PROANGLE DISPOSABLE PROPHY ANGLE

K030603 · Pac-Dent International (Suzhou), Ltd. · EGS · Apr 14, 2003 · Dental

Device Facts

• Record ID: K030603
• Device Name: PROANGLE DISPOSABLE PROPHY ANGLE
• Applicant: Pac-Dent International (Suzhou), Ltd.
• Product Code: EGS · Dental
• Decision Date: Apr 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The intended use of the ProAngle™ disposable prophy angle is for polishing and cleaning teeth.

Device Story

ProAngle™ disposable prophy angle is a dental device used for polishing and cleaning tooth surfaces. It consists of a gear pair, a turning spindle, and a drive spindle. The device connects to a low-speed dental handpiece; the turning spindle holds a prophylaxis cup that performs the cleaning/polishing action. It is intended for use by dental professionals in a clinical setting. The device is disposable, intended to simplify the cleaning process and reduce cross-contamination risks associated with reusable prophy angles.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical device consisting of a gear pair, turning spindle, and drive spindle. Designed for attachment to standard low-speed dental handpieces. Disposable form factor.

Indications for Use

Indicated for polishing and cleaning the surface of teeth. Used by attaching to a low speed handpiece.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Predicate Devices

• Allpro, Inc., Disposable prophy angle

Submission Summary (Full Text)

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K030603

# Pac-I)ent International (Suzhou), Inc.

## 510(k) Summary of Safety and Effectiveness

#### Submitter:

Pac-Dent International (Suzhou), Inc. 1 25 Binhe Road, New District of Suzhou City, J angsu Province, P. R. China Phone: [phone] Fax: [phone] Contact Person: Xu Wang Fhone: 909-839-0888 F ax: 909-839-0881 I Date Summary Prepared: Feb.2003

### l)evice Name:

"rade Name: ProAngle™ disposable prophy angle Common Name: Disposable prophy angle ( Classification Name: Handpiece, contra and right angle attachment (Classification: Class I

#### Devices for Which Substantial Equivalence is Claimed:

Allpro,Inc., Disposable prophy angle

#### Device Description:

?roAngle™ disposable prophy angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth.

#### Intended Use of the Device:

The intended use of the ProAngle™ disposable prophy angle is for polishing and cleaning teeth.

#### Substantial Equivalence:

ProAngle™ disposable prophy angle is substantially equivalent to other legally marketed devices in the United States. ProAngle™ disposable

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prophy angles function in a same manner and have the same use as the disposable prophy angle designed by AllPro, Inc.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font. The text is arranged around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2003

Mr. Xu Wang General Manager Pac-Dent International (Suzhou) Limited 125 Binhe Road, New District of Suzhou City, Jiangsu Province, P.R. CHINA

Re: K030603

Trade/Device Name: ProAngle™ Disposable Prophy Angle Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: February 18, 2003 Received: February 25, 2003

#### Dear Mr. Wang:

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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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.

Super Runner

Susan Runner, DDS, MA Interim 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 statement

Applicant: Pac-Dent International (Suzhou), Ltd.

510(k) Number no 30603

C evice Name: ProAngle™ disposable prophy angle

## Indications For Use:

F roAngle™ disposable prophy angle is a device intended to polish and clean t 1e surface of teeth. It should be attached to a low speed handpiece for operation.

Kein Mulkey for MSM
(Division Sign-Off)

n of Anesthesiolog General Hospital. Infection Control, Denta

510(k) Number: K 030603