ASC-12 PIEZOELECTRIC SCALER

{0}------------------------------------------------ K0708166 Telephone: (425) 487-3157 Image /page/0/Picture/1 description: The image shows a logo for "ASEPTICO International". The logo features stylized, bold lettering for the word "ASEPTICO", with the word "International" written in a smaller, elegant font underneath. To the right of the text is a graphic that resembles a globe, adding a global or international dimension to the brand's identity. Fax: (360) 668-8722 Web: www.aseptico.com E-mail: mwaller@aseptico.com Aseptico Inc. · 8333 216" St SE · Woodinville, WA 98072 APR 1 1 2007 # 510(k) Summary Grant Ramaley, Director of Regulatory Affairs Contact: Date Prepared: January 10, 2007 Trade or Proprietary Name: Model ASC-12 Piezoelectric Scaler Classification Name: 8872.4850 Ultrasonic scaler 510(k) Number: Device Description: The ASC-12 is an AC mains-powered piezoelectric ultrasonic scaler The device consists of a console, a intended for scaling and endodontic procedures. footswitch and an autoclavable handpiece with interchangeable and autoclavable scaling tips. The following intended were validated by establishing equivalent scaler tip amplitudes and power settings between a predicate device using their prescribed power settings for the exact same scaler tips to be used with the ASC-12. See tip movement compatibility data. ## Features of Substantial Eguivalence to the Satelec Suprasson P5 Booster - 510(k) #K961158 and the NSK Varios 350 - 510(k) #K031421 | 1) Intended Use: scaling and endodontic procedures, including: | | |----------------------------------------------------------------|-------------------------------------------------------| | Scaling: | Interdentium treatment | | | Tooth neck and subgingival treatment | | | Treatment of large dental calculi | | | Treatment of coatings and tobacco stains | | | Treatment of periodontal pockets | | | Interproximal treatment | | | Loosening of crowns and posts | | Endodontics: | Pulp Chamber Cleaning | | | Canal filling by ultrasonic gutta-percha condensation | - 2) Design & Construction: AC mains-powered piezoelectric ultrasonic scaler consisting of a console, a footswitch and a handpiece with interchangeable scaling tips. Coolant may be supplied by connection to an external water source. - Sterility Assurance: Handpiece and scaling tips are removable and autoclavable 3) - 4) Performance: - a. The vibration frequency is between 27 and 32 kHz - b. Scaler coolant flow is between 12 ml and 82 ml at the tip - c. Water pressure rating is between 14.5 to 73 pso (1 to 5 bar) - 5) Electrical Safety Specifications: Class II equipment with Type BF applied part {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA", indicating the department's name and national affiliation. APR 1 1 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Aseptico, Incorporated C/O Ms. Casey Conry Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747 Re: K070866 Trade/Device Name: ASC-12 Piezoelectric Scaler Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: March 26, 2007 Received: March 29, 2007 Dear Ms. Conry: 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. Conry 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. Smythe Y. Michie Davis. 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}------------------------------------------------ ## Indications for Use K070866 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: ASC-12 Piezoelectric Scaler Indications for Use: The ASC-12 is an ultrasonic scaler that is intended for the following procedures: #### Scaling: Interdentium treatment Tooth neck and subgingival treatment Treatment of large dental calculi Treatment of coatings and tobacco stains Treatment of periodontal pockets Interproximal treatment Loosening of crowns and posts ### Endodontics: Pulp Chamber Cleaning Canal filling by ultrasonic gutta-percha condensation Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Susan Concurrence of CDRH, Office of Device Evaluation (ODE) entologic Corporal Hospital 11 11:21: ion Gentrol, Dental Devioes . (k) Number..