PREPAIR

K033215 · Danville Materials, Inc. · KOJ · Jan 9, 2004 · Dental

Device Facts

• Record ID: K033215
• Device Name: PREPAIR
• Applicant: Danville Materials, Inc.
• Product Code: KOJ · Dental
• Decision Date: Jan 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PrepAir is intended for the cutting and preparation of all classes of cavity restorations; removal of composite resin fillings; surface roughening of enamel, dentin, metals and composite surfaces prior to adhesive resin bonding; preparation of pits and fissures prior to sealing; cleaning and removal of cements and adhesives from bridges and crowns prior to re-cementation; and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.

Device Story

PrepAir is a dental airbrush device; utilizes aluminum oxide abrasive particles for surface preparation. Used by dental professionals in clinical settings for cavity preparation, removal of composite fillings, surface roughening of enamel/dentin/metals/composites, pit and fissure preparation, and cleaning of dental prosthetics. Operates via air-driven abrasion to remove material or increase surface area for adhesive bonding. Enhances retention for restorations and orthodontic appliances; facilitates efficient removal of cements and adhesives. Device provides mechanical cutting/abrading action; output is controlled by the clinician to achieve desired surface texture or material removal.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental airbrush; utilizes aluminum oxide abrasive media; air-driven mechanical abrasion; handheld form factor; non-electronic/mechanical operation.

Indications for Use

Indicated for dental professionals performing cavity preparation, composite resin removal, surface roughening for bonding, pit and fissure preparation, cement/adhesive removal, and orthodontic bracket/band surface preparation.

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

• PrepStart by Danville Engineering (K970589)
• PrepTech by Prep Technology Corp (K974655)
• AirDent by Air Techniques (K981564)
• Rondoflex by Kavo America (K002708)

Submission Summary (Full Text)

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## JAN - 9 2004

:

## 510(k) Summary of Safety and Effectiveness (As Required by 21 C.F.R. §807.92)

| Applicant: | Danville Materials, Inc.<br>2021 Omega Dr.<br>San Ramon, CA 94583 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Craig R. Bruns<br>Phone [phone]<br>Fax [phone]<br>e-mail: [e-mail] |
| Date of summary | September 29, 2003 |
| Device name | PrepAir |
| Common name | Airbrush |
| Classification names | Regulation Number<br>21 CFR 872.6080 |
| | Product Code<br>KOJ |
| Device Description | The PrepAir is a dental airbrush using aluminum oxide to prepare all classes of<br>caivty prior to restoration. |
| Predicate Device | The device is substantially equivalent to other legally marketed devices in the<br>United States including PrepStart by Danville Engineering (K970589),<br>PrepTech by Prep Technology Corp (K974655), AirDent by Air Techniques<br>(K981564) and Rondoflex by Kavo America (K002708). |
| Intended Use | The PrepAir is intended for the cutting and preparation of all classes of cavity<br>restorations; removal of composite resin fillings; surface roughening of<br>enamel, dentin, metals and composite surfaces prior to adhesive resin bonding;<br>preparation of pits and fissures prior to sealing; cleaning and removal of<br>cements and adhesives from bridges and crowns prior to re-cementation; and<br>preparation of adhesive surfaces of orthodontic bands and brackets to increase<br>retention. |

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ENClosure 3

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 2004

Mr. Craig R. Bruns Danville Materials Incorporated 2021 Omega Road San Ramon, California 94583-1229

Re: K033215

Trade/Device Name: PrepAir Regulation Number: 872.6080 Regulation Name: Airbrush Regulatory Class: KOJ Product Code: II Dated: December 30, 2003 Received: January 2, 2004

Dear Mr. Bruns:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to revea 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 morslate octimers of 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 appear as upportions 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 adultcration.

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 (1 Writ), it may of bund 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. Bruns

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.

Qre

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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## Indications for Use

510(k) Number (if known): _K033215

PrepAir Device Name __________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The PrupAir is intended for the cutting and preparation of all classes of cavity The FripAll is intended for the out.its in fillings; surface roughering of enamel, dentin, restorations, removel or composite room Mings, preparation of pits and fieldis and composite ournated provide of cements and adhesives from bridges and crowns prior to re-cementation, and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

McCall for MSR

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(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental De

510(k) Number: