REFERENCE

{0}------------------------------------------------ # K9929 #### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS II. ### Submitter | Name: | ESPE Dental AG | |------------------------------------|-----------------------------------------------------------| | Street: | ESPE Platz | | ZIP-Code, City: | D-82229 Seefeld | | Federal State: | Bavaria | | Country: | Germany | | Establishment Registration Number: | 9611385 | | Contact: | Dr. Andreas Petermann, Manager of U.S. Regulatory Affairs | | Phone: | 011-49-8152-700 1395 | | Fax: | 011-49-8152-700 1869 | | E-mail: | Andreas_Petermann@ESPE.de | | Date: | August 31, 1999 | | <b>Name of Device</b> | | | Proprietary Name: | REFERENCE® | | Classification Name: | Tooth shade resin material | | Common Name: | Composite restorative material | | <b>Predicate Devices</b> | | | PERTAC® II by ESPE | K 962440 | | PROMPT® L-POP by ESPE | K 984246 | | HYTAC® by ESPE | K 962442 | | KETAC®-MOLAR by ESPE | K 960954 | Image /page/0/Picture/5 description: The image shows the logo for ESPE. The logo includes the text "510(k) REFERENCE" with a registered trademark symbol. Below the text is a symbol of a tree inside of a square, followed by the text "ESPE" in a bold, sans-serif font. {1}------------------------------------------------ #### Description for the Premarket Notification REFERENCE® is classified as a tooth shade resin material (21 C.F.R. § 872.3690) because it is a device composed of methacrylates intended to restore carious lesions or structural defects in teeth. REFERENCE® is similar in intended use and substantially equivalent to ESPE's previously 510(k) cleared composite filling material PERTAC® II. REFERENCE® is a further development based on the experience with PERTAC® II. The material characteristics were improved to obtain better handling and wearing properties. Furthermore, REFERENCE® is able to release fluoride ions. ESPE's glass ionomer filling material KETAC®-MOLAR is provided as a predicate fluoride releasing device, therefore. All ingredients of REFERENCE® were used in PERTAC® II, except two chemical compounds which are, however, contained in ESPE's 510(k) cleared compomer bonding material PROMPT® L-POP® and in ESPE's 510(k) cleared compomer restorative material HYTA0 . In addition, biocompatibility tests were carried out to ensure the safety of REFERENCE®. The results show that REFERENCE® is a safe device with no harmful potential. In particular, REFERENCE® has the following similarities to its predecessor PERTAC® II: - REFERENCE® has in general the same intended use . - . REFERENCE® is used by the same operating principles - . REFERENCE® incorporates the same basic chemical design - REFERENCE® has the same shelf life . - . REFERENCE® is manufactured using the same materials and processes In summary, ESPE's new composite restorative material REFERENCE® described in this submission is, in our opinion, substantially equivalent to the predicate device. The substantial equivalence to the well established PERTAC® II, the performance data and the results of biocompatibility testing provide evidence that safety and effectiveness requirements of REFERENCE® are completely met. Image /page/1/Picture/13 description: The image shows the logo for 510(k) REFERENCE. The logo has the text "510(k) REFERENCE" on the top line, with a registered trademark symbol to the right of the word REFERENCE. Below the text is a logo with a tree on the left and the word "ESPE" on the right. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its body and wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 7 1999 Dr. Andreas Petermann Requlatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld Bavaria, Germany Re : K992966 Trade Name: REFERENCE® Regulatory Class: II Product Code: EBF Dated: August 31, 1999 Received: September 2, 1999 Dear Dr. Petermann: 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬ 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 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 {3}------------------------------------------------ #### Page 2 - Dr. Petermann 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 debering 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 oremarket 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.fja.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## STATEMENT OF INDICATIONS FOR USE Device Name: III. REFERENCE® Indications for use: Composite restorative material for: Restorations of type I, II, III, IV, and V cavities (according to Black) Fillings in deciduous teeth Extended fissure sealing Cervical erosions and abrasions Cutting edge build-up Repairing of veneers made of composite and ceramics Inlays fabrication Interlocking of loose teeth Prescription Use (Per 21 CFR 801.109) Susan Runner (Division Sign-Off Division of Organ Langson ::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: and General Hostital Desi 510(k) Number Image /page/4/Picture/16 description: The image shows the text "510(k) REFERENCE" in the top left corner. Below this text is a logo that appears to be a tree. To the right of the tree logo is the word "ESPE" in large, bold letters. The text and logo are all in black and white.