PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM

K974655 · Prep Technology Corp. · KOJ · Jul 9, 1998 · Dental

Device Facts

• Record ID: K974655
• Device Name: PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM
• Applicant: Prep Technology Corp.
• Product Code: KOJ · Dental
• Decision Date: Jul 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Prep Technology Corp. PrepTech 200TM Cavity Preparation System is intended for use in cavity preparation for bonded restorations, the removal of decayed or sound tooth structure and composite restoration materials and for the preparation of tooth surfaces prior to pit and fissure sealant and composite restorations.

Device Story

Air abrasive system for dental applications; utilizes pressurized air and aluminum oxide powder to generate high-velocity kinetic particle stream. Used by dental professionals for cavity preparation, removal of decay/restorative materials, and surface preparation for sealants/composites. Device functions via mechanical abrasion; no electronic or software-based processing. Clinical benefit includes efficient tooth structure removal for restorative procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Air abrasive system; utilizes pressurized air and aluminum oxide powder. Mechanical principle of operation. Classified as an airbrush (21 CFR 872.6080).

Indications for Use

Indicated for dental cavity preparation, removal of decayed or sound tooth structure, removal of composite restoration materials, and preparation of tooth surfaces prior to pit and fissure sealant and composite restorations. No specific patient population or contraindications provided.

Regulatory Classification

Identification

An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

Special Controls

The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”

Predicate Devices

• Danville Engineering PrepStar Cavity Preparation System
• Sunrise Technologies MicroPrep Cavity Preparation System

Submission Summary (Full Text)

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#### JUL - 9 1998

Prep Technology Corp.

# 510(k) Summary of Safety and Effectiveness Prep Technology Corp. PrepTech 200TM Cavity Preparation System

# Statement of Intended Use:

The Prep Technology Corp. PrepTech 200TM Cavity Preparation System is intended for use in cavity preparation for bonded restorations, the removal of decayed or sound tooth structure and composite restoration materials and for the preparation of tooth surfaces prior to pit and fissure sealant and composite restorations.

### Submitted by:

Prep Technology Corp. 43204 Christy Street Fremont, CA 9538 Tel: [phone] Fax: [phone]

Contact Person:

Joe W. Shaffer President Telephone: [phone]

Date Summary Prepared:

November 15, 1997

Name of the Device:

Proprietary Name:

PrepTech 200TM Cavity Preparation System

Common/ Usual Name: Air Abrasive System for Dental Applications

Classification Name:

Airbrush (per 21 CFR 872.6080)

Proprietary Data: This document and the information contained herein may not be reproduced used or disclosed without prior written consent of Prep Technology Corp.

E.2

,

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## Predicate Devices:

Danville Engineering PrepStar Cavity Preparation System Sunrise Technologies MicroPrep Cavity Preparation System

Description:

The Prep Technology Corp. PrepTech 200 Cavity Preparation System is a device that combines pressurized air and aluminum oxide powder to produce a high velocity stream of kinetic particles to perform dental restorative procedures, including preparation for pit and fissure sealants and composite restorations.

Comparison to Predicate Devices:

The PrepTech 200 Cavity Preparation System has been compared to legally marketed devices with respect to intended use and technological characteristics. The comparison results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping to symbolize the department's focus on people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 1998

Mr. Joe W. Shaffer President Prep Technology Corporation 43204 Christy Street 94538 Fremont, California

K974655 Re : PrepTech 200™ Cavity Preparation System Trade Name: Requlatory Class: III KOJ Product Code: Dated: November 15, 1997 Received: December 15, 1997

Dear Mr. Shaffer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Shaffer

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timo hy A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known): Not Yet Assigned

Device Name: Prep Technology Corp. PrepTech™ 200 Cavity Preparation System

Indications For Use:

The Prep Technology Corp. PrepTech 200 Cavity Preparation System is intended for use in cavity preparation for bonded restorations, the removal of decayed or sound tooth structure and composite restoration materials and for the preparation of tooth surfaces prior to pit and fissure sealant and composite restorations.

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

(Division Sign-Off)Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Dental, Infection Con and General Hospita 510(k) Number

OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Prep Technology Corp.