AIR SONIC SCALER

K083059 · Dpm USA Corp. · ELC · Jan 30, 2009 · Dental

Device Facts

• Record ID: K083059
• Device Name: AIR SONIC SCALER
• Applicant: Dpm USA Corp.
• Product Code: ELC · Dental
• Decision Date: Jan 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Air Schic Scaler is intended for use by dental professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits from teeth.

Device Story

Air-powered ultrasonic scaler; used by dental professionals for cleaning and periodontal therapy. Device utilizes air pressure to drive an ultrasonically vibrating tip at 6,000 Hz. Tip is constructed of 440A stainless steel and available in three shapes (AS1, AS2, AS3). Operates by applying mechanical vibration to teeth to remove calculus, tartar, and stains. Used in clinical dental settings.

Clinical Evidence

No clinical data provided; device relies on substantial equivalence to a predicate device.

Technological Characteristics

Air-powered ultrasonic scaler; 6,000 Hz vibration frequency; 440A stainless steel tips (AS1, AS2, AS3).

Indications for Use

Indicated for use by dental professionals for dental cleaning and periodontal therapy to remove calculus and tartar deposits from teeth.

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

• Lynx-SM Scaler Dental Handpiece (K901488)

Submission Summary (Full Text)

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K083059

JAN 3 0 2009

Image /page/0/Picture/1 description: The image shows the logo for DPM USA Dental Products Manufacture. The logo features the letters "DPM" in large, bold font, with a star on top of the "D" and "P". The words "USA Dental Products Manufacture" are written in a smaller font to the right of the letters. The word "CORP." is written on the bottom left of the logo.

October 9. 2008

Section III - 510(k)

# Summary of Safety and Effectiveness

Submitter:

DPM USA Corp. 1460 NW 107 Ave Suite G Miami, Florida 33172 Phone: [phone] Fax: [phone] Contact Person: George Echeverri

Summary Prepared Date: October 9, 2008

Device Name:

- 1. Trade Name- Air Sonic Scaler
- II. Common Name- Air-Powered Ultrasonic Scaler
- III. Classification Name- Ultrasonic Scaler
- IV. Classification Number: 21 CFR 872.4850
- V. Product Code: ELC

# Device for Which Substantial Equivalence is Claims:

- 1. Lynx-SM. Scaler Dental Handpiece
- 2. 510 (k) K901488
- 3. Manufacture: MTI Precision Products, Inc.

# Device Description / Intended Use:

The Air Sonic Scaler, is intended for use by medical professionals during cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a surgical 440A stainless steel tip, The tip comes in 3 different shapes (AS1, AS2, AS3) and is designed to generate a vibrating frequency of 6,000 Hz.

FDA CDRH DMC

JAN 2 7 2009

Received

K-37

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3.0 2009

Mr. George Echeverri Director DPM USA Corporation 1460 NW 107 Avenue, Suite G Miami, Florida 33172

Re: K083059

> Trade/Device Name: Air Sonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: October 9, 2008 Received: January 27, 2009

Dear Mr. Echeverri:

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. Echeverri

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html,

Sincerely yours,

Anthony D. Watson for
Ginette Y. Michaud, M.D.
Acting 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 (if know):

Device Name: Air Sonic Scaler

Indications for Use:

The intended use of the Air Schic Scaler is intended for use by dental professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits from teeth.

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

Over-The-Counter Use (21 CFR Part 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumer

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

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**510(k) Number.***_*_