MICROETCHER AP

K970589 · Danville Engineering, Inc. · KOJ · Sep 17, 1997 · Dental

Device Facts

• Record ID: K970589
• Device Name: MICROETCHER AP
• Applicant: Danville Engineering, Inc.
• Product Code: KOJ · Dental
• Decision Date: Sep 17, 1997
• 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 preparations. Removal of composite resin restorations. Surface roughening of enamel, dentin, and metal dental structures prior to adhesive resin bonding.

Device Story

Microetcher AP is a dental air-abrasion device used by dentists for cavity preparation and surface treatment. Device uses compressed air to propel abrasive particles against tooth structure or dental materials. Enables precise cutting of enamel and dentin; facilitates removal of composite resin; creates micro-retentive surface texture on enamel, dentin, and metal to improve adhesive bonding. Operated by dental professionals in clinical settings. Benefits include minimally invasive tooth preparation and enhanced bond strength for restorative procedures.

Clinical Evidence

bench testing only

Technological Characteristics

Air-abrasion dental instrument; utilizes compressed air and abrasive media for mechanical surface modification. Manual handheld form factor. No electronic components or software.

Indications for Use

Indicated for dental patients requiring tooth structure preparation (enamel/dentin) for cavity restorations, removal of composite resin, or surface roughening of enamel, dentin, and metal structures for adhesive 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

SEP 17 1997

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Craig R. Bruns
Danville Engineering, Incorporated
2021 Omega Drive
San Ramon, California 94583

Re: K970589
Trade Name: Microetcher Ap
Regulatory Class: II
Product Code: KOJ
Dated: February 11, 1997
Received: February 18, 1997

Dear Mr. Bruns:

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 Regulations, Title 21, Parts 800 to 895. A 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Bruns

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 at [phone].

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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Feb-28-97 07:08A Danville Engineering 510 838 0944 P.04

Page 1 of 1

510(k) Number: K97-0589

Device Name: Microetcher AP

Indications for Use:

Cutting and preparation of tooth structure, both enamel and dentin for all classes of cavity preparations. Removal of composite resin restorations. Surface roughening of enamel, dentin, and metal dental structures prior to adhesive resin bonding.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Susan Runnar
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K970589

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)