STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT

{0}------------------------------------------------ K070307 ## SECTION 5: 510(In) SUMMARY MAY - 2 2007 DENTSPLY Internation Susquehanna Commerce Center We 221 West Philadelphia Street, Suite York, PA 17405-08 | CONTACT: | Helen Lewis | |----------|-------------| |----------|-------------| January 31, 2007 DATE PREPARED: TRADE OR PROPRIETARY NAME: Steri-Mate Handpiece Sleeve with LED Light CLASSIFICATION NAME: Scaler, Ultrasonic CLASSIFICATION: Class II REGULATION NUMBER: 21CFR 872.4850 #### PREDICATE DEVICES: Steri-Mate Handpiece for Cavitron JET Unit (CJ Handpiece), K 941392 ### DEVICE DESCRIPTION: The Steri-Mate Handpiece Sleeve with LED Light is an accessory that easily slides over the Steri-Mate handpiece (predicate device) to generate a focused light to illuminate the clinician's working area during an ultrasonic procedure. The sleeve uses the energy generated from the Steri-Mate handpiece to generate light output when the ultrasonic unit's foot control is activated. #### INTENDED USE: 1. Provides illumination to enhance visibility in the clinical working area during ultrasonic scaling procedures with the Steri-Mate handpiece. 2. When the lighted sleeve is installed on the Steri-Mate handpiece, the soft tapered grip provides multiple pinch points, to enhance ergonomics and improve clinician comfort. 3, The Steri-Mate handpiece with the lighted sleeve is steam sterilizeable which reduces the risk of cross contamination. #### TECHNOLOGICAL CHARACTERISTICS: All of the components found in Steri-Mate Handpiece Sleeve with LED Light have been used in legally marketed devices and/or were found safe for dental use. The Steri-Mate Handpiece Sleeve with LED Light has been evaluated and passed biocompatibility testing for L929 MEM Elution Test - ISO, Oral Irritation Test - Acute Exposure - ISO and Kligman Maximization Test -180 We believe that the prior use of the components of the Steri-Mate Handpiece Sleeve with LED Light in legally marketed devices, the performance clata provided, and the biocompatibility data provided support the safety and effectiveness of the Steri-Mate Handpiece Sleeve with LED Light for the indicated uses. 000009 {1}------------------------------------------------ Image /page/1/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 an abstract image of an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY - 2 2007 Ms. Helen Lewis Director of Corporate Compliance & Regulatory Affairs DENTSPLY International, Incorporated 221 West Philadelphia Street, Suite 60 Susquehanna Commerce Center York, Pennsylvania 17404 Re: K070307 Trade/Device Name: Steri-Mate Handpiece Sleeve with LED Light Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: January 31, 2007 Received: February 1, 2007 Dear Ms. Lewis: 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. {2}------------------------------------------------ Page 2 -Ms. Lewis 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 Runnes 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 {3}------------------------------------------------ # SECTION 4: INDICATIONS FOR USE 510(k) Number (if known): K6 703017 Device Name: Steri-Mate Handpiece Sleeve with LED Light Indications for Use: The Steri-Mate Handpiece Sleeve with LED Light is indicated for: 1. Provides illumination to enhance visibility in the clinical working area during ultrasonic scaling procedures with the Steri-Mate handpiece. 2. When the lighted sleeve is installed on the Steri-Mate handpiece, the soft tapered grip provides multiple pinch points, to enhance ergonomics and improve clinicia, confort. 3. The Steri-Mate handpiece with the lighted sleeve is steam sterlizeable which reduces the risk of cross contamination. Susan Rumer f Anesthesiology, General Hospital, Control, Dental Devices ) Number: K070507 Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------ Concurrence of CDRH, Office of Device Evaluation (ODE) 000008