IONOLUX

{0}------------------------------------------------ K09 0817 ## 510(k) SUMMARY Contact: Manfred Th. Plaumann JUL 2 8 2009 Date prepared: March 24th, 2009 Trade or proprietary name: lonolux Classification name: Cement, Dental (872.3275) Predicate device: GC Fuji II LC improved (K961584, GC America, Inc.) Device description: Ionolux is a resin-reinforced radiopaque light-curing glass-polyalkenoate restorative. The material has outstanding aesthetics, good handling properties and high chemical adhesion. ## Intended use: lonolux is intended for the following applications: - 1. Restorations class III and V, especially cervical fillings and root caries - 2. Fillings on deciduous teeth - 3. Small class I fillings - 4. Temporary fillings - 5. Core build-up - 6. Lining Technological characteristics: All of the components of Ionolux are found in the legally marketed device GC Fuji II LC improved (K961584, GC America, Inc.) The prior use of all of the components of Ionolux in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional blocompatibility studies with the final formulation are not necessary. We believe that the prio use of the components of lonolux in legally marketed devices and the performance data and results provided support the safety and effectiveness of lonolux for the intended use. VOCO GmbH, March 24th, 2009 Manfred Th. Plaumann GMBH Managing Boar {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of flowing lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ాళ్ల స Mr. M. Th. Plaumann VOCO GmbH Anton- Flettner- Strasse 1-3 Cuxhaven Germany D-27472 JUL 23 2009 Re: K090817 Trade/Device Name: IONOLUX Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class; II Product Code: EMA Dated: July 9, 2009 Received: July 14, 2009 Dear Mr. Plaumann: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent ffor the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ ## Page 2- Mr. Plaumann Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies, You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Susan Runner Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Statement 510(k) Number: K090817 Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use: lonolux is intended for the following applications: - 1. Restorations class III and V, especially cervical fillings and root caries - - 2. Fillings on deciduous teeth - 3. Small class I fillings - 4. Temporary fillings - 5. Core build-up - 6. Lining Prescription Use OR Over-The-Counter Use (Please do not write Below this line-continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Kerin Mily for MSR (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K090817