RINSENDO

K052271 · Air Techniques, Inc. · NYL · May 26, 2006 · Dental

Device Facts

• Record ID: K052271
• Device Name: RINSENDO
• Applicant: Air Techniques, Inc.
• Product Code: NYL · Dental
• Decision Date: May 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The RinsEndo is used for root canal irrigation/ disinfection.

Device Story

RinsEndo is a dental device used for root canal irrigation and disinfection. It functions as a handpiece accessory to facilitate the cleaning of root canal systems. Used in a clinical dental setting by a dentist or endodontist, the device assists in the removal of debris and the delivery of irrigating solutions to the canal space. By improving the efficiency of the irrigation process, it aids in the disinfection of the root canal, potentially improving the success rate of endodontic therapy.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device classification and intended use.

Technological Characteristics

Dental handpiece accessory for root canal irrigation. Mechanical device; no software or electronic components described.

Indications for Use

Indicated for root canal irrigation and disinfection in patients undergoing endodontic procedures.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of a bird or abstract human figures, represented by three curved lines.

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 [phone]. 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 [phone] or [phone] 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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## ltem 10 STATEMENT OF INDICATIONS FOR USE:

510K Number (if known): __ K052271

Device Name: _________ RinsEndo

The RinsEndo is used for root canal irrigation/ disinfection.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Lane

colology, General Huspitъ: 1611

Prescription Use V (Per 21 CFR 801.109)

or

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