ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE

K023953 · St. George Technology, Inc. · EGS · Feb 14, 2003 · Dental

Device Facts

• Record ID: K023953
• Device Name: ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
• Applicant: St. George Technology, Inc.
• Product Code: EGS · Dental
• Decision Date: Feb 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The device is a plastic disposable attachment for use in conjunction with a slow speed handpiece, used during the professional prophylaxis treatment of patient's teeth by a dentist or hygienist.

Device Story

Plastic disposable prophy angle; housing holds two internal shafts at 90-degree angle; rotates rubber cup or brush tip. Used in dental offices/operatories by dentists or hygienists. Attaches to standard ISO-fitting slow-speed handpieces to provide rotational energy for tooth cleaning. Non-latex materials used for cups to mitigate allergy risks. Single-use device; discarded after each patient.

Clinical Evidence

Bench testing only. In-vitro testing performed for fit, wear, duration of performance, strength, and durability. Results demonstrated satisfactory performance compared to the predicate device.

Technological Characteristics

Plastic housing; two internal shafts at 90-degree angle; rubber cup or brush tip. Energy source: external slow-speed handpiece. Connectivity: ISO-fitting standard. Sterilization: non-sterile. Biocompatibility: non-latex materials.

Indications for Use

Indicated for use by dental professionals (dentists or hygienists) for the cleaning of a patient's teeth. Intended for single-patient use only.

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

• Young Dental Manufacturing Disposable Prophy Angle (790722)

Submission Summary (Full Text)

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Koz3953

11:40:00

### ST. GEORGE TECHNOLOGY, INC.

FEB 1 4 2003

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## I'remarket Notification [510(k)] Summary

| Submitted by: | St. George Technology, Inc. |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Vernon Watkins |
| Address: | P.O. Box 2849<br>Wilmington, NC 28402<br>USA |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Date Prepared: | November 2002 |
| Trade Name: | St. George Technology, Inc. Perfection Plus Disposable<br>Prophy Angles |
| Common Name: | Disposable Prophy Angles (DPA's) |
| Classification Name: | Dental Contra and Right-Angle Handpiece Attachment |
| Predicate Device: | Young Dental Manufacturing Disposable Prophy Angle |
| Description Of Device: | Plastic disposable item comprising a housing (body) that<br>holds two plastic shafts aligned at 90 degrees (right angle)<br>to each other that rotate a cup or brush. |
| Intended Use: | The device is a plastic disposable attachment for use in<br>conjunction with a slow speed handpiece, used during the<br>professional prophylaxis treatment of patient's teeth by a<br>dentist or hygienist. |

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# ST. GEORGE TECHNOLOGY, INC.

´ `echnological Characteristics Compared With Predicate Device:

| | Device 1 | St. George Technology |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| | Young Manufacturing DPA | Perfection Plus DPA |
| | 510(k) 790722 | |
| Indications for Use | For single use by Dental Professional in<br>cleaning patient's teeth. | Same |
| Target Population | Dentists and Hygienists | Same |
| Design | Plastic one-piece housing (outer body)<br>holding 2 internal shafts aligned at 90<br>degree (right angle) to each other. Tip<br>fitted with a rubber cup or brush to clean<br>teeth. | Same |
| Materials | Two types of plastic with either a rubber<br>cup or brush fitted at the cleaning tip. | Same |
| Performance | To be able to perform a full cleaning<br>procedure. | Same |
| Sterility | Non Sterile | Same |
| Biocompatibility | Have caused concern with latex allergies<br>due to cup material. | Non latex material used on all<br>cups - Improvement |
| Mechanical Safety | Robust construction to withstand forces<br>involved in a cleaning. | Same |
| Energy<br>Used/Delivered | Rotation of the cleaning device cup/brush<br>tip provided by a slow speed hand piece | Same |
| Compatibility with<br>other devices | Designed to fit securely onto most<br>available ISO fitting standard slow speed<br>hand pieces | Same |
| Where Used | Dental Office/Operatory | Same |

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#### ST. GEORGE TECHNOLOGY, INC.

↑ Ion-Clinical Performance:

The St. George Technology, Inc. Perfection Plus Disposable Prophy Angles have been extensively tested in in-vitro environments for fit, wear, duration of performance, strength, and durability.

Conclusion From l Non Clinical Test:

In all criteria the St. George Technology, Inc. Perfection Plus Disposable Prophy Angle performed satisfactorily when compared to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2003

Mr. Vernon Watkins President St. George Technology, Incorporated P.O. Box 2849 Wilmington, North Carolina 28402-2849

Re: K023953

Trade/Device Name: St. George Technology, Inc. Perfection Plus Disposable Prophy Angles Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: November 26, 2002 Received: November 27, 2002

Dear Mr. Watkins:

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. Watkins

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,

Susan Kunner

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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ST. GEORGE TECHNOLOGY, INC.

K023553

## Statement of Indications for Use

()ur disposable prophylaxis angle is intended as a single use device used by : Dental Professional, either a Dentist or a Dental Hygienist to assist in the cleaning process of patient's teeth. It is intended for a single patient and :hould be discarded after each patient.

Ken Muly for nsn

(Division Sign-C v. General Hospital. Division of Anesthesiology Infection Control, Dental I

510(k) Number. K023953