PIEZOTOME 2

K091331 · Satelec · DZI · Dec 11, 2009 · Dental

Device Facts

• Record ID: K091331
• Device Name: PIEZOTOME 2
• Applicant: Satelec
• Product Code: DZI · Dental
• Decision Date: Dec 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Satelec PIEZOTOME 2 is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.

Device Story

PIEZOTOME 2 is a dental operative unit serving as a base/utility supply for ultrasonic scalers and bone cutting instruments. Operated by qualified dental practitioners in clinical settings; device provides power and utilities to handpieces for surgical and restorative dental procedures. Output consists of ultrasonic energy delivered to dental tools to facilitate bone cutting or scaling. Device aids practitioners in performing periodontic, endodontic, and oral surgery tasks; benefits include precise bone cutting and scaling capabilities.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Dental operative unit; ultrasonic energy source for handpieces; supports scaling and bone cutting tools. No specific materials or software architecture details provided.

Indications for Use

Indicated for use by qualified dental practitioners for periodontics, endodontics, scaling, prosthesis, and oral surgery procedures requiring ultrasonic scaling or bone cutting instruments.

Regulatory Classification

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.

Predicate Devices

• PIEZOTOME (K060274)

Submission Summary (Full Text)

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# Ko9133

### 510(k) Pre-Market Notification for Satelec PIEZOTOME 2

DEC 1 1 2009

#### SMDA Summary of Safety and Effectiveness – "510 (k) Summary" ത

- A. Submitter Information SATELEC - ACTEON Group 17, Avenue Gustave Eiffel BP 30216 33708 Merignac Cedex FRANCE
- S

Telephone: [phone] Fax: [phone]

Contact Person:

Rick Rosati SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Tel: [phone] Ext. 39 Fax: [phone] Email: rick rosati@us acteongroup.com

May 1st, 2009 Date Prepared:

- B. Device Identification
Common Usual Name: Bone cutting instrument and accessories

Proprietary Name: PIEZOTOME 2

C. Identification of the Predicate Device

| Device | Applicant | 510(k) No. | Date Cleared |
|-----------|-----------|------------|--------------|
| PIEZOTOME | Satelec | K060274 | May 1, 2006 |

The Satelec PIEZOTOME 2 is substantially equivalent to the predicate device by Satelec, the PIEZOTOME (K060274) previously cleared by the FDA and currently marketed.

Indications for Use: The intended use of the Satelec PIEZOTOME 2 is to D. supply utilities to and serve as a base for dental tools such as ultrasonic scaler,

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### 510(k) Pre-Market Notification for Satelec PIEZOTOME 2

bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.

### E. Device Description

The Satelec PIEZOTOME 2 is a dental operative unit that supplies utilities to and serves as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.

#### F Substantial Equivalence

The PIEZOTOME 2 and the predicate device, PIEZOTOME (K060274) are both dental operative units that supplies utilities to and serves as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery. Differences that exist between the devices relating to technical specification, performances and intended use are minor and do not affect the safety and effectiveness of the PIEZOTOME 2.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

### DEC 1 1 2009

SATELEC C/O Mr. Rick Rosati Quality Manager ACTEON. Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054

Re: K091331

Trade/Device Name: Piezotome 2 Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: November 23, 2009 Received: November 24, 2009

Dear Mr. Rosati:

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.

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.

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Page 2- Mr. Rosati

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Rh for

Ánthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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## Indications for Use

1691231 510(k) Number:

PIEZOTOME 2 Device Name:

Indications for Use:

The intended use of the Satelec PIEZOTOME 2 is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kei Marley for MSP

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091331