AIRPREP SYSTEM - MODEL 9001

K974488 · Asi Medical, Inc. · KOJ · May 26, 1998 · Dental

Device Facts

• Record ID: K974488
• Device Name: AIRPREP SYSTEM - MODEL 9001
• Applicant: Asi Medical, Inc.
• Product Code: KOJ · Dental
• Decision Date: May 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restorations.

Device Story

AirPrep System (Model 9001) is a table-top air abrasion instrument; incorporates Micadent air abrasion system within a housing; includes a membrane air dryer. Device used by dental professionals for intra-oral procedures; performs etching and surface preparation for composite restorations. Operates via air abrasion technology to modify tooth surfaces. System supplied as a completed product to ASI Medical. Clinical benefit includes efficient surface preparation for restorative dental procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and functional similarity to the predicate device.

Technological Characteristics

Table-top air abrasion instrument; includes membrane air dryer; utilizes Micadent handpiece. Mechanical operation via air abrasion for surface etching.

Indications for Use

Indicated for intra-oral air abrasion procedures, specifically etching and surface preparation for composite restorations.

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

• Micadent (manufactured by Hampton Research and marketed by Medidenta International)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 26 1998
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. John W. McPeek
President
ASI Medical, Incorporated
14550 East Easter Avenue, Suite 1000
Englewood, Colorado 80112

Re: K974488
Trade Name: Airprep System - Model 9001
Regulatory Class: III
Product Code: KOJ
Dated: November 25, 1997
Received: November 26, 1997

Dear Mr. McPeek:

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 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 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

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Page 2 - Mr. McPeek

through 542 of 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 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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DEC-04-1997 12:35
75543501
Page 1 of 1

510(k) Number (if known): Applied 11/25/97

Device Name: Table-Top Air Abrasion Instrument

Indications For Use:

The AirPrep System incorporates the Micadent air abrasion system mounted inside the unit housing along with a membrane air dryer. The Micadent handpiece is mounted in a holder along the outside of the housing.

The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restorations.

The AirPrep System is substantially similar in design and function as the Micadent manufactured by Hampton Research and marketed by Medidenta International. The Micadent will be supplied to ASI as a completed product. The AirPrep will be only marketed for the same purposes as the Micadent.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Raines

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number 19974488

Prescription Use ☑ (Per 21 CFR 801.109)

OR

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

DEC-02-1997 12:03
301 480 3002
96%
P.02
TOTAL P.03