USI DENTAL SCALER, 25XXX SERIES

K062791 · Ultrasonic Services, Inc. · ELC · Dec 11, 2006 · Dental

Device Facts

• Record ID: K062791
• Device Name: USI DENTAL SCALER, 25XXX SERIES
• Applicant: Ultrasonic Services, Inc.
• Product Code: ELC · Dental
• Decision Date: Dec 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to teeth.

Device Story

USI Dental Scaler 25XXX Series is an ultrasonic device used by dental professionals for cleaning and periodontal therapy. Device utilizes ultrasonic vibration applied via a scaler tip to remove calculus deposits from teeth. Operates in a clinical dental setting. Output is mechanical vibration for plaque and calculus removal. Benefits include efficient removal of dental deposits during routine hygiene or periodontal procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasonic scaler; utilizes ultrasonic vibration for calculus removal; intended for professional dental use; class II device (Product Code ELC).

Indications for Use

Indicated for dental cleaning and periodontal therapy to remove calculus deposits from teeth in patients requiring professional dental hygiene or periodontal treatment.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which is a stylized caduceus with three branches. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the logo. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2006

Mr. James Feine President Ultrasonic Services, Incorporated 7126 Mullins Drive Houston, Texas 77081

Re: K062791

Trade/Device Name: USI Dental Scaler, 25XXX Series Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: December 4, 2006 Received: December 7, 2006

Dear Mr. Feine:

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. Feine

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/industry/support/index.html.

Sincerely yours,

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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K062791

## Indications for Use

510(k) Number (if known): K062791

Device Name: USI Dental Scaler 25XXX Series

Indications for Use:

Dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to teeth.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Dunne

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