IMPREGUM PENTA DUOSOFT

{0}------------------------------------------------ # 9 × # JAN 2 8 2000 ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IV. ## Submitter | Company: | | |---------------------------------------------|--------------------------------| | Street: | | | ZIP-Code, City: | | | Federal State: | | | Country: | | | Establishment Reqistration Number: 9611385 | | | | Contact:<br>Regulatory Affairs | | Phone: | | | Fax: | | | E-mail | | | Date: | | | Name of Device | | | Proprietary Name: | IMPREGUM® PENTA® H DUOSOFT | | Classification Name: | | | | Common Name: | | Predicate Device | | | PERMADYNE® PENTA® | | | Description for the Premarket Notification | | IMPREGUM® PENTA® DUOSOFT is classified as an impression material (21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth. Special 510(k) IMPREGUM® PENTA® DUOSOFT · {1}------------------------------------------------ - IMPREGUM® PENTA® DUOSOFT is manufactured and packaged using the same materials and processes All chemical components of IMPREGUM® PENTA® DUOSOFT are already part of the predicate device PERMADYNE® PENTA® or are contained in other 510(k) cleared impression materials manufactured by ESPE. Therefore, we believe that additional biocompatibility testing is not required. In summary the modified IMPREGUM® PENTA® DUOSOFT described in this submission is, in our opinion, substantially equivalent to the predicate device. Image /page/1/Picture/3 description: The image shows the text "Special 510(k) IMPREGUM® PENTA® DUOSOFT" above a logo. The logo is a square with a tree inside of it, and the word "ESPE" is to the right of the square. The text and logo are all in black. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT FOR HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services. Public Health Service JAN 2 8 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Dr. Andreas Petermann Manager, U.S. Regulatory Affairs ESPE Dental AG - ESPE Platz D-82229 Seefeld, Bavaria, Germany Re : K994193 Imprequm® Penta® DuoSoft Trade Name: Requlatory Class: II Product Code: ELW Dated: December 10, 1999 Received: December 13, 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 qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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. 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 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 asboirson 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, 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 D. Device Name: IMPREGUM® PENTA® H DUOSOFT IMPREGUM® PENTA® L DUOSOFT Indications for use: Dental impression material for automatic mixing and dispensing in a PENTAMIX® or PENTAMIX® 2 mixing device, resp .: Impressions for inlay, onlay, crown, and bridge restorations Functional impressions Fixation impressions Implant impressions Susan Runner (Division Sign-Off) ision of Dental, Infection Control · General Hospital Devices (k) Number 1994 9 Image /page/4/Picture/12 description: The image shows the text "Special 510(k) IMPREGUM® PENTA® DUOSOFT" in a bold, sans-serif font. Below this text is the logo for ESPE, which includes a stylized image of leaves within a square border. The text and logo are aligned to the left side of the image. Prescription Use (Per 21 CFR 801.109) Page 25 of 60