DCCERAM SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 28, 2015 Ceramay GmbH & Co. KG C/O Ms. Pamela Papineau, RAC President Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432 Re: K141400 Trade/Device Name: DCceram System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: October 30, 2014 Received: October 31, 2014 Dear Ms. Papineau: 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}------------------------------------------------ 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 contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K141400 Device Name DCceram System #### Indications for Use (Describe) The DCceram System is used to fabricate prostheses for missing/damaged teeth. The DCceram pressable ceramic ingots are pressed onto metal alloy (DCceram 12.5) or zirconia (DCceram 9.2) frames by dental technicians to fabricate ceramic restorations. DCceram 12.5 and DCceram 9.2 ceramic layering porcelains and shades are used to layer or build up the pressed ceramic to final tooth morphology and shade on the particular framework (DCceram 9.2 zirconia substructures; Deceram 12.5 metal substructures). The DCceram conceptPress ceramic ingots are used to fabricate all-ceramic restorations. DCceram concept Art ceramic stains and shades may be used with DCceram 9.2 ceramics. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995, *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Ceramay GmbH & Co. KG K141400/Amendment 1 July 14, 2014 DCceram System # Section 4: 510(k) Summary (revised) General Information Date Prepared: July 8, 2014 Owner's Name: Address: Telephone / Fax Number: Luitpoldstrasse11 D-89231 Neu-Ulm, Germany +49 731 93 80 777-0 Ceramay GmbH & Co. KG Contact Person: Pamela Papineau, RAC (US, EU, CAN) Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Aver, MA 01432 (978) 772-3552 (978) 796-5460 Telephone Number: Fax Number: # Subject Device: Trade Name: Common Name: Product Code: FDA Regulation: Device Classification: ## Predicate Devices: Product Name: Common Name: Product Code: FDA Regulation: Device Classification: Premarket Notification: Product Name: Common Name: Product Code: FDA Regulation: Device Classification: Premarket Notification: Product Name: Common Name: Product Code: FDA Regulation: Device Classification: Premarket Notification: DCceram System Dental Ceramic EIH 21 CFR 872.6660 - Porcelain Powder for Clinical Use Class II In-Sync Ceramic System (Jensen Industries) Dental Ceramic EIH 21 CFR 872.6660 - Porcelain Powder for Clinical Use Class II K111743 Willi Geller Creation CP L&M Porcelain (Jensen Industrties) Dental Ceramic EIH 21 CFR 872.6660 - Porcelain Powder for Clinical Use Class II K002904 OPC 3G All-Ceramic System (Jeneric/Pentron) Dental Ceramic EIH 21 CFR 872.6660 - Porcelain Powder for Clinical Use Class II K994435 {4}------------------------------------------------ # Indications for Use The DCceram System is used to fabricate prostheses for missing/damaged teeth. The DCceram pressable ceramic ingots are pressed onto metal alloy (DCceram 12.5) or zirconia (DCceram 9.2) frames by dental technicians to fabricate ceramic restorations. DCceram 12.5 and DCceram 9.2 ceramic layering porcelains and shades are used to layer or build up the pressed ceramic to final tooth morphology and shade on the particular framework (DCceram 9.2 zirconia substructures; Dcceram 12.5 metal substructures). The DCceram conceptPress ceramic ingots are used to fabricate all-ceramic restorations. DCceram conceptArt ceramic stains and shades may be used with DCceram conceptPress or DCceram 9.2 ceramics. ## Device Description The DCceram System consists of several silica glass ceramic materials used to create ceramic and/or metal-ceramic dental prosthetic dental restorations, including inlays, onlays, veneers, crowns and bridges. The DCceram System components are available in a wide range of tooth shades (A1 – D4) as well as special shades. All DCceram System materials meet the physical properties requirements defined in ISO 6872:2008 Dentistry - Ceramic Materials, and are biocompatible as defined in ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry. The DCceram System components are: - DCceram 9.2 & 12.5 pressable porcelain ingots 0 - DCceram conceptPress porcelain ingots 0 - DCceram9.2 liner/layering porcelain 0 - DCceram 12.5 liner/layering porcelain o - DCceram12.5 stains and shades 0 - DCceram conceptArt stains, shades and glazes o The DCceram9.2 and 12.5 ingots are silicate glass-based ceramic materials designed to create dental restorations using a lost wax technique in a vacuum press. DCceram 9.2 ingots are used with zirconia frameworks; DCceram 12.5 is compatible with metal (dental alloy) frameworks. The DCceram conceptPress ingots are used to create all-ceramic dental restorations. The complete DCceram System also includes a full line of compatible liner, build-up, layering and veneering ceramics. All system materials are available in a range of tooth shades. #### Substantial Equivalence The DCceram System is substantially equivalent to the Jensen Dental InSync Ceramic System (K111743), which is comprised of a full range of pressable, silica-based ceramic pellets and compatible layering porcelains used with zirconia and metal alloy frameworks, the Willi Geller CP L&M Porcelain (K002904), which is used with metal alloy frameworks, and to the Jeneric/Pentron OPC 3G All-Ceramic System (K994435), which includes pressable silica-based pellets and compatible layering porcelains used to create all-ceramic restorations. Substantial equivalence is based on indications for use, technological characteristics, material composition, usage techniques and conformity with consensus standards. # Testing This 510(k) includes the results of performance testing to support compliance with ISO 6872:2008; these tests included coefficient of thermal expansion, transformation temperature, bending strength, chemical solubility and radioactivity for the DCceram System materials that are considered Type I or Type II, Class 1a materials per ISO 6872:2008. The DCceram conceptPress porcelain ingots are a Type II, Class 4b material per ISO 6872; testing for this system component consisted of coefficient of thermal expansion, transformation temperature, {5}------------------------------------------------ bending strength, Weibull strength/modulus, fracture toughness, Martens hardness, chemical solubility and radioactivity. All DCceram System components met the minimum performance testing requirements specified in ISO 6872; where applicable (CTE, transformation temperature) the performance testing data has been incorporated into the device labelling. The DCceram System materials were evaluated for biocompatibility in accordance with ISO 7405 and ISO 10993-5. This 510(k) includes the results of ISO 10993-5 cytotoxicity testing, which demonstrated that the DCceram System components are non-cytotoxic. ## Conclusion The DCceram System has been demonstrated to be substantially equivalent to the predicate devices.