AIR TECHNIQUES' AIRDENT II

K981564 · Air Techniques, Inc. · KOJ · Sep 24, 1998 · Dental

Device Facts

• Record ID: K981564
• Device Name: AIR TECHNIQUES' AIRDENT II
• Applicant: Air Techniques, Inc.
• Product Code: KOJ · Dental
• Decision Date: Sep 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AIRDENT II AIR ABRASION SYSTEM is designed for use by Dentists and sold through authorized Air Techniques' Dealers for the following purposes: 1-Cavity preparations for composite restorations and small amalgam fillings and preparations for aesthetic composite procedures. 2-Composite restoration removal. 3-Partial composite restoration removal and repair or rebonding at failure sites. 4-Preparation for pit and fissure sealants. 5-Etching of tooth structure and porcelain for bonding. Acid etching materials should be used in conjunction with the AIRDENT II in bonding procedures.

Device Story

AirDent II is an air abrasion system used by dentists for cavity preparation and surface etching. Device utilizes high-velocity stream of abrasive particles to remove tooth structure or restorative material. Operated by dental professionals in clinical settings. Output is mechanical abrasion of target dental surfaces. Benefits include minimally invasive preparation of cavities and surface conditioning for bonding procedures. Device functions as a mechanical tool; no electronic processing or software involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Air abrasion system; mechanical operation using abrasive particles for tooth structure removal and surface etching. Standalone dental equipment.

Indications for Use

Indicated for dental patients requiring cavity preparation for composite/amalgam restorations, composite removal, repair/rebonding of restorations, pit and fissure sealant preparation, and etching of tooth structure or porcelain for bonding.

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.”

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1998

Mr. Joseph Carey ·Air Techniques, Incorporated 70 Cantiague Rock Road P.O. Box 870 Hicksville, New York 11801

Re: K981564 Trade Name: Air Techniques' AirDent II Regulatory Class: III Product Code: KOJ April 29, 1998 Dated: Received: May 1, 1998

Dear Mr. Garey:

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 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 (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. ಗಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of ww

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Page 2 - Mr. Carey

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 labelinq requlation (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,

Patricia Cucentiffer

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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Page of

510(k) Number (if known): K98-1564

Device Name: _________________________________________________________________________________________________________________________________________________________________

## Indications For Use:

The AIRDENT II AIR ABRASION SYSTEM is designed for use by Dentists and sold through authorized Air Techniques' Dealers for the following purposes:

l-Cavity preparations for composite restorations and small amalgam fillings and preparations for aesthetic composite procedures. Jo

2-Composite restoration removal.

3-Partial composite restoration removal and repair or rebonding at failure sites. 4-Preparation for pit and fissure sealants.

- 5-Etching of tooth structure and porcelain for bonding.
Acid etching materials should be used in conjunction with the AIRDENT II in bonding procedures.

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

Concu rence of CDRH, Office of Device Evaluation (ODE)

Susan Perry

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)