RINSENDO by AIR TECHNIQUES, INC.

The provided text is a 510(k) clearance letter from the FDA for a device called "RinsEndo". This document confirms that the device is substantially equivalent to a legally marketed predicate device for its indicated use (root canal irrigation/disinfection) and allows it to be marketed.

However, the document does NOT contain any information regarding:

Acceptance criteria for the device's performance.
The specifics of any study performed to prove the device meets acceptance criteria.
Device performance results.
Sample sizes for test or training sets.
Data provenance.
Number or qualifications of experts for ground truth.
Adjudication methods.
MRMC comparative effectiveness study details or effect sizes.
Standalone algorithm performance.
Type of ground truth used.
How ground truth for training was established.

This 510(k) letter is an administrative document about market clearance, not a technical report detailing the performance evaluation studies. Therefore, I cannot extract the requested information from the provided text.

Summary

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Public Health Service

MAY 2 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joseph Carey Director of Quality Assurance Air Techniques, Incorporated 70 Cantiague Rock Road Hicksville, New York 11801

Re: K052271

Trade/Device Name: RinsEndo Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: NYL Dated: April 11, 2006 Received: April 26, 2006

Dear Mr. Carey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Carey

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Punose
Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _1_of 1

ltem 10 STATEMENT OF INDICATIONS FOR USE:

510K Number (if known): __ K052271

Device Name: _________ RinsEndo

The RinsEndo is used for root canal irrigation/ disinfection.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Lane

colology, General Huspitъ: 1611

Prescription Use V (Per 21 CFR 801.109)

Over the counter use (Optional Format 1-2-96)

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.