n!ce Glass Ceramic Blocks for Amann Girrbach

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is often associated with medicine and healthcare. The caduceus is composed of three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 2, 2017 Institut Straumann AG % Jennifer Jackson Director of Regulatory Affairs and Ouality Straumann USA. LLC 60 Minuteman Road Andover, Massachusetts 01810 Re: K170420 Trade/Device Name: N!ce Glass Ceramic Blocks For Amann Girrbach Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: February 9, 2017 Received: February 13, 2017 Dear Jennifer Jackson: 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. 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Susan Runno DDS, MA For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) Device Name Straumann n!ce Blocks for Amann Girrbach Indications for Use (Describe) Once finalized into a suitable design, the n!ce™ glass-ceramic blocks are indicated for use as inlays, onlays, veneers, partial crowns and crowns. 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ - Submitter: Straumann USA, LLC (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 Jennifer M. Jackson, MS Contact Person: Head of Regulatory Affairs and Quality Straumann USA Prepared By Christopher Klaczyk & Secondary Head of Regulatory Affairs & Compliance Contact: Institut Straumann AG Date Prepared: February 9, 2017 EIH (21 CFR 872.6660) Product Code(s): II (21 CFR 872.6660) Device Class: Classification Panel: Dental Classification Name: Powder, porcelain for clinical use (21 CFR 872.6660) Straumann® n!ce™ Blocks for Amann Girrbach Proprietary Name: K160262. Straumann® n!ce™ Glass Ceramic Blocks (Institut Predicate Device:: Straumann AG) Reference Device(s): None Straumann® n!ce™ glass ceramic is a proprietary lithium Device Description: disilicate (Li2O-SiO2) glass ceramic material intended to be milled to produce prosthetic restorations for natural and endosseous dental implant abutment borne teeth. The material is suitable for use in inlays, onlays, veneers, copings and monolithic crown restorations. The mandrel bonded to the blocks is compatible with Amann Girrbach milling equipment. Intended Use: The n!ce™ glass ceramic is intended to be used to manufacture ceramic prostheses for the restoration of natural teeth or on top of abutments. ട. 510(k) Summary {4}------------------------------------------------ | <b>Indications For Use:</b> | Once finalized into a suitable design, the n!ce™ Glass-Ceramic Blocks are indicated for use as inlays, onlays, veneers, partial crowns and crowns. | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| Technological A comparison of the relevant technological characteristics Characteristics: between the subject and primary predicate devices is provided in the table that follows. | Feature | Subject Device<br>n!ce Blocks for Amann Girrbach | Primary Predicate Devices<br>Straumann n!ce Glass Ceramic Blocks<br>(K160262) | |--------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | Block Chemical<br>Composition | lithium disilicate – lithium aluminosilicate glass | | | Crystallization<br>State as Supplied | Fully crystallized | | | Esthetic<br>Characteristics | Translucency: | High Translucency (HT)<br>Low Translucency (LT) | | | Shades: | HT/LT: 6 A-D | | | Color Uniformity: | Homogenous | | | Fluorescence: | Present | | Block Dimensions | C14 (12.4 x 14.5 x 18.0 mm) | | | Mandrel Design | The mandrel is compatible with material<br>holders of Amann Girrbach mills. | The mandrel is compatible with material<br>holders of Sirona CEREC<br>and inLab mills and other third-party mills. | | Mandrel Material | AlMgSiSn Alloy with Alodine 1500 anti-<br>corrosive coating | AlSi1Sn1MgBi Alloy | | Minimum Wall<br>Thickness | 1.0 mm | | | Flexural Strength | Meets ISO 6872 requirements for a Type II, Class 2 dental ceramic material. | | | Radioactivity | Meets ISO 6872 requirements for a Type II, Class 2 dental ceramic material | | | Chemical Solubility | Meets ISO 6872 requirements for a Type II, Class 2 dental ceramic material. | | | Coefficient of<br>Thermal Expansion<br>(CTE) 100-500°C | HT: | $7.1 x 10^6/K$ | | | LT: | $7.2 x 10^6/K$ | | Glass Transition<br>Temperature (Tg) | HT: | 497°C | | | LT: | 491°C | {5}------------------------------------------------ | Performance Data: | Test data to support the evaluation of the subject n!ce™ Glass-<br>Ceramic Blocks has been submitted or included by reference as follows:<br>Product performance testing per ISO 6872, Dentistry—<br>Ceramic materials ISO 7991, Glass—Determination of coefficient of mean<br>linear thermal expansion. Biocompatibility assessment as follows: Evaluation per ISO 10993-1, Biological evaluation of<br>medical devices — Part 1: Evaluation and testing within<br>a risk management process. Cytotoxicity assessment per ISO 10993-5, Biological<br>evaluation of medical devices — Part 5: Tests for in<br>vitro cytotoxicity. Chemical characterization per ISO 10993-18, Biological<br>evaluation of medical devices—Part 18: Chemical<br>characterization of materials. Transport and package testing per ISTA 2A and the<br>standards referenced therein. Evaluation of shelf life per ASTM F1980, Standard Guide<br>for Accelerated Aging of Sterile Barrier Systems for<br>Medical Devices. | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusions: | Based upon our assessment of the design and applicable<br>performance data, the subject devices have been determined to<br>be substantially equivalent to the identified predicate devices. |