(146 days)
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.
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.
Not Found
I apologize, but the provided text is a 510(k) clearance letter for the Air Techniques' AirDent II device. This document primarily focuses on regulatory approval and indications for use, and it does not contain the detailed information required to describe the acceptance criteria and a study proving the device meets those criteria, as outlined in your request.
Specifically, the document does not provide any of the following:
- A table of acceptance criteria and reported device performance.
- Sample size for test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Information about standalone (algorithm-only) performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Therefore, I cannot fulfill your request using the provided input.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)
§ 872.6080 Airbrush.
(a)
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.(b)
Classification. Class II. 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.”