FLUORCANASITE DENTAL CERAMIC

{0}------------------------------------------------ K100794 # SECTION 5 - 510(k) Summary JAN 2 5 2011 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92 APPLICANT: Dr. Sarah Pollington ADDRESS: Redbank, Ashopton Road, Bamford, Hope Valley, Derbyshire, S33 0AZ UK PHONE: +44 (0) 1433 65 1541 CONTACT PERSON: Dr. Sarah Pollington OFFICIAL CORRESPONDENT: Ms. Judy Burton, Advena Ltd. ADDRESS OF CORRESPONDENT: 3010 Valley View Lane, 12th Floor, Dallas, Texas 75234 CORRESPONDENT PHONE: (972) 243-5105 CORRESPONDENT FAX: (972) 243-1542 DATE OF SUMMARY: November 19, 2010 TRADE NAME: Fluorcanasite Dental Ceramic COMMON NAME: Dental Ceramic CLASSIFICATION NAME: Porcelein Powder for Clinical Use CLASSIFICATION CODE: EIH REGULATION NO .: 872.6660 PREDICATE DEVICE: K051705 IPS E. Max CAD CLASSIFICATION CODE: EIH REGULATION NO.: 872.6660 {1}------------------------------------------------ DEVICE DESCRIPTION: Fluorcanasite is a CAD/CAM machinable glass ceramic block, batched from standard glass-making ingredients which are intended to be used by trained professionals in a dentist's office for the manufacture of all-ceramic inlays, onlays, crowns, and veneers. #### DEVICE COMPARISON: | | New Device | Predicate Device | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | | K051705 | | Device Name, Model | Fluorcanasite | IPS e. max CAD<br>(lithium disilicate) | | Manufacturer | Dr. Sarah Pollington | Ivoclar Vivadent, Inc. | | Intended Use | A ceramic material to be<br>used for machining into tooth<br>cores that are then veneered<br>and secured by a specific<br>adhesive to the dentine of a<br>patient's modified and<br>prepared tooth. | IPS e. max CAD is a CAD/CAM<br>machinable glass ceramic<br>based on lithium disilicate for<br>the preparation of full ceramic<br>crowns, inlays, onlays, and full<br>ceramic 3-unit anterior<br>bridges. | | Biaxial flexural strength | 271.3 MPa | 360 MPa | | CTE | 8.8 ppm/°C | 10.45 ppm/°C | | Chemical solubility | 722 ug/cm² | 30-50 ug/cm² | | Fracture toughness | 4.2 MPa m1/2 | 2.0-2.5 MPa m1/2 | | Hardness | 5.18 GPa | 5.94 GPa | | MTBS (ceramic composite) | 27.59 MPa | n/a | INTENDED USE: Fluorcanasite is a CAD/CAM machinable glass ceramic block, batched from standard glass-making ingredients which are intended to be used by trained professionals in a dentist's office for the manufacture of all-ceramic inlays, onlays, crowns, and veneers. TECHNOLOGICAL CHARACTERISTICS: Fluorcanasite is a multiple chain-silicate glass-ceramic comprised of sodium carbonate, potassium carbonate, calcium carbonate, calcium fluoride, Loch Aline sand (high purity silica) and zirconia. Its properties display high strength and fracture toughness and the potential as an indirect resin-bonded dental restoration. CLINICAL TESTING: Non-clinical test data was used to support the devices safety and effectiveness. NON-CLINICAL TESTING: Fluorcanasite was subjected to the following non-clinical testing: - . ISO 6872:2008: Biaxial Flexural Strength, Fracture Toughness and Clinical Solubility; - . Vickers Hardness: Thermal Shock, Hardness and Brittleness Index, and Shelf Life; - ISO 10993-5: Biocompatibility; and, - . XRD and SEM - Crystalline Phase and Microstructural Analysis {2}------------------------------------------------ with the result that Fluorcanasite performed as well as, or better than, the predicate device. OTHER INFORMATION DEEMED NECESSARY BY FDA: A sample of dental restorative glass powder was analysed for uranium content. The results of the radiochemical analysis are tabulated on the following, with uncertainties quoted with a coverage factor of k=2, providing a level of confidence of approximately 95%. This work was managed under the NPL LRQA registration to ISO 9001:2000. Uranium was measured in this sample by initial dissolution in mineral acids, followed by ion exchange separation of uranium. The separated uranium was electrodeposited onto a stainless steel disc, which was then measured using a-particle spectrometry. Standardised 2320 was added as a chemical yield tracer for the analysis. | NPL identifier | Nuclide | Activity concentration | Mass concentration1 | |----------------|---------|------------------------|---------------------| | | | Bq/kg | μg/kg | | IM0900 | 234U | <8 | <0.035 | | | 235U | <1 | <0.51 | | | 238U | <1 | <6.5 | | | Total | <10 | <7.0 | #### CONCLUSION: The testing indicates that Fluorcanasite is safe and effective for its intended use and performs as well or better than the predicate device. {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is an abstract symbol that resembles three stylized human figures or waves. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Dr. Sarah Pollington C/O Ms. Judy Burton Advena Limited 3010 LBJ Freeway, 12th Floor Dallas, Texas 75234 JAN 2 5 2011 Re: K100794 Trade/Device Name: Fluorcanasite Dental Ceramic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 14, 2011 Received: January 21, 2011 Dear Ms. Burton: 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 (for 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. 1. . . . . {4}------------------------------------------------ Page 2- Ms. Burton Enclosure 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/MedicalDevices/Safety/ReportalProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Nh for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ ## SECTION 4 - Indications for Use Statement # Indications for Use 510(k) Number (if known): K100794 Device Name: Fluorcanasite Dental Ceramic Fluorcanasite is a CAD/CAM machinable glass ceramic block, batched from standard glassmaking ingredients which are intended to be used by trained professionals in a dentist's office for the manufacture of all-ceramic inlays, onlays, crowns, and veneers. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of *_*_ Susan Quare (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital Division of Anesthesion Devices Division of Antonio - Dental Devices 510(k) Number: 4-1