(227 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 provided text is a 510(k) summary for a dental device (Straumann n!ce Glass-Ceramic Blocks). It describes the device's characteristics and compares them to a predicate device to establish substantial equivalence. However, it does not contain information about an AI/ML-driven medical device, nor does it include a study proving device performance against acceptance criteria in the context of human-in-the-loop or standalone AI performance.
The document details performance testing for the physical properties of the ceramic blocks (e.g., flexural strength, chemical solubility, thermal expansion, biocompatibility) as required for dental materials, not for an AI algorithm's diagnostic or assistive capabilities.
Therefore, I cannot extract the requested information regarding acceptance criteria, study design for AI performance, sample sizes for AI test/training sets, expert qualifications or adjudication methods for AI ground truth, or MRMC studies from the provided text.
The text focuses on materials science and engineering performance of the dental blocks themselves, not on an artificial intelligence's performance.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 graphic of three human profiles facing right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2016
Institut Straumann Ag % Jennifer Jackson Head Of Quality And Regulatory Affairs Straumann Usa, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K160262
Trade/Device Name: N!ce Lt Glass Ceramic Blocks, N!ce Ht Glass Ceramic Blocks, Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: August 17, 2016 Received: August 18, 2016
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. Isting 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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.
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 yours,
Susan Runno DDS, MA
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) K160262
Device Name
Straumann n!ce Glass-Ceramic Blocks
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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5. 510(k) Summary
| Submission ID: | K160262 |
|---|---|
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052 |
| Contact Person: | Jennifer Jackson, MSDirector of Regulatory Affairs and QualityStraumann USA, LLC+1 (978) 747-2509 |
| Prepared By: | Christopher KlaczykHead of North American Regulatory AffairsInstitut Straumann AG+41 61 965 1260 |
| Date Prepared: | July 1, 2016 |
| Product Code(s): | EIH (21 CFR 872.6660) |
| Device Class: | II (21 CFR 872.6660) |
| Classification Panel: | Dental |
| Classification Name: | Porcelain powder for clinical use (21 CFR 872.6660) |
| Proprietary Name: | Straumann® n!ce™ Glass-Ceramic Blocks |
| Predicate Device: | K051705, IPS e.max CAD (Ivoclar Vivadent, Inc.) |
| Reference Device(s): | None |
| Device Description: | Straumann® n!ce™ glass ceramic is a proprietary lithiumdisilicate (Li2O-SiO2) glass ceramic material intended to bemilled to produce prosthetic restorations for natural andendosseous dental implant abutment borne teeth. The materialis suitable for use in inlays, onlays, veneers, copings andmonolithic crown restorations. |
| Intended Use: | The n!ce™ glass ceramic is intended to be used to manufactureceramic prostheses for the restoration of natural teeth or on topof abutments. |
| Indications For Use: | Once finalized into a suitable design, the n!ce™ Glass-CeramicBlocks are indicated for use as inlays, onlays, veneers, partialcrowns and crowns. |
| Materials: | Lithium Disilicate reinforced Lithium Aluminosilicate Glass-Ceramic |
| TechnologicalCharacteristics: | A comparison of the relevant technological characteristicsbetween the subject and primary predicate devices is providedin the table that follows. |
| Performance Data: | Test data to support the evaluation of the subject n!ce™ Glass-Ceramic Blocks has been submitted as follows:• Product performance testing per ISO 6872, Dentistry-Ceramic materials and• Product performance testing per ISO 7991, Glass—Determination of coefficient of mean linear thermalexpansion.• Biocompatibility assessment per the ISO 10993 seriesstandards:o Evaluation per ISO 10993-1, Biological evaluation ofmedical devices — Part 1: Evaluation and testing withina risk management process.o Cytotoxicity assessment per ISO 10993-5, Biologicalevaluation of medical devices — Part 5: Tests for invitro cytotoxicity.o 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. |
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| Feature | Primary Predicate DeviceIvoclar Vivadent IPS e.max CAD(K051705) | Subject DevicesStraumann n!ce Glass Ceramic Blocks(K160262) | ComparisonDiscussion |
|---|---|---|---|
| Indications For Use | IPS e.max CAD is a CAD/CAMmachinable glass ceramic based on lithiumdisilicate for the preparation of fullceramic crowns, inlays, onlays, and fullceramic 3-unit anterior bridges. | Once finalized into a suitable design, then!ceTM Glass-Ceramic Blocks are indicatedfor use as inlays, onlays, veneers, partialcrowns and crowns. | EquivalentThe scope of indications for the subjectmaterial is within the scope of theindications for the predicate material. Thesubject device is not indicated for use inthe fabrication of bridges. |
| Classification Reg. | 21 CFR 872.6660 | 21 CFR 872.6660 | Identical |
| FDA Product Code | EIH | EIH | Identical |
| ChemicalComposition | Lithium disilicate glass | Lithium disilicate – lithium aluminosilicateglass | EquivalentBoth the subject and predicate materialsare based upon lithium disilicatechemistry. |
| CrystallizationState as Supplied | Partially crystallized;final crystallization done by dentallaboratory | Fully crystallized | EquivalentIn both cases the final restoration is fullycrystallized. |
| Flexural Strength | Meets ISO 6872 requirements for a TypeII, Class 3 dental ceramic material:Monolithic ceramic for single-unit anterioror posterior prostheses and for three-unitprostheses not involving molar restorationadhesively or non-adhesively cemented. | Meets ISO 6872 requirements for a TypeII, Class 2 dental ceramic material:Monolithic ceramic for single-unit anterioror posterior prostheses adhesivelycemented. | EquivalentThe indications for the subject material arewithin the scope of indications for thepredicate material. |
| Chemical Solubility | Meets ISO 6872 requirements | Meets ISO 6872 requirements | Identical |
| Radioactivity | Type II, Class 3 | Type II, Class 2 | EquivalentThe indications for the subject material arewithin the scope of indications for thepredicate material. |
| Type / Class perISO 6872 | |||
| Feature | Primary Predicate DeviceIvoclar Vivadent IPS e.max CAD(K051705) | Subject DevicesStraumann n!ce Glass Ceramic Blocks(K160262) | ComparisonDiscussion |
| Coefficient ofThermal Expansion(CTE) 100-500°C | 10.5 x 106/K | HT: 7.1 x 106/KLT: 7.2 x 106/K | EquivalentCTE is a function of the chemicalcomposition of the material and isparticular importance for the compatibilityof the stains and glazes to be used inconjunction with the material. |
| Glass TransitionTemperature (Tg) | Not Reported | HT: 497°CLT: 491°C | Unknown |
| EstheticCharacteristics | Translucency:High Translucency (HT)Low Translucency (LT)Medium Opacity (MO)Shades:HT/LT: 16 A-D and 4 BleachMO: 5 MO 0 – MO 4Color Uniformity: HomogenousFluorescence: Present | Translucency:High Translucency (HT)Low Translucency (LT)Shades:HT/LT: 6 A-DColor Uniformity: HomogenousFluorescence: Present | EquivalentThe range of translucencies and shades ofthe subject device are within the rangeoffered for the predicate device. |
| Block Dimensions | C14 block (12.4 x 14.5 x 18.0 mm) | C14 block (12.4 x 14.5 x 18.0 mm) | Identical |
| Mandrel Design | The mandrel is compatible with materialholders of Sirona CEREC and inLab mills. | The mandrel is compatible with materialholders of Sirona CEREC and inLab millsand other third-party mills. | Identical |
| Minimum WallThickness | 1.0 mm | 1.0 mm | Identical |
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litional 510(k) Submission – Straumann® n!ce™ Glass-Ceramic Block
Page 5-4
§ 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.