AEROETCHER

K973679 · Parkell, Inc. · KOJ · Mar 10, 1998 · Dental

Device Facts

• Record ID: K973679
• Device Name: AEROETCHER
• Applicant: Parkell, Inc.
• Product Code: KOJ · Dental
• Decision Date: Mar 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2

Intended Use

An air-driven device that permits the user to abrade surfaces of dental materials, either intra- or extra-orally, in order to enhance the bond strength of resinous materials applied to the air-abraded surfaces and polymerized thereon.

Device Story

AEROETCHER is an air-driven dental sandblaster; delivers 50um-grit aluminum oxide abrasive to substrates. Used by dental professionals in clinical settings to prepare surfaces for resinous material bonding. Device enhances bond strength via surface abrasion. Operation involves air-driven delivery of abrasive media. Output is physical surface modification. Benefits include improved adhesion of dental restorations or materials.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Air-driven abrasive delivery system; utilizes 50um-grit aluminum oxide. Handheld dental instrument form factor. No software or electronic components.

Indications for Use

Indicated for dental professionals to abrade dental material surfaces, intra- or extra-orally, to improve bond strength of resinous materials.

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

• MICROETCHER
• ACCU-PREP

Submission Summary (Full Text)

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MAR 10 1998

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## Submitter:

Contact:

Submission Date:

Trade Name:

Common Name:

Classification Name:

Equivalence:

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Description/Intended Use:

## K973679

## 510(k) SUMMARY

Parkell Products Inc. 155 Schmitt Blvd. Box 376 Farmingdale, NY 11735 TEL: [phone] FAX: [phone]

Nelson J. Gendusa, DDS Director of Research Parkell 155 Schmitt Blvd. Box 376 Farmingdale, NY 11735

22 September, 1997

AEROETCHER

Sandblaster

Airbrush

MICROETCHER; ACCU-PREP

AEROETCHER may be described as an air-driven device that delivers an abrasive material (50um-grit aluminum oxide) to a substrate in order to enhance the bond strength of polymerizable resinous material to that substrate. It is substantially equivalent to the cited predicate devices in its mode of operation, but differs from them in cosmetic design and triggering mechanism.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with three parallel lines forming the staff and a snake winding around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 1998

Nelson J. Gendusa, DDS ·Director of Research Parkell Products, Incorporated 155 Schmitt Boulevard P.O. Box 376 Farmingdale, New York 11735

Re : K973679 Trade Name: AEROETCHER Requlatory Class: III Product Code: KOJ Dated: September 23, 1997 September 26, 1997 Received:

Dear Dr. Gendusa:

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, 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 requlations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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. Please note: concerning your device in the Federal Reqister. this response to your premarket notification submission does not affect any obligation you might have under sections 531

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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 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):

Device Name:

AEROETCHER

Indications For Use:

An air-driven device that permits the user to abrade surfaces of dental materials, either intra- or extra-orally, in order to enhance the bond strength of resinous materials applied to the air-abraded surfaces and polymerized thereon.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. R973679

Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)