← Product Code [NHA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA) · K171773 # Straumann n!ce Glass Ceramic A14 Blocks (K171773) _Institut Straumann AG · NHA · Dec 1, 2017 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K171773 ## Device Facts - **Applicant:** Institut Straumann AG - **Product Code:** [NHA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA.md) - **Decision Date:** Dec 1, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3630 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use The Straumann n!ce Glass Ceramic A14 Blocks are intended to be ceramic mesostructures cemented to the Ti-base for a two-piece hybrid abutment for single tooth restorations or hybrid abutment crowns, used in conjunction with endosseous dental implant to restore chewing function. The following compatibilities apply: Ti-Base manufacturer system Reference Block interface size Straumann RC Variobase® for CEREC 022.0024 L NC Variobase® for CEREC 022.0025 L RN Variobase® for CEREC 022.0019 L WN Variobase® for CEREC 022.0020 L ## Device Story Straumann n!ce Glass Ceramic A14 blocks consist of lithium disilicate-reinforced lithium aluminosilicate glass-ceramic. Blocks feature a pre-milled interface for Straumann Variobase Ti-bases. Trained professionals use Sirona inLab (v3.65) or CEREC (v4.2) software to design mesostructures; milling occurs on Sirona CEREC or inLab MC X/XL systems. Final restorations are cemented to Ti-bases to form two-piece hybrid abutments or crowns. Used in dental clinics to restore chewing function in patients with endosseous implants. Benefits include patient-specific prosthetic fit and restoration of masticatory function. ## Clinical Evidence Bench testing only. Evidence includes product performance testing per ISO 6872 (dentistry-ceramic materials) and ISO 14801 (dynamic fatigue for implants). Biocompatibility assessed per ISO 10993 series. Chemical characterization performed per ISO 10993-18. Shelf life validated per ASTM F1980. Steam sterilization validated per ISO 17665. Workflow and machinability validated for Sirona milling systems. ## Technological Characteristics Material: Lithium disilicate-reinforced lithium aluminosilicate glass-ceramic. Form factor: A14 blocks (12.4 x 14.5 x 18.0 mm) with pre-milled interface. Energy source: Mechanical milling. Connectivity: Compatible with Sirona CEREC/inLab CAD/CAM software and milling units. Sterilization: Steam sterilization (ISO 17665). ## Regulatory Identification An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. ## Special Controls *Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.) ## Predicate Devices - IPS e.max CAD Abutment Solutions ([K132209](/device/K132209.md)) ## Reference Devices - n!ce Glass Ceramic Blocks ([K160262](/device/K160262.md)) - Variobase® for CEREC® ([K151324](/device/K151324.md)) - Variobase® with n!ce™ Restorations ([K170354](/device/K170354.md)) ## Related Devices - [K132209](/device/K132209.md) — IPS E.MAX CAD ABUTMENT SOLUTIONS · Ivoclar Vivadent, AG · Oct 31, 2013 - [K160262](/device/K160262.md) — n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, · Institut Straumann AG · Sep 16, 2016 - [K222836](/device/K222836.md) — Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs · Institut Straumann AG · May 15, 2023 - [K153130](/device/K153130.md) — Initial LiSi Block · GC America, Inc. · Sep 13, 2016 - [K252248](/device/K252248.md) — CEREC Tessera Abutment System · Dentsply Sirona · Nov 26, 2025 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 1, 2017 Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs and Quality Straumann USA. LLC 60 Minuteman Road Andover, Massachusetts 01810 Re: K171773 Trade/Device Name: Straumann® n!ce Glass Ceramic A14 Blocks Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 2, 2017 Received: November 3, 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Andrew I. Steen -S 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 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K171773 Device Name Straumann n!ce Glass-Ceramic A14 Blocks The Straumann n!ce Glass Ceramic A14 Blocks are intended to be ceramic Indications for Use (Describe) mesostructures cemented to the Ti-base for a two-piece hybrid abutment for single tooth restorations or hybrid abutment crowns, used in conjunction with endosseous dental implant to restore chewing function. The following compatibilities apply: | Ti-Base | | | Block | |--------------|-------------------------|-----------|----------------| | manufacturer | system | Reference | interface size | | Straumann | RC Variobase® for CEREC | 022.0024 | L | | | NC Variobase® for CEREC | 022.0025 | L | | | RN Variobase® for CEREC | 022.0019 | L | | | WN Variobase® for CEREC | 022.0020 | L | 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. 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." Page 1 of 1 {3}------------------------------------------------ #### 1. 510(k) Summary | Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 9005052 | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jennifer Jackson, MS<br>Head of Regulatory Affairs and Quality<br>(978) 747-2509 | | Prepared By: | Shokoufeh Khodabandeh<br>Regulatory Affairs and Compliance Manager<br>Institut Straumann AG<br>+41 61 965 1260 | | Date Prepared: | December 1, 2017 | | Product Code(s): | NHA (21 CFR 872.3630) | | Device Class: | II (21 CFR 872.3630) | | Classification Panel: | Dental | | Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) | | Proprietary Name: | Straumann® n!ce Glass Ceramic A14 Blocks. | | Predicate Device: | K132209 IPS e.max CAD Abutment Solutions ( Ivoclar<br>Vivadent, Inc.) | | Reference Device(s): | K160262 n!ce Glass Ceramic Blocks ( Institut Straumann AG)<br>K151324, Variobase® for CEREC® (Institut Straumann AG)<br>K170354, Variobase® with n!ce™ Restorations (Institut<br>Straumann AG) | | Device Description: | Straumann® n!ce® glass ceramic is a proprietary lithium<br>disilicate (Li2O-SiO2) dental glass ceramic material. The n!ce®<br>glass-ceramic A14 blocks feature a pre milled interface that fits<br>the Straumann® Variobase® for CEREC®. The blocks are<br>further processed by the trained professional to make<br>individually designed mesostructure that are milled into the<br>desired shape of a hybrid abutment or hybrid abutment crown<br>using the Sirona inLab (Version3.65) and CEREC® software<br>(Version 4.2). n!ce® mesostructures can be | {4}------------------------------------------------ additional crystallization firing. Stain & glaze techniques can be applied. n!ce® A14 blocks are available in two levels of translucency: HT (High Translucency) and LT (Low Translucency). Both translucencies are available in shades , A1, A2, A3, B2, B4 and C2 for flexibility and application variety to meet individual patient needs. n!ce®A14 blocks are available with one interface size large (L)" The n!ce glass-ceramic A14 blocks are intended to be used to Intended Use: manufacture mesostructure cemented to Ti-Bases as part of a two-piece abutment or abutment crown, which are placed onto dental implants. Indications For Use: The Straumann n!ce Glass Ceramic A14 Blocks are intended to be ceramic mesostructures cemented to the Ti-base for a twopiece hybrid abutment for single tooth restoerations or hybrid abutment crowns, used in conjunction with endosseous dental implant to restore chewing function. The following compatibilities apply: | Ti-Base | | | Block | |--------------|-------------------------|-----------|----------------| | manufacturer | system | Reference | interface size | | Straumann | RC Variobase® for CEREC | 022.0024 | L | | | NC Variobase® for CEREC | 022.0025 | L | | | RN Variobase® for CEREC | 022.0019 | L | | | WN Variobase® for CEREC | 022.0020 | L | Materials: Lithium Disilicate reinforced Lithium Aluminosilicate Glass-Ceramic {5}------------------------------------------------ ## Technological Characteristics: A comparison of the relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows. | | Primary Predicate Device | Subject Devices<br>Straumann® n!ce Glass<br>Ceramic A14 Blocks | Equivalence<br>Discussion | | | | | | | | | | | | | | | | | | | | | |--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | IPS e.max CAD Abutment<br>Solutions (K132209) | | | | | | | | | | | | | | | | | | | | | | | | Indications For<br>Use | IPS e.max CAD Abutment<br>Solutions is intended for use in<br>partially or fully edentulous<br>mandibles and maxillae in support<br>of single cementretained<br>restorations. The system<br>comprises three parts: IPS e.max<br>CAD ceramic structure, Ti base<br>and CAD/CAM software. The IPS<br>e.max CAD ceramic structure<br>cemented to the Ti base is<br>recommended for two-piece<br>hybrid abutments for single tooth<br>restorations and hybrid abutment<br>crowns, used in conjunction with<br>endosseous dental implants. | The Straumann n!ce Glass<br>Ceramic A14 Blocks are<br>intended to be ceramic<br>mesostructures cemented to<br>the Ti-base for a two-piece<br>hybrid abutment for single<br>tooth restorations or hybrid<br>abutment crowns, used in<br>conjunction with endosseous<br>dental implant to restore<br>chewing function. The<br>following compatibilities<br>apply:<br>Ti-Base<br>manufacturer system Reference Block<br>interface size Straumann RC Variobase® for CEREC 022.0024 L NC Variobase® for CEREC 022.0025 L RN Variobase® for CEREC 022.0019 L WN Variobase® for CEREC 022.0020 L | | | | | | | | | | | | | | | | | | | | | Equivalent<br>The indications for the<br>n!ce Glass Ceramic A14<br>Blocks are within the<br>indications of the IPS<br>e.max CAD material.<br>The Compatibility to NC<br>and RC is covered<br>directly by the predicate<br>device.<br>Compatibility to WN and<br>RN is supported by the<br>reference device per<br>K151324, Variobase® for<br>CEREC® (Institut<br>Straumann AG) | | Block Dimensions | A14 (12.4 x 14.5 x 18.0 mm)<br>A16 (17.8 x 15.8 x 18.0 mm ) | A14 (12.4 x 14.5 x 18.0 mm) | Equivalent<br>The n!ce material is<br>being offered in the A14<br>size which is also offered<br>for IPS e.max CAD.<br>n!ce material is not<br>offered in A16 block size<br>at this point. | | | | | | | | | | | | | | | | | | | | | | Pre-milled TiBase<br>interface (screw<br>channel hole) | Sizes: Large (L)<br>Small (S) | Sizes: Large (L) | Equivalent<br>The n!ce material is<br>being offered with L<br>screw channel size which<br>is also offered for IPS<br>e.max CAD<br>n!ce material is not<br>offered with (s) screw<br>channel at this point | | | | | | | | | | | | | | | | | | | | | # Table 1 – Summary of the subject device and primary predicate device characteristic {6}------------------------------------------------ | Feature | Primary Predicate Device<br>IPS e.max CAD Abutment<br>Solutions (K132209) | Subject Devices<br>Straumann® n!ce Glass<br>Ceramic A14 Blocks. | Equivalence<br>Discussion | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Chemical<br>Composition | lithium disilicate glass Ceramic | lithium disilicate – lithium<br>aluminosilicate reinforced<br>glass ceramic | Equivalent<br>Both materials are in the<br>family of lithium<br>disilicate glasses | | Crystallization<br>State as<br>Supplied | Partially crystallized; final<br>crystallization done by dental<br>laboratory | Fully Crystalized | Equivalent<br>Both materials are fully<br>crystallized when fitted<br>in the patient's mouth | | Mandrel Design | The mandrel is designed to be<br>compatible with the material<br>holders present on mills marketed<br>by Sirona under the trade names<br>CEREC and inLab and other third-<br>party mills. | The mandrel is designed to be<br>compatible with the material<br>holders present on mills<br>marketed by Sirona under the<br>trade names CEREC and<br>inLab and other third-party<br>mills. | Equivalent<br>Both the subject and<br>predicate designs can be<br>effectively processed in<br>mills designed to mate to<br>the Sirona style mandrel. | | Minimum Wall<br>Thickness | 1.0 mm | 1.0 mm | Identical | | Maximum<br>Mesostructure<br>Angulation | 20° | 20° | Identical | | Design Workflow | Per the Sirona CEREC InLab, software version 3.6 and Cerec<br>SW (Version 4.2) | | Identical<br>Please note n!ce is NOT<br>a new material added to<br>software. We claim<br>compatibility with the<br>existing software cleared<br>for IPS e.max CAD | | Manufacturing<br>Workflow | Per the Sirona CEREC MC X and MC XL milling systems | | Identical | | Feature | Primary Predicate Device<br>IPS e.max CAD Abutment<br>Solutions (K132209) | Subject Devices | Equivalence<br>Discussion | | Compatible ti-<br>bases | NBRS 3.5<br>NBRS 4.3<br>NBRS 5.0<br>NBRS 6.0<br>NB A 4.5<br>NB A 5.0 S<br>BL 3.3 S<br>BL 4.1<br>B C 3.4<br>B C 4.1<br>B C 5.0 | RC Variobase® for CEREC<br>NC Variobase® for CEREC<br>RN Variobase® for CEREC<br>WN Variobase® for CEREC | Equivalent<br>Compatibility of<br>predicate device to<br>Straumann Variobase®<br>for CEREC is supported<br>by the reference device<br>per K151324,<br>Variobase® for CEREC®<br>(Institut Straumann AG) | | Compatible ti-<br>base platform<br>diameters | Not disclosed | NC:<br>4.5 mm<br>RC:<br>4.6 mm<br>RN:<br>5.0 mm<br>WN:<br>7.0 mm | Equivalent<br>Compatibility of predicate<br>device to<br>Straumann Variobase®<br>for CEREC is supported<br>by the reference device<br>per K151324,<br>Variobase® for<br>CEREC® (Institut<br>Straumann AG) | {7}------------------------------------------------ {8}------------------------------------------------ | Feature | Refernce Device Device<br>Variobase for CEREC<br>(K151324) | Subject Devices<br>Straumann® n!ce Glass<br>Ceramic A14 Blocks | Equivalence<br>Discussion | | | | | | | | | | | | | | | | | | | | | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications For<br>Use | The Straumann® Variobase® for<br>CEREC® are titanium alloy<br>abutments placed onto Straumann<br>dental implants to provide support<br>for customized prosthetic<br>restorations. Straumann®<br>Variobase® for CEREC®<br>abutments are indicated for screw-<br>retained single tooth or cement-<br>retained single tooth and bridge<br>restorations.<br>All digitally designed copings<br>and/or crowns for use with the<br>Straumann® Variobase® for<br>CEREC® abutments are to be<br>designed using Sirona inLab<br>software (Version 3.65) or Sirona<br>CEREC Software (Version 4.2)<br>and manufactured using a Sirona<br>CEREC or inLab MC X or MC XL<br>milling unit. | The Straumann n!ce Glass<br>Ceramic A14 Blocks are<br>intended to be ceramic<br>mesostructures cemented to<br>the Ti-base for a two-piece<br>hybrid abutment for single<br>tooth restorations or hybrid<br>abutment crowns, used in<br>conjunction with endosseous<br>dental implant to restore<br>chewing function. The<br>following compatibilities<br>apply:<br>Ti-Base manufacturer system Reference Block interface size Straumann RC Variobase® for CEREC 022.0024 L NC Variobase® for CEREC 022.0025 L RN Variobase® for CEREC 022.0019 L WN Variobase® for CEREC 022.0020 L | | | | | | | | | | | | | | | | | | | | | Equivalent<br>Straumann n!ce glass<br>ceramic was shown to be<br>substantially equivalent<br>to IPS e.max CAD per<br>K170354 cleared on<br>June 7, 2017. | | Ti-base Material | Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb) | | Identical<br>Same Ti-base is used for<br>subject device | | | | | | | | | | | | | | | | | | | | | | Ti-base Diameter<br>(base) | NC: 4.5 mm<br>RC: 4.6 mm<br>RN: 5.0 mm<br>WN: 7.0 mm | | Identical<br>Same Ti-base is used for<br>subject device | | | | | | | | | | | | | | | | | | | | | | Ti-base post<br>height | 4.7 mm | | Identical<br>Same Ti-base is used for<br>subject device | | | | | | | | | | | | | | | | | | | | | | Ti-base gingiva<br>height | NC: 0.65 mm<br>RC: 0.85 mm<br>RN and WN: N/A - defined by the neck of the tissue level implant | | Identical<br>Same Ti-base is used for<br>subject device | | | | | | | | | | | | | | | | | | | | | # Table 2 – Substantial Equivalence Comparison with reference device Variobase for CEREC (K151324) {9}------------------------------------------------ | Feature | Refernce Device<br>Variobase for CEREC<br>(K151324) | Subject Devices<br>Straumann® n!ce Glass<br>Ceramic A14 Blocks | Equivalence<br>Discussion | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Coping/ Crown<br>Material | Compatible with any milling<br>blanks cleared for use with the<br>CEREC MC X and MC XL<br>milling systems (i.e., containing<br>the pre-machined mounting<br>hole). Currently available:<br>inCoris ZI meso (K123664)<br>Ivoclar IPS e.max<br>CAD(K132209)<br>Ivoclar Telio CAD (K093708) | Straumann n!ce Glass Ceramic | Equivalent<br>Straumann n!ce glass<br>ceramic was shown to be<br>substantially equivalent<br>to IPS e.max CAD per<br>K170354 cleared on<br>June 7, 2017.<br>The compatibility of the<br>n!ce glass blocks with<br>the existing IPS e.max<br>CAD milling program is<br>validated as part of this<br>submission | | Angulation | 20° | 20° | Identical | | Compatible<br>CAD software | Sirona inLab software (Version 3.65) or Sirona CEREC Software<br>(Version 4.2) | | Identical | | Compatible<br>milling unit | Sirona CEREC or inLab MC X or MC XL milling unit. | | Identical | {10}------------------------------------------------ | Performance Data: | Test data to support the evaluation of the subject n!ce® | | |-------------------|----------------------------------------------------------|--| | | Glass- Ceramic A14 Blocks has been submitted or | | | | referenced as follows: | | - Product performance testing per ISO 6872, Dentistry-Ceramic materials, ISO 14801, Dentistry-Implants-Dynamic fatigue test for endosseous dental implants, FDA guidance Root-form endosseous dental implants and endosseous dental implant abutments and ISO 7991, Glass—Determination of coefficient of mean linear thermal expansion. - Transport and package testing per ISTA 2A and ● the standards referenced therein. - Effects of steam sterilization on product performance consistent with FDA guidance Reprocessing Medical Devices in Health Care Setting: Validation Methodsand Labeling, Guidance for Industry and Food and Drug Administration Staff, Appendix C. - Steam sterilization validation per ISO 17665 series ● standards - Biocompatibility assessment per the ISO 10993 series of standards. - Chemical characterization per ISO 10993-18, Biological . evaluation of medical devices—Part 18: Chemical characterization of materials. - Evaluation of shelf life per ASTM F1980, Standard Guide . for Accelerated Aging of Sterile Barrier Systems for Medical Devices. - . Laboratory processing including Workflow validation, and Machinability of blocks ### Conclusions: Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K171773](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K171773) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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