VESTOGUM

{0}------------------------------------------------ II. ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS #### 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, Regulatory Affairs | | Phone: | 011-49-8152-7001395 | | Fax: | 011-49-8152-7001869 | | E-mail: | Andreas_Petermann@ESPE.de | | Date: | April 8, 1999 | #### Name of Device | Proprietary Name: | VESTOGUM® | |----------------------|---------------------------| | Classification Name: | Impression Material | | Common Name: | Gingiva Modeling Material | #### Predicate Device IMPREGUM® PENTA by ESPE……………………….K 954192 PERMADYNE® PENTA H by ESPE ................... K 953027 ### Description for the Premarket Notification VESTOGUM® is classified as a dental impression material (21 C.F.R. § 872.3660) because it is a device intended to be one step in the process to reproduce the structure of a patient's gums. VESTOGUM® serves for making a gingiva model. Because of exposing the preparation border on the master cast, there is an essential lack of information with regard to the impressed soft tissues. The gingiva modeling material on polyether basis, in color adapted to the natural gingiva, is a controlling material in order to avoid a displacement of the marginal Image /page/0/Picture/13 description: The image shows the text "510(k) VESTOGUM" in the top left corner, with a registered trademark symbol next to it. Below the text is a logo that includes a tree and the word "ESPE" in bold letters. The logo is black and white and appears to be for a product or company called VESTOGUM. {1}------------------------------------------------ periodontium due to overcontuored crowns. VESTOGUM® thus contributes considerably to a periodontally hygienic functional and esthetic prosthesis. VESTOGUM® consists of the same ingredients as IMPREGUM® PENTA, ESPE's proven and well-established polyether based impression material except one pigment. This pigment, however, is contained in ESPE's polyether based impression material PERMADYNE® PENTA H. The fact that no new ingredients are contained ensures in our opinion that no new toxicology and biocompatibility studies are necessary. ESPE has long marketing experience with polyether based impression materials. IMPREGUM® F, which is the hand-mixed version of IMPREGUM® PENTA is marketed in the U.S.A. since 1986, the hand-mixed PERMADYNE® impression materials since 1980. In European countries, VESTOGUM® is successfully marketed for more than 10 years. In our opinion the marketing experience with VESTOGUM®, the substantial equivalence of VESTOGUM® to the predicate devices IMPREGUM® and PERMADYNE® with long marketing history and clinical experience, and the performance data support the safety and effectiveness of VESTOGUM® for the intended use. Image /page/1/Picture/3 description: The image contains the text "510(k) VESTOGUM" at the top. Below the text is a logo that contains a tree inside of a square. To the right of the logo is the word "ESPE" in large, bold letters. {2}------------------------------------------------ Public Health Service Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters. MAY 20 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Dr. Andreas Petermann, Requlatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld Bavaria, Germany K991221 Re : Trade Name: VESTOGUM® II Requlatory Class: Product Code: ELW Dated: April 8, 1999 April 12, 1999 Received: 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಗ 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 - Dr. Petermann this response to your premarket notification Please note: submission does not affect any obliqation you miqht 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, 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}------------------------------------------------ # 991221 # STATEMENT OF INDICATIONS FOR USE | Device Name: | VESTOGUM® | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use: | Gingiva Modeling Material for: | | | Combination works<br>when choosing and mounting the attachment,<br>the papilla is fully preserved | | | Telescopic works<br>the shoulder of the crowns to be cut is indicated<br>according to the gingiva contour | | | Anterior tooth area<br>with regard to esthetics and periodontal<br>hygienics, the forming possibilities of the<br>interdental spaces are increased | | | Forming of different tooth lengths<br>according to the natural conditions in the<br>patient's mouth, they can be adapted in<br>anatomically correct way; especially in bridge<br>spans | | | Color rating of the veneer material<br>the material which is in color adapted to the<br>gingiva, serves for more precise color matching | | | Controlled modellation<br>the cervical-incisal crown convexity for the<br>protection of the gingival margin can be<br>controlled | | Prescription use:☒ | Over-the counter use ☐ | (Division Sign-Off) Division of Dental, Infection Control, and General Hoonitel Devise Division of Dental, Infection Control and General Hospital, Devices 510(k) Number ____________________________________________________________________________________________