PROTEGE ULTRASONIC INSERT

K051776 · Discus Dental, Inc. · ELC · Jul 13, 2005 · Dental

Device Facts

• Record ID: K051776
• Device Name: PROTEGE ULTRASONIC INSERT
• Applicant: Discus Dental, Inc.
• Product Code: ELC · Dental
• Decision Date: Jul 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Protégé Ultrasonic Inserts, both 25KHz and 30KHz models, are intended to be used in the handpieces of any magnetostrictive ultrasonic scaler for dental cleaning and the removal of tenacious calculus deposits by application of an ultrasonic vibrating tip to the teeth.

Device Story

Protégé Ultrasonic Inserts are dental instruments designed for use with magnetostrictive ultrasonic scaler handpieces. The device consists of a vibrating tip that, when activated by the handpiece, delivers ultrasonic energy to the tooth surface. This mechanical vibration facilitates the removal of tenacious calculus deposits during dental cleaning procedures. The device is intended for use by dental professionals in a clinical setting. By effectively removing calculus, the device aids in maintaining periodontal health and oral hygiene.

Clinical Evidence

Bench testing only.

Technological Characteristics

Magnetostrictive ultrasonic insert; 25KHz and 30KHz models; compatible with standard magnetostrictive ultrasonic scaler handpieces; mechanical vibration principle.

Indications for Use

Indicated for dental cleaning and removal of tenacious calculus deposits in patients requiring professional dental hygiene; compatible with magnetostrictive ultrasonic scaler handpieces.

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 logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, wave-like shapes, possibly representing people or services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 3 2005

Discus Dental Incorporated C/O Mr. Alfredo J. Quattrone, Ph.D., DABT Responsible Third Party Official California Department of Health Services Food & Drug Branch P.O. Box 997 413 Sacramento, California 95899-7413

Re: K051776

Trade/Device Name: Protégé Ultrasonic Insert Devices Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: June 22, 2005 Received: July 1, 2005

Dear Dr. Quattrone:

We have reviewed your Section 510(k) premarket notification of intent to rnarket 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 - Dr. Quattrone

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,

Quen Sulion for
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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Discus Dental Protégé Ultrasound Inserts

K051776

510(k) Submission (rev'd)

## Indications for Use Statement V.

510(k) Number: K051776

Device Name: Protégé Ultrasonic Insert Devices

Intended Use

Protégé Ultrasonic Inserts, both 25KHz and 30KHz models, are intended to be used in the handpieces of any magnetostrictive ultrasonic scaler for dental cleaning and the removal of tenacious calculus deposits by application of an ultrasonic vibrating tip to the teeth.

Prescription Use __ XX Per 21 CFR Section 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert J. Betz, DDS for Dr. Susan Runner

OR

sthesiology, General Hospital, Division of Ancol, Dental Devices

510(k) Number: K051776

p.07/ rev'd