(17 days)
Once finalized into a suitable design, the n!ce™ glass-ceramic blocks are indicated for use as inlays, onlays, veneers, partial crowns and crowns.
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 Amann Girrbach milling equipment.
This document is a 510(k) premarket notification for a dental ceramic material, "N!ce Glass Ceramic Blocks For Amann Girrbach." The information provided does not pertain to a medical device powered by Artificial Intelligence (AI). Therefore, the questions regarding acceptance criteria and study designs that are relevant to AI-powered devices (such as sample size, expert ground truth, MRMC studies, standalone performance, and training sets) are not applicable.
The document describes a physical medical device (dental blocks) and its laboratory performance testing against established ISO standards for ceramic materials. It focuses on demonstrating substantial equivalence to a predicate device, which is a common regulatory pathway for non-AI medical devices.
Here's how the provided information relates to the general concept of "acceptance criteria" for this specific device:
1. Table of Acceptance Criteria and Reported Device Performance (as relevant for a non-AI device):
| Acceptance Criteria (Met by ISO Standard Reference) | Description | Reported Device Performance |
|---|---|---|
| Flexural Strength | Meets requirements for a Type II, Class 2 dental ceramic material (ISO 6872). | "Meets ISO 6872 requirements for a Type II, Class 2 dental ceramic material." |
| Radioactivity | Meets requirements for a Type II, Class 2 dental ceramic material (ISO 6872). | "Meets ISO 6872 requirements for a Type II, Class 2 dental ceramic material." |
| Chemical Solubility | Meets requirements for a Type II, Class 2 dental ceramic material (ISO 6872). | "Meets ISO 6872 requirements for a Type II, Class 2 dental ceramic material." |
| Coefficient of Thermal Expansion (CTE) | Tested per ISO 7991, Glass—Determination of coefficient of mean linear thermal expansion. | HT: 7.1 x 10^-6/K, LT: 7.2 x 10^-6/K (Specific values provided, implied to be within acceptable range for dental use, though no explicit acceptance range is given in the document). |
| Glass Transition Temperature (Tg) | Not explicitly linked to an ISO standard for acceptance, but a characteristic provided. | HT: 497°C, LT: 491°C (Specific values provided). |
| Biocompatibility | Evaluation per ISO 10993-1, Cytotoxicity per ISO 10993-5, Chemical characterization per ISO 10993-18. | Assessed "per ISO 10993-1," "per ISO 10993-5," and "per ISO 10993-18" (implies meeting these standards). |
| Transport and Package Testing | Per ISTA 2A and referenced standards. | Assessed "per ISTA 2A and the standards referenced therein." |
| Shelf Life | Per ASTM F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. | Assessed "per ASTM F1980." |
Study Proving Device Meets Acceptance Criteria (as relevant for a non-AI device):
The "study" proving the device meets acceptance criteria refers to performance testing conducted according to recognized international standards.
2. Sample size used for the test set and the data provenance:
- The document refers to "test data" and "product performance testing" according to ISO standards. For materials testing, the "sample size" would typically refer to the number of physical blocks or specimens tested for each characteristic (e.g., flexural strength, chemical solubility). The specific numerical sample sizes for each test are not detailed in this summary.
- Data Provenance: Not explicitly stated, but typical for medical device manufacturers, this testing would be conducted within their own labs or by accredited third-party labs, adhering to Good Laboratory Practice (GLP) or similar quality systems. The data is retrospective in the sense that the testing was completed before the 510(k) submission. No country of origin for the data is specified, but the manufacturer is based in Switzerland (Institut Straumann AG) and the US (Straumann USA, LLC).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This question is not applicable as the device is a physical material, not an AI algorithm that diagnoses or interprets data. "Ground truth" in this context refers to the measured physical properties of the material, which are determined by standardized laboratory methods and equipment, not by human expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human readers or interpretations, especially for establishing ground truth in AI/ML validation studies. For material properties, the "truth" is determined by direct measurement following a validated test methodology.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This question is not applicable. MRMC studies are specific to evaluating the clinical performance of diagnostic or AI-assisted devices where human interpretation is involved. This device is a material used for restorations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. A "standalone" performance evaluation refers to an AI algorithm's performance without human interaction. This device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by objective, quantitative measurements of its physical and chemical properties (e.g., flexural strength in MPa, chemical solubility in µg/cm², CTE in K⁻¹) as outlined by the referenced ISO and ASTM standards. Biocompatibility is assessed based on standardized biological evaluation methods.
8. The sample size for the training set:
- This question is not applicable. Training sets are used in machine learning for developing AI algorithms. This device is a manufactured material, not an AI.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 8.
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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
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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
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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)
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- 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.
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510(k) Summary
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| Indications For Use: | 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 Devicen!ce Blocks for Amann Girrbach | Primary Predicate DevicesStraumann n!ce Glass Ceramic Blocks(K160262) |
|---|---|---|
| Block ChemicalComposition | lithium disilicate – lithium aluminosilicate glass | |
| CrystallizationState as Supplied | Fully crystallized | |
| EstheticCharacteristics | Translucency: | High Translucency (HT)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 materialholders of Amann Girrbach mills. | The mandrel is compatible with materialholders of Sirona CERECand inLab mills and other third-party mills. |
| Mandrel Material | AlMgSiSn Alloy with Alodine 1500 anti-corrosive coating | AlSi1Sn1MgBi Alloy |
| Minimum WallThickness | 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 ofThermal Expansion(CTE) 100-500°C | HT: | $7.1 x 10^6/K$ |
| LT: | $7.2 x 10^6/K$ | |
| Glass TransitionTemperature (Tg) | HT: | 497°C |
| LT: | 491°C |
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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:Product performance testing per ISO 6872, Dentistry—Ceramic materials ISO 7991, Glass—Determination of coefficient of meanlinear thermal expansion. Biocompatibility assessment as follows: Evaluation per ISO 10993-1, Biological evaluation ofmedical devices — Part 1: Evaluation and testing withina risk management process. Cytotoxicity assessment per ISO 10993-5, Biologicalevaluation of medical devices — Part 5: Tests for invitro cytotoxicity. Chemical characterization per ISO 10993-18, Biologicalevaluation of medical devices—Part 18: Chemicalcharacterization of materials. Transport and package testing per ISTA 2A and thestandards referenced therein. Evaluation of shelf life per ASTM F1980, Standard Guidefor Accelerated Aging of Sterile Barrier Systems forMedical Devices. |
|---|---|
| Conclusions: | Based upon our assessment of the design and applicableperformance data, the subject devices have been determined tobe substantially equivalent to the identified predicate devices. |
§ 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.