 - No Impact

Piezoelectric Performances for Dental Bone Surgery

SATELEC PIEZOTOME SATELEC PIEZOTOME
Technology Identical to PD#1 - No Impact
topology topology
Output Ultrasonic
28 to 36 28 to 36 Identical to PD#1 - No Impact
frequency (kHz)
Available modes D1/ D2 / D3 / D4 D1/ D2 / D3 / D4 Identical to PD#1 - No Impact
Nominal specification for
Output Current Value in 215.3 215.3 Identical to PD#1 - No Impact
D1 mode (mA)
Nominal specification for
Output Current Value in 171.2 171.2 Identical to PD#1 - No Impact
D2 mode (mA)
Nominal specification for
Output Current Value in 123.9 123.9 Identical to PD#1 - No Impact
D3 mode (mA)
Nominal specification for
Output Current Value in 120.8 120.8 Identical to PD#1 - No Impact
D4 mode (mA)
Frequency Modulation for
60 60 Identical to PD#1 - No Impact
D1 mode (Hz)
Frequency Modulation for
60 60 Identical to PD#1 - No Impact
D2 mode (Hz)
Frequency Modulation for
60 60 Identical to PD#1 - No Impact
D3 mode (Hz)
Frequency Modulation for
30 30 Identical to PD#1 - No Impact
D4 mode (Hz)
Irrigation Performances
Irrigation Pump(s) 1 1 Identical to PD#1 - No Impact
Off Irrigation (ml/min) 0 0 Identical to PD#1 - No Impact
Minimum Irrigation Flow
10 10 Identical to PD#1 - No Impact
Rate (nominal) (ml/min)
Maximum Irrigation Flow
120 120 Identical to PD#1 - No Impact
Rate (nominal) (ml/min)
Localization of the Mains Power Switch
Mains switch localized at Mains switch localized
Power-On / Power-Off Identical to PD#1 - No Impact
the rear of the Device at the rear of the Device
User Interface for setting
User interface for LED (Light Emitted
Monochrome LCD No Impact
information on settings Diode)
Ultrasonic Power Setting Sensitive areas on front
Keys on front panel No Impact
keys panel
Irrigation Flow Setting Sensitive areas on front
Keys on front panel No Impact
keys panel
Footswitch
Type of Footswitch Multifunction Multifunction Identical to PD#1 - No Impact
Number of actuators on
2 Functions 2 Functions Identical to PD#1 - No Impact
Footswitch
Environmental

Pre-Market Notification 510(k) Submission File for PIEZOTOME CUBE By SATELEC

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006 – 510(k) Summary (SMDA Requirements)
S001_Additional Information
Predicate Device #1
New Device
(PD#1)
Impact of the differences on
Trade /
PIEZOTOME CUBE PIEZOTOME SOLO Safety / Effectiveness
Device Name
Knumber K172137 K112188
Usable in all medical Usable in all medical
premises premises
Where used Identical to PD#1 - No Impact
Except Operating Except Operating
theater / outdoor theater / outdoor
Operating Temperature
+10 to +30 +10 to +30 Identical to PD#1 - No Impact
(°C)
Storage Temperature (°C) 0 to +50 -20 to +70 No Impact
Maximum Operating
2000 2000 Identical to PD#1 - No Impact
Altitude (m)
Bones in the oral
Anatomical site Bones in the oral sphere Identical to PD#1 - No Impact
sphere
Handpieces
Dental Bone Surgery PIEZOTOME SOLO
CUBE LED Handpiece No Impact
Handpiece Handpiece
Type of Applied Part Ultrasonic Handpiece Ultrasonic Handpiece Identical to PD#1 - No Impact
Technology used for
Piezoelectric technology Piezoelectric technology Identical to PD#1 - No Impact
Handpieces
Dimensions of the Dental Bone Surgery Handpieces
Length (mm) 130 130 Identical to PD#1 - No Impact
Maximum Diameter (mm) 23 23 Identical to PD#1 - No Impact
Irrigation Tubing
Length (mm) 2550 2550 Identical to PD#1 - No Impact
Principle of irrigation Peristaltic tape Peristaltic tape Identical to PD#1 - No Impact
Dimensions of the Footswitch
Width (mm) 173 173 Identical to PD#1 - No Impact
Height (mm) 140 140 Identical to PD#1 - No Impact
Depth (mm) 176 176 Identical to PD#1 - No Impact
Ingress Protection Rating
IPX1 IPX1 Identical to PD#1 - No Impact
(IPxx)
Cleaning
Dental Bone Ultrasonic
Re-usable, Cleanable Re-usable, Cleanable Identical to PD#1 - No Impact
Handpiece
Unit Casing Re-usable, Cleanable Re-usable, Cleanable Identical to PD#1 - No Impact
Sterilization / Sterile State
Dental Bone Ultrasonic Sterilizable Sterilizable
Identical to PD#1 - No Impact
Handpiece 132°C / 4 min 132°C / 4 min
Provided under Sterile Provided under Sterile
Irrigation Tubing Identical to PD#1 - No Impact
State - Single Use State - Single Use
Biocompatibility
Ultrasonic Handpiece Polyphenylsulfone Polyphenylsulfone
material in contact to (PPSU) used in Medical (PPSU) used in Medical Identical to PD#1 - No Impact
Patient Application Application
Standards
Safety Standard IEC 60601-1 IEC 60601-1 Identical to PD#1 - No Impact
EMC Standard IEC 60601-1-2 IEC 60601-1-2 Identical to PD#1 - No Impact
Summary of Major Changes
Major Changes - User Interface for setting
Sensitive areas with
User interface for Setting Light Emitted Diode Monochrome LCD No Impact
(LED)
Accessible on Sensitive Accessible on Keyboard
Ultrasonic Power Setting No Impact
area on front panel on front panel

Pre-Market Notification 510(k) Submission File for PIEZOTOME CUBE By SATELEC

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S001_Additional Information
Predicate Device #1
New Device
(PD#1)
Impact of the differences on
Trade /
PIEZOTOME CUBE PIEZOTOME SOLO Safety / Effectiveness
Device Name
Knumber K172137 K112188
Accessible on Sensitive Accessible on Keyboard
Irrigation Flow Setting No Impact
area on front panel on front panel
Handpieces
Dental Bone Surgery PIEZOTOME SOLO
CUBE LED Handpiece
Handpiece Handpiece
No Impact
Pictures of Dental Bone
Surgery Handpieces

A lot of features and characteristics of PIEZOTOME CUBE are identical to the Predicate Device #1. The
Identified differences have no impact on the Substantial Equivalence. Moreover, the identified Major
Changes have no impact on the Substantial Equivalence.

VII – PERFORMANCE DATA

Electromagnetic Compatibility Test: The Electromagnetic Compatibility Tests have been performed
according to IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral standard:
Electromagnetic disturbances -- requirements and tests (Recognition Number 19-12).

IEC 60601-
Electrical Safety Tests: The Electrical Safety Tests have been performed according to
1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance (General). (Recognition Number 5-71) included USA and Canadian
Deviations.
Software Verification and Validation: Software Verification and Validation activities were conducted
and documented according to the document named “Guidance for Industry and FDA Staff - Guidance
for the Content of Premarket Submissions for Software Contained in Medical Devices” dated May 11,
2005.

Performance Testing bench: The comparison of performances between PIEZOTOME CUBE and
Predicate Device has been performed. The Technical Characteristics for PIEZOTOME CUBE
(Piezoelectric Performances, Frequency Modulations and Irrigation Performances) are similar as the
Predicate Device PIEZOTOME SOLO (K112188, cleared February 03, 2012).

Sterilization Validation: The Sterilizability Tests of SATELEC CUBE LED Handpiece have been
performed according to applicable Standards for Re-Usable accessories (i.e., ISO 17665-1, ISO
17665-2, AAMI ST55, and AAMI TIR 30).

Cleaning Validation: Cleaning validation of the PIEZOTOME CUBE was conducted per the
FDA Guidance Document entitled, “Reprocessing Medical Devices in Health Care Settings:
Validation Methods and Labeling” dated March 17, 2015.

Biocompatibility Validation: The Biocompatibility Tests have been performed according to applicable
Standards for Accessories in contact to the Patient. Tests were conducted according to the ISO 10993-
1 Standard and 510(k) Memorandum - #G95-1 Table 1 “Initial Evaluation Tests for Consideration

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S001_Additional Information
requirements (Body Contact: External communicating Device – Type of Tissues: Tissue / Bone Dentin
Communicating – Contact Duration: A limited less than 24 hours). SATELEC CUBE LED Handpiece is
the same as SATELEC PIEZOTOME SOLO Handpiece used with the Predicate Device PIEZOTOME
SOLO (K112188, cleared February 03, 2012).

VIII –CONCLUSION

Following all information contained in this Pre-Market Notification Submission File, we can declare that
the SATELEC PIEZOTOME CUBE is Substantially Equivalent (SE) to the SATELEC Predicate Device
PIEZOTOME SOLO (K112188, cleared February 03, 2012).

End of Section
(No other information after this line expect Appendix if applicable)

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