GRANDIO SO HEAVY FLOW

{0}------------------------------------------------ 102354 ### 510(k) SUMMARY re | Contact: | M. Th. Plaumann | | |----------------------------|----------------------------------------------------------------------|------------| | Date prepared: | August 16, 2010 | NOV - 8 20 | | Trade or proprietary name: | Grandio SO Heavy Flow | | | Classification name: | Material, Tooth Shade, Resin (872.3690) | | | Predicate device: | Grandio Flow, K051868, VOCO GmbH<br>Grandio Flow, K101213, VOCO GmbH | | ### Device description: Grandio SO Heavy Flow is a steady but shear thinning, methacrylate based dental filling composite for all cavity classes with increased inorganic filler content and excellent physical properties e.g. wear resistance, compressive strength, color stability in the mouth compared with other flow composites. Grandio SO Heavy Flow comes in different tooth like shades of optimal opacity and can be easily polished. It is therefore highly qualified for long lasting esthetic restorations. Grandio SO Heavy Flow is processed according to current state of the art procedures for light curing flowable dental composites, thus, Grandio SO Heavy Flow can be applied by any dental professional who is familiar with this kind of materials. Like the predicate device Grandio Flow it can easily be placed and processed prior to curing and finishing. ## Intended use: Grandio SO Heavy Flow is intended for use as: - filling minimally invasive cavities of all classes - - filling small class I cavities and extended fissure sealing - - filling class II - V cavities including V-shaped defects and cervical caries - blocking out undercuts - - lining or coating cavities - repairing fillings and veneers - luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.) - ### Technological characteristics: Grandio SO Heavy Flow and the legally marketed device Grandio Flow, K051868 (VOCO GmbH) share the same indications but have improved physical features. Grandio SO Heavy Flow has been optimized with regard to several physical parameters. Grandio SO Heavy Flow based on nanohybrid technology just like the predicate device Grandio Flow. This technology relies on the optimization of the mixing ratio of inorqanic filler particles in different sizes. The components of Grandio SO Heavy Flow serve the same purpose as the ingredients of the predicate device Grandio Flow. The prior use of all of the components of Grandio SO Heavy Flow in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary. {1}------------------------------------------------ We believe that the prior use of the components of Grandio SO Heavy Flow in legally marketed devices and the performance data and results also provide support for the safety and effectiveness of Grandio SO Heavy Flow for the intended use. VOCO GmbH, September 6th, 2010 Dr. Thorsten Gerkensmeier (Regulatory Affairs) ﺔ، ﻭ a {2}------------------------------------------------ #### Device Description and Executive Summary Grandio SO Heavy Flow is a stready but shear thinning, methacrylate based dental filling composite for all cavity classes with increased inorganic filler content and excellent physical properties e.g. wear resistance, compressive strength, color stability in the mouth compared with other flow composites. Grandio SO Heavy Flow comes in different tooth like shades of optimal opacity and can be easily polished. It is therefore highly qualified for long lasting esthetic restorations. Grandio SO Heavy Flow is processed according to current state of the art procedures for light curing flowable dental composites, thus, Grandio SO Heavy Flow can be applied by any dental professional who is familiar with this kind of materials. Like the predicate device Grandio Flow it can easily be placed and processed prior to curing and finishing. Grandio SO Heavy Flow will be offered in the following presentations: - , syringes of 2g - -Caps of 0.25g Grandio SO Heavy Flow is intended for use as: - filling minimally invasive cavities of all classes । - + filling small class I cavities and extended fissure sealing - filling class II V cavities including V-shaped defects and cervical caries - - blocking out undercuts - lining or coating cavities - - repairing fillings and veneers - luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.) Grandio SO Heavy Flow is claimed to be substantially equivalent to Grandio Flow. K051868, K101213 (VOCO GmbH) For details of product performance data please section 9 (substantial equivalence comparison). {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned above a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, framing the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Manfred T. Plaumann Voco GmbH Anton-Flettner-Strasse 1-3 Cuxhaven Germany D-27472 NOV - 8 2010 Re: K102354 Trade/Device Name: Grandio SO Heavy Flow Regulation Number: 21 CFR 872,3690 Regulatory Class: II Product Code: EBF Dated: October 13, 2010 Received: October 15, 2010 Dear Mr. Plaumann: We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendrers or to devices that have been reclassified in accordance with the provisions of the Federal Food, 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 affer innuncu 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) regulation (21 CFR Part 820) and that, through periodic GMP investions, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 obligation you might have under secions 5 1 through 542 of the Act for devices under the Electronic Product Radiation Control neversisens, or other Federal laws or regulations. {4}------------------------------------------------ Page 2 – Mr. Manfred T. Plaumann This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. 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 (240) 276-6649. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (240) 276-3150. Sincerely yours Susanner · Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ # Indications for Use Statement 510(k) Number: K 102354 Grandio SO Heavy Flow _ Device Name: Indications for Use: Grandio SO Heavy Flow is intended for use as: - filling minimally invasive cavities of all classes - - filling small class I cavities and extended fissure sealing - - filling class II V cavities including V-shaped defects and cervical caries - - blocking out undercuts - - lining or coating cavities - - repairing fillings and veneers - - luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.) - Prescription Use _ X 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) Suza Runner (Division Sign-Off) (Division Sign-On) Division of Anesthesiology, General Hospital Clivision of Anesthesiology, General Boxiness Infection Control, Dental Devices 510(k) Number: K102354