NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES

{0}------------------------------------------------ KA71319 MAY 2 2 1997 # SECTION 15 # SUMMARY OF SAFETY AND EFFECTIVENESS Q 1 {1}------------------------------------------------ #### SECTION 15: SUMMARY OF SAFETY AND EFFECTIVENESS This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. #### SUBMITTER INFORMATION 15.1 | a. | Company Name: | Tycom Dental | |----|------------------------|----------------------------------------------------| | b. | Company Address: | 17802 Fitch Avenue<br>Irvine, CA 92714 | | c. | Company Phone: | (714) 955-0800 | | d. | Contact Person: | Patrick Johnson<br>General Manager<br>Tycom Dental | | e. | Date Summary Prepared: | March 27, 1997 | ### 15.2. DEVICE IDENTIFICATION るこ g | a. | Trade/Proprietary Name: | NT and Mac Series Endodontic Files | |----|-------------------------|------------------------------------| |----|-------------------------|------------------------------------| - b. Classification Name(s): Pulp Canal, Endodontic File ### 15.3 IDENTIFICATION OF PREDICATE DEVICE . . | Company | Device | 510(k) No. | Date Cleared | |--------------|---------------------|------------|--------------| | Tycom Dental | Quantec Series 2000 | K962031 | June 4, 1996 | {2}------------------------------------------------ #### DEVICE DESCRIPTION 15.4 The NT and Mac Series Endodontic Files are a series of engine (rotary) driven and hand driven endodontic files for use in root canal preparation. The files are constructed of nickel-titanium and color coded for ease of use. The files are available in 21 and 25mm lengths and ten graduating sizes. #### 15.2 SUBSTANTIAL EQUIVALENCE The Mac Series Endodontic hand files are substantially equivalent to the Tycom Dental Quantec Series 2000 hand files in terms of intended use and technological characteristics. The NT Series Endodontic engine files are substantially equivalent to the Tycom Dental Quantec Series 2000 engine files in terms of intended use and technological characteristics. The fundamental characteristics of the device are similar to those of the predicate devices and are listed on the comparison charts provided in this 510(k) submission. #### 15.6 INTENDED USE る。 The NT and Mac Series Endodontic Files are designed for use in root canal preparation. #### TECHNOLOGICAL CHARACTERISTICS 15.7 A comparison of the technological characteristics of the predicate and legally marketed devices is provided in this submission. {3}------------------------------------------------ #### 15.8 510(K) CHECKLIST 1999 - 1999 ィー े .............................................................................................................................................................................. This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission. بعد القرب المقابل المنتخب المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتخب المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتخب {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 2 1997 Tvcom Dental C/O Carol L. Patterson Consultant Patterson Consulting Group, Incorporated 18140 Smokesignal Drive San Diego, California 92127 Re : K971319 NT Series Endodontic Files, Mac Series Trade Name: Endodontic Files Regulatory Class: I Product Code: EKS Dated: March 27, 1997 Received: April 10, 1997 Dear Ms. Patterson: 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 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 (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. प्र substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {5}------------------------------------------------ Page 2 - Ms. Patterson 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 regulation (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, Timothy A. Ulatowski hy A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## INDICATIONS FOR USE ﺎﺕ ﻣ 510(k) Number: To Be Assigned By FDA NT and Mac Series Endodontic Files Device Name: Indications For Use: The NT and Mac Series Endodontic Files are engine files and hand instruments designed for use in root canal preparation. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Rumny (Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices 510(k) Number ડી Prescription Use V な li OR Over-The-Counter Use (Per 21 CFR 801.109)