Straumann® n!ce™ glass ceramic is a proprietary lithium 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 Planmill milling equipment.

AI/ML Overview

This document is a 510(k) summary for a dental glass-ceramic material, n!ce for Planmill, which means it describes the device's equivalence to existing legally marketed devices, rather than a study proving its efficacy or performance against defined acceptance criteria in the conventional sense. The focus here is on demonstrating substantial equivalence to a predicate device, specifically the n!ce Glass Ceramic Blocks (K160262). Therefore, the "acceptance criteria" and "device performance" in this context refer to the criteria met to show substantial equivalence and the tests performed to support that claim.

Given the context of a 510(k) summary for a material intended for milling dental restorations, the "device" is the n!ce® glass-ceramic blocks, and its "performance" is assessed against established material standards and characteristics deemed equivalent to the predicate device.

Here's an interpretation of the information requested, tailored to the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" generally refer to the established standards or characteristics that the new device must meet or demonstrate equivalence to, compared to the predicate device. "Reported device performance" refers to the results of tests conducted on the new device to show it meets these criteria or is substantially equivalent.

Feature / Acceptance Criteria (demonstrate equivalence to predicate)	Reported Device Performance (n!ce® for Planmill)
Indications for Use (Identical to predicate)	Once finalized into a suitable design, the n!ce® glass-ceramic blocks are indicated for use as inlays, onlays, veneers, partial crowns and crowns. (Identical to predicate)
Block Chemical Composition (Identical to predicate)	lithium aluminosilicate ceramic reinforced with lithium disilicate glass-ceramic material (Same material as previously cleared under K160262, with a name change)
Crystallization State as Supplied (Identical to predicate)	Fully crystallized (Identical to predicate)
Esthetic Characteristics (Identical to predicate)	Translucency (High (HT) & Low (LT)), Shades (6 A-C), Color Uniformity (Homogenous), Fluorescence (Present) (Identical to predicate)
Block Dimensions (Identical to predicate)	C14 (12.4 x 14.5 x 18.0 mm) (Identical to predicate)
Mandrel Design (Functionally equivalent to predicate)	The mandrel is compatible with material holders of Planmill mills. (Equivalent; both subject and predicate designs can be effectively processed in corresponding mills)
Mandrel Material (Identical to predicate)	AlSi1Sn1MgBi Alloy (Identical to predicate)
Minimum Wall Thickness of Milled Restoration (Identical to predicate)	1.0 mm (Identical to predicate)
Flexural Strength (Meets ISO 6872 requirements for Type II, Class 2 dental ceramic material, identical to predicate)	Meets ISO 6872 requirements for a Type II, Class 2 dental ceramic material. (Identical to predicate)
Radioactivity (Meets ISO 6872 requirements for Type II, Class 2 dental ceramic material, identical to predicate)	Meets ISO 6872 requirements for a Type II, Class 2 dental ceramic material. (Identical to predicate)
Chemical Solubility (Meets ISO 6872 requirements for Type II, Class 2 dental ceramic material, identical to predicate)	Meets ISO 6872 requirements for a Type II, Class 2 dental ceramic material; requirements for Type II, Class 2 dental ceramic material. (Identical to predicate)
Coefficient of Thermal Expansion (CTE) 100-500°C (Identical to predicate)	HT: 7.1 x 10-6/K; LT: 7.2 x 10-6/K (Identical to predicate)
Glass Transition Temperature (Tg) (Identical to predicate)	HT: 497°C; LT: 491°C (Identical to predicate)
Biocompatibility (Meets ISO 10993 requirements)	Evaluation per ISO 10993-1, Cytotoxicity per ISO 10993-5, Chemical characterization per ISO 10993-18. (Assessment performed to demonstrate compliance with these standards)
Transport and Packaging Testing	Per ISTA 2A and referenced standards.
Shelf-Life Evaluation	Per ASTM F1980.
Simulated Use Validation	Included machinability assessment.
Mandrel-block adhesion	Testing performed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each individual material test (e.g., number of blocks tested for flexural strength, or specific number of samples for biocompatibility). It references ISO and ASTM standards, which typically specify minimum sample sizes for their respective tests.

Test Set Description: The "test set" consists of the n!ce® for Planmill glass-ceramic blocks.
Sample Sizes: Not explicitly stated in terms of exact numbers, but testing was conducted according to international standards (e.g., ISO 6872, ISO 7991, ISO 10993 series, ASTM F1980). These standards would dictate the minimum sample sizes required for statistically valid results.
Data Provenance: The studies were conducted by Institut Straumann AG. The country of origin of the data is not specifically mentioned, but given the company's location (Switzerland), it is likely European. The studies are prospective in the sense that they were conducted specifically for this submission to evaluate the new device against established benchmarks and the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This type of information is not applicable to this 510(k) submission. This device is a material, not an AI or diagnostic device that requires expert human interpretation of results to establish "ground truth" for a test set. The "ground truth" here is defined by objective material properties measured according to established scientific and engineering standards (e.g., chemical composition, mechanical strength, biocompatibility), not by expert consensus or interpretations of images as would be the case for a diagnostic AI.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or subjective clinical endpoints, often in the context of diagnostic performance or clinical trials. As this is a material science and engineering evaluation, such methods are not used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic imaging devices or AI algorithms that assist human readers in interpreting medical cases. The device in question is a dental material, not a diagnostic tool or AI.

6. Standalone Performance Study

Yes, a form of "standalone" performance was done, in the sense that the material itself was characterized and tested against various international standards and its own specifications. The performance data listed (e.g., ISO 6872, ISO 7991, ISO 10993 series, ASTM F1980, simulated use validation, mandrel-block adhesion) represent tests performed on the n!ce® for Planmill blocks to demonstrate their inherent properties and functionality. This is akin to standalone performance for a material device, showing it meets established technical and safety benchmarks.

7. Type of Ground Truth Used

The "ground truth" for this material device is based on objective scientific and engineering measurements of its physical, chemical, and biological properties, as defined by international standards (e.g., ISO, ASTM). This includes:

Material properties: Chemical composition, crystallization state, dimensions, flexural strength, radioactivity, chemical solubility, CTE, glass transition temperature.
Biocompatibility: Demonstrated through adherence to ISO 10993 series, which involves specific laboratory tests (e.g., cytotoxicity, chemical characterization).
Functional performance: Machinability, mandrel-block adhesion, and resistance to environmental factors (transport, storage).

There is no reliance on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or treatment efficacy studies. Comparisons were made against the properties of the predicate device (n!ce Glass Ceramic Blocks K160262), which itself would have had its "ground truth" established through similar objective measurements and standards.

8. Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train machine learning algorithms. The n!ce® for Planmill is a physical material, not an AI or software device that undergoes training.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated above (no training set for a physical material device).

Summary

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November 14, 2017

Institut Straumann AG % Jennifer Jackson Director. Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K173410

Trade/Device Name: n!ce for Planmill Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: October 30, 2017 Received: November 1, 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 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 (QS) regulation (21 CFR Part 820);

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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,

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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

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Indications for Use

510(k) Number (if known)

or tap here to enter text

Device Name

n!ce® for Planmill

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)

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary K173410

Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and Quality+1 (978) 747-2509
Prepared By &Secondary Contact:	Shokoufeh KhodabandehRegulatory Affairs and Compliance ManagerInstitut Straumann AG+41 61 965 1260
Date Prepared:Product Code(s):	November 10, 2017EIH
Device Class:	II
ClassificationPanel:	Dental
ClassificationName:	Porcelain powder for clinical use (21 CFR 872.6660)
Common Name:	Porcelain powder for clinical use (21 CFR 872.6660)
Proprietary Name:PredicateDevice(s):	n!ce® for PlanmillK160262 n!ce Glass Ceramic Blocks; Manufacturer Straumann
ReferenceDevice(s):	K170420; n!ce for Armann Girrbach;Institut Straumann AG
Device Description:	Straumann® n!ce™ glass ceramic is a proprietary lithiumdisilicate (Li2O-SiO2) glass ceramic material intended tobe milled to produce prosthetic restorations for naturaland 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 withPlanmill milling equipment.
Intended Use	The n!ce® glass ceramic is intended to be used tomanufacture ceramic restorations for the restoration ofnatural teeth or on top of abutments.
Indications ForUse:	Once finalized into a suitable design, the n!ce® glass-ceramicblocks are indicated for use as inlays, onlays, veneers,partial crowns and crowns.
Materials:	lithium aluminosilicate ceramic reinforced with lithiumdisilicate glass-ceramic material (exact same material aspreviously cleared under K160262)
TechnologicalCharacteristics:	A comparison of the relevant technological characteristicsbetween the subject and the primary predicate is provided inthe table that follows.

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Feature	Subject Devicen!ce Blocks forPlanmill	Primary PredicateDevicesStraumann n!ce GlassCeramic Blocks(K160262)	Equivalencediscussions
Indication foruse	Once finalized into a suitable design, the n!ce®glass-ceramic blocks are indicated for use asinlays, onlays, veneers, partial crowns and crowns.		Identical
BlockChemicalComposition	lithium aluminosilicateceramic reinforced withlithium disilicate glass-ceramic material	lithium disilicate –lithium aluminosilicateglass-ceramic material	IdenticalSame materialwith a namechange
CrystallizationState asSupplied	Fully crystallized		Identical
EstheticCharacteristics	Translucency:Shades:Color Uniformity:Fluorescence:	High Translucency (HT)Low Translucency (LT)HT/LT: 6 A-CHomogenousPresent	Identical
BlockDimensions	C14 (12.4 x 14.5 x 18.0 mm)		Identical
Feature	Subject Devicen!ce Blocks forPlanmill	Primary PredicateDevicesStraumann n!ce GlassCeramic Blocks(K160262)	Equivalencediscussions
MandrelDesign	The mandrel iscompatible withmaterial holders ofPlanmill mills.	The mandrel iscompatible with materialholders of Sirona CERECand inLab mills andother third-party mills.	EquivalentBoth the subjectand predicatedesigns can beeffectivelyprocessed in themillscorrespondingwith the mandreldesign.
MandrelMaterial	AlSi1Sn1MgBi Alloy		Identical
Minimum WallThickness ofMilledRestoration		1.0 mm	Identical
FlexuralStrength		Meets ISO 6872 requirements for a Type II, Class2 dental ceramic material.	Identical
Radioactivity		Meets ISO 6872 requirements for a Type II, Class2 dental ceramic material	Identical
ChemicalSolubility		Meets ISO 6872 requirements for a Type II, Class2 dental ceramic material.	Identical
Coefficient ofThermalExpansion(CTE) 100-500°C		HT: 7.1 x 10-6/KLT: 7.2 x 10-6/K	Identical
GlassTransitionTemperature(Tg)		HT: 497°CLT: 491°C	Identical

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Performance Data:

Test data to support the evaluation of the subject n!ce® Glass-Ceramic Blocks has been submitted or included by reference as follows:

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. Product performance testing per ISO 6872, Dentistry-Ceramic materials
ISO 7991, Glass—Determination of coefficient of mean . linear thermal expansion.
. Biocompatibility assessment as follows:
- Evaluation per ISO 10993-1, Biological evaluation of o medical devices - Part 1: Evaluation and testing within a risk management process.
- Cytotoxicity assessment per ISO 10993-5, Biological o evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
- Chemical characterization per ISO 10993-18, o Biological evaluation of medical devices—Part 18: Chemical characterization of materials.
. Transport and package testing per ISTA 2A and the standards referenced therein.
Evaluation of shelf life per ASTM F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Simulated Use Validation including a machinability . assessment
. Mandrel-block adhesion

No animal or human clinical studies were conducted.

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.

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.