PENTAMIX 2

{0}------------------------------------------------ #### ll. ## 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: | June 1, 1999 | #### Name of Device | Proprietary Name: | PENTAMIX® 2 | |----------------------|----------------------------------------------------------------| | Classification Name: | Amalgamator, Dental, AC-Powered | | Common Name: | Automatic mixing device for ESPE PENTA<br>impression materials | ### Predicate Device CAPMIX® by ESPE .............................................................................................................................................................. #### Description for the Premarket Notification ESPE's new mixing device for impression materials, PENTAMIX® 2, is comparable and substantially equivalent to an AC-powered dental amalgamator. It is therefore a class I device which has been exempted from premarket notification requirements (21 C.F.R. § 872.3100). However, consistent with 21 C.F.R. § 872.9, ESPE is submitting this premarket notification because the intended use of РЕ№ТАМІХ® 2 is significant different to that of САРМХ® (21 С.F.R. § 872.9 a). Furthermore, ESPE wants to give evidence that safety and effectiveness are only warranted when Image /page/0/Picture/12 description: The image shows the text "510(k) PENTAMIX 2" on the top line. Below that is a logo of a tree inside of a square. The word "ESPE" is on the bottom line in large, bold letters. The image appears to be a logo or label for a product. {1}------------------------------------------------ PENTAMIX® 2 is used together with ESPE's especially designed PENTA impression materials. Since 1993, ESPE has been marketing the predecessor of PENTAMIX® 2, PENTAMIX®, successfully all over the world. The high level of acceptance, together with permanent contact between ESPE and its customers, led first of all to an expansion of the PENTA product family. However, through this dialogue, ESPE also became aware that many users wanted a faster working mixing unit. This wish has now been met with PENTAMIX® 2. The predecessor of PENTAMIX® 2, PENTAMIX® was determined by ESPE to be substantially equivalent to a mixing spatula/mixing bowl, and, therefore did not go through the 510(k) process. However, the PENTAMIX® device was reviewed by the FDA in connection with ESPE's 510(k) submissions for its PENTA impression materials PERMADYNE® PENTA (K 953027), RAMITEC® PENTA (K 952693), IMPREGUM® PENTA (K954192), DIMENSION® PENTA (K 960547), and POSITION® PENTA (K 974231). We are aware of the fact that the PENTAMX® 2 could be marketed without 510(k) clearance in the U.S.A. With this 510(k) submission we want to focus on the PENTAMIX® 2 system to claim, that safe handling and satisfying results for patient and user are only ensured when PENTAMIX® 2 is used together with genuine ESPE PENTA impression materials, The basis for our substantial equivalence determination will be the PENTAMIX® which is a well-established, safe and effective medical device. Technical and performance data of the two PENTAMIX® devices will be compared to show that ESPE's further development PENTAMIX® 2 is as safe and effective as its predecessor. The predicate device CAPMIX® is used to provide a regulation number and a product code. PENTA impression materials are provided in so called poly bags. Those have to be inserted in especially designed cartridges which ensure correct and simple handling of the materials with РЕ№ТАМІХ . In recent time, ESPE recognized that competitors copied the poly bags and sold those materials for the use with ESPE's PENTAMIX . Due to the fact that there is no corresponding cartridge and to different Image /page/1/Picture/6 description: The image shows the text "510(k) PENTAMIX® 2" above the letters "ESPE" in a large font. To the left of the letters ESPE is a logo of a tree inside of a square. The text and logo are all in black and white. {2}------------------------------------------------ material characteristics, safety and effectiveness of the impression materials for the patient and user are not warranted in ESPE's point of view. For patient and user safety features, ESPE is submitting this premarket notification to emphasize that safety and effectiveness of the impression process is only guaranteed when genuine PENTA materials are used with PENTAMIX® 2. PENTAMIX® 2, as successor to PENTAMIX®, offers the same simple and convenient handling at 1.5 times the speed. The accustomed high mixing quality of impression materials remains unchanged. The higher dispensing speed achieved is, however, a significant safety factor in terms of working time for all indications, and equally represents a clear time saving. The PENTAMIX® 2 system permits more relaxed and cost-effective work, and is intended as another step towards greater precision. Image /page/2/Picture/3 description: The image shows the text "510(k) PENTAMIX 2 ESPE". The text is in black and is on a white background. There is a logo to the left of the text that looks like a tree. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 26 1999 Dr. Andreas Petermann Regulatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld Bavaria, Germany Re : K991913 Trade Name: Pentamix® 2 Requlatory Class: I Product Code: EFD Dated: June 1, 1999 Received: June 7, 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 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. A 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. {4}------------------------------------------------ Page 2 - Dr. Petermann 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 findinq 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 Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # ાં ર #### STATEMENT OF INDICATIONS FOR USE lll. Device Name: Pentamix® 2 Indications for use: Automatic mixing, dosing and dispensing system for ESPE's PENTA impression and bite registration materials: - IMPREGUM® PENTA . - Permadyne® Penta H . - Permadyne® Penta L . - Ramitec® Penta . - DIMENSION® PENTA H . - DIMENSION® PENTA H QUICK . - DIMENSION® PENTA L . - POSITION® PENTA . - Position® Penta Quick . Susan Range (Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 510(k) Number Image /page/5/Picture/17 description: The image shows the text "510(k) PENTAMIX® 2" in a bold, sans-serif font. Below this text is a logo that includes a stylized image of a plant or tree within a square border. To the right of the logo, the word "ESPE" is printed in a large, bold font, completing the visual elements of the image.