QUANTEC-E ENDO SYSTEM

{0}------------------------------------------------ K990739 ## SYBRON DENTAL SPECIALTIES # Section III - 510(k) Summary of Safety and Effectiveness ## Submitter: Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person March 1999 Date Summary Prepared: #### Device Name: - Trade Name Quantec-E Endo System . - . Common Name - AC-Powered Dental Handpiece - Classification Name Dental Handpiece and Accessories, per 21 CFR § 872.4200 . #### Devices for Which Substantial Equivalence is Claimed: - Micro Motors, Inc., DynaSurq Electric Handpiece and Irrigation System . ### Device Description: The device is an AC-powered unit consisting of a controller console, foot pedal and motor intended to be used in dentistry to drive dental handpieces. The motor has a maximum 1:1 drive output of 20,000 RPM's. This output can be geared up or down with the appropriate handpiece. The unit is supplied with both a 110V and 220V power cord. The entire motor assembly of the Quantec-E Endo System is autoclavable. The unit has an accessory port located on the rear panel of the device which may be used to attach accessory devices. One such device may include a pump that may deliver irrigation fluids. ### Intended Use of the Device: The intended use of the Quantec-E Endo System is to drive dental handpieces. ### Substantial Equivalence: The Quantec-E Endo System is substantially equivalent to several other legally marketed devices in the United States. The Quantec-E Endo System functions in a manner similar to and is intended for the same use as the DynaSurg Electric Handpiece and Irrigation System designed by Micro Motors, Inc. {1}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with a staff and two snakes. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 6 1999 Ms. Colleen Boswell Manager, Requlatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867 Re : K990739 Quantec-E Endo System Trade Name: Regulatory Class: I Product Code: EKX Dated: March 4, 1999 March 5, 1999 Received: Dear Ms. Boswell: 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 The general controls provisions of the Act 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 - Ms. Boswell this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of 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 labeling 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, Patruo Cuciniello Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Section I - Indications for Use 510(k) Number: K990739 Quantec-E Endo System Device Name: Indications for Use: The Quantec-E Endo System is an AC-powered unit consisting of a controller console, foot pedal and motor intended to be used in dentistry to drive dental handpieces. Susan Runne (Division Sign-Off Division of Dental, Info and General Hospital I 510(k) Number **Prescription Use** (Per 21 CFR 801.109) (Per 21 CFR 801.109)