PIEZOTOME

K060275 · Satelec · ELC · May 3, 2006 · Dental

Device Facts

• Record ID: K060275
• Device Name: PIEZOTOME
• Applicant: Satelec
• Product Code: ELC · Dental
• Decision Date: May 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Periodontics Endodontics Scaling Prosthesis

Device Story

Piezotome™ is an ultrasonic scaler for dental practitioners. Device uses piezoelectric ultrasound technology to generate mechanical microvibrations for scaling with minimal soft tissue trauma. Features two handpiece cord connectors allowing simultaneous connection of two handpieces. Operates in four utilization modes with pre-set ultrasound power settings (Green/Low, Yellow/Medium, Blue/High, Orange/Very high) and adjustable irrigation fluid flow rate. Practitioner controls device via keyboard and multi-function footswitch. Settings for irrigation flow and ultrasound power are monitored on a screen; device memorizes last settings for clinical consistency. Used in clinic settings for prophylaxis, periodontics, endodontics, and prosthesis procedures. Benefits include precise mechanical treatment and efficient removal of deposits or restorative materials.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasonic scaler utilizing piezoelectric technology. Features two handpiece connectors, keyboard interface, and multi-function footswitch. Provides four pre-set power modes (Low to Very High) and adjustable irrigation fluid flow. Includes screen for monitoring power and flow settings. Memory function for last settings. Class II device.

Indications for Use

Indicated for dental practitioners performing periodontics (root planing, periodontal pockets, furcations, implant maintenance), endodontics (canal preparation/cleaning/filling, gutta percha condensation, retro surgery), scaling/prophylaxis (interdental/subgingival treatment, stain removal), and prosthesis (inlay/onlay condensation, amalgam plugging, loosening bridges/crowns/posts).

Regulatory Classification

Identification

An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Predicate Devices

• Suprasson® P5 Newtron (K050895)

Submission Summary (Full Text)

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3 2006 MAY

K060275 (p. 1 of 2)

- 9. SMDA Summary of Safety and Effectiveness "510(k) Summary"
- A. Submitter Information SATELEC Z.I. du Phare, BP 30216 17, Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE

Telephone: [phone] Fax: [phone]

| Contact Person: | Steve Salesky |
|-----------------|------------------------------------------|
| | SATELEC |
| | c/o Acteon, Inc. |
| | 130 Gaither Drive, Suite 100 |
| | Mt. Laurel, NJ 08054 |
| | Telephone: [phone] Ext. 40 |
| | Fax: [phone] |
| | E-mail: [e-mail] |

Date Prepared: January 30, 2006

B. Device Identification

Common Usual Name: Ultrasonic scaler

Proprietary Name: Piezotome™

C. Identification of Predicate Device

| Device | Applicant | 510(k) No. | Date Cleared |
|-----------------------|-----------|------------|----------------|
| Suprasson® P5 Newtron | Satelec | K050895 | April 20, 2005 |

The Satelec Piezotome™ is substantially equivalent to the predicate device by Satelec, the Suprasson® P5 Newtron (K050895) previously cleared by the FDA and currently marketed.

#### D. Device Description

The Piezotome™ is an ultrasonic scaler for use by dental practitioners.

The Piezotome™ device uses piezoelectric ultrasound technology to generate mechanical microvibrations for ultrasonic scaling, with minimal trauma to soft tissue.

In Newtron® function, it can be used for mechanical ultrasound treatment in prophylaxis, periodontics, endodontics or prosthesis.

This device is fitted with two handpiece cord connectors. Depending on the

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application, the practitioner may connect two handpieces at the same time.

The Piezotome™ function offers four utilization modes at pre-set ultrasound power settings. In Newtron® function, the power of the ultrasound can be finely adjusted by the user.

| Range | Ultrasound power | Procedure |
|--------|------------------|------------------------------------------------|
| Green | Low | Periodontics mainly |
| Yellow | Medium | Endodontics mainly |
| Blue | High | Prophylaxis mainly |
| Orange | Very high | Prosthesis or Specific<br>treatment modalities |

The user regulates the flow rate of the irrigation fluid.

The practitioner controls the device using a keyboard and a multi-function footswitch.

The irrigation fluid flow rate and the ultrasound power are monitored on a screen. For enhanced efficacy, the last settings are memorized by the machine.

#### E. Substantial Equivalence

The Piezotome™ and the predicate device, Suprasson® P5 Newtron (K050895) are both ultrasonic scalers for use in conventional dentistry by trained dental practitioners. Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the Piezotome™.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

MAY 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SATELEC C/O Mr. Steve Salesky Regulatory Affairs Acteon, Incorporated 130 Gaither Drive, Suite 100 Mount Laurel, New Jersey 08054

Re: K060275

Trade/Device Name: Piezotome™ Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: January 30, 2006 Received: February 2, 2006

Dear Mr. Salesky:

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 such 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. Steve Salesky

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Carls

Chiu Lin, Ph.D. 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

510(k) Number:

<060275

Device Name:

Piezotome™

Indications for Use:

Periodontics Endodontics Scaling Prosthesis

Please refer to the attached listing for a detailed description.

Prescription Use X (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)

Kein Mulvey for MSP

i)
Anesthesiology, General Hospital,
Control, Dental Devices

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K060275

## INDICATIONS FOR USE Piezotome™

### Periodontics:

- Root planing .
- Initial therapy .
- Treatment of periodontal pockets .
- Treatment of furcations .
- Maintenance therapy .
- Implant maintenance �

## Endodontics:

- Canal preparation ●
- Canal cleaning .
- Canal filling .
- Gutta percha condensation .
- Treatment resumption .
- Retro Surgery ●
- Micro Retro Surgery

Scaling (prophylaxis):

- Interdental junction treatment .
- Tooth neck and subgingival treatment .
- Treatment of large deposits .
- Treatment of coating and tobacco stains ●
- Interproximal treatment .

Prosthesis (conservative/restorative):

- . Inlay/onlay condensation
- ◆ Amalgam plugging
- Loosening prostheses (bridge, crown, post, pivot ... ) .

Susan Roarer

i And Hosistogy, General Hospital, in Connol. Dental Devices

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K066275