DISPODRILL

K993124 · Kis Products · KOJ · Aug 6, 2001 · Dental

Device Facts

• Record ID: K993124
• Device Name: DISPODRILL
• Applicant: Kis Products
• Product Code: KOJ · Dental
• Decision Date: Aug 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cutting and preparation of tooth structure, both enamel and dentin for all classes of cavity Cutting and preparation of tooth stracture, ooth onainer and/or abrasion of tooth surfaces and dental restorations to enhance adhesive restorative procedures.

Device Story

DispoDrill™ is a disposable dental air abrasion handpiece. It functions by delivering an abrasive stream to cut or prepare tooth structure and dental restorations. Used by dentists in clinical settings to facilitate adhesive restorative procedures. The device is intended to be a single-use, disposable alternative to reusable air abrasion systems.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Disposable air abrasion handpiece. Operates via pneumatic delivery of abrasive media for tooth structure removal. Form factor is a handheld dental instrument designed for single-use application.

Indications for Use

Indicated for cutting and preparation of tooth structure (enamel and dentin) for all cavity classes and abrasion of tooth surfaces/restorations to enhance adhesive restorative procedures. For use by dentists only.

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

• PrepStar™ by Danville Engineering Inc.

Submission Summary (Full Text)

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**AUG 6 2001**
1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Reuben Hertz, DDS, FAGD Vice President, KIS Products, Inc. 2318 Sea Island Drive Fort Lauderdale, FL 33301

K993124 Re : Disposable Dental Air Abrasion Handpiece Trade Name: Regulatory Class: III Product Code: KOJ Dated: September 16, 1999 September 20, 1999 Received:

Dear Mr. Hertz:

We have reviewed your Section 510(k) notification of intent to we have levice your beloced above and we have determined the market increatially equivalent (for the indications for device Is subscancially equivalore (colors) to devices marketed in interstate use stated in tho May 28, 1976, the enactment date of the Commerce prior co nayents, or to devices that have been Medical Device Amendically, sith the provisions of the Federal You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. of the ACC. The general onnual registration, listing of Include requirmanufacturing practice, labeling, and devices, good manazacous 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 be Bubjeot of Becting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ਼ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices; General (GMP) regulation (21 CFR Part 820) and that, through periodic (Gri ) regulacions, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP vertif back abbamay regulatory action. In addition, FDA may publish further announcements concerning your device in

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## Page 2 - Mr. Hertz

this response to your Please note: the Federal Register. the Federal Register. Freadorion does not affect any premarker notification submited at ations 531 through 542 of obligation you might have uner bestronic Product Radiation the Act for devices under the Eccocient was or regulations.

This letter will allow you to begin marketing your device as This letter will allow you co begin attification. The FDA described in your 510\x7 prematic of your device to a legally
finding of substantial equivalence of classification for your finding of substancial equivalies of plassification for your marketed predicate device resures in a claboration of the market.

If you desire specific advice for your device on our labeling If you desire specific acvice rolled roll on the office of regulation (21 CFR Farc 001 and se contact the Office of vitro diagnostic devices), prease otionally, for questions on Compliance at [phone]. Friday device, please contact the promotion and advertising on your ac3935 Pilso, please note the regulation entitled, "Misbranding by reference to the regulation entification" (21 CFR 807.97) Other general premarket notification - (2) cir car car the Act may be information on your responsible and Manufacturers Assistance obtained from the bivision or 6m8-2041 or [phone] or at at its toll-lree number (800) 050 aa. v/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | not issued K993124 |
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DispoDrill™ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Cutting and preparation of tooth structure, both enamel and dentin for all classes of cavity Cutting and preparation of tooth stracture, ooth onainer and/or abrasion of tooth surfaces and dental restorations to enhance adhesive restorative procedures.

Indications for use are identical to PrepStar™ by Danville Engineering Inc.

For Use by Dentists Only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Saisen Runney

(Division Sign-Off) Civision of Dental, Infection Control. and General Hospital Device । यह 5 : O(k) Number J Over-The-Counter Use_ OR

Prescription Use (Per 21 CFR 801.109)