n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,

K160262 · Institut Straumann AG · EIH · Sep 16, 2016 · Dental

Device Facts

• Record ID: K160262
• Device Name: n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,
• Applicant: Institut Straumann AG
• Product Code: EIH · Dental
• Decision Date: Sep 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Straumann n!ce Glass-Ceramic Blocks are proprietary lithium disilicate (Li2O-SiO2) glass-ceramic blocks used for dental restorations. The blocks are milled using CAD/CAM systems to create inlays, onlays, veneers, partial crowns, and crowns for natural teeth or endosseous dental implant abutments. The device is used in dental clinics or laboratories by dental professionals. The material is supplied fully crystallized, distinguishing it from some predicates that require post-milling crystallization. The final restoration is placed by a clinician to restore tooth function and aesthetics. The device benefits patients by providing a durable, biocompatible, and esthetic restorative material for single-unit dental prostheses.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 6872 (dental ceramic materials) and ISO 7991 (coefficient of linear thermal expansion). Biocompatibility assessed per ISO 10993-1, ISO 10993-5 (cytotoxicity), and ISO 10993-18 (chemical characterization). Shelf life validated per ASTM F1980. Transport and package testing performed per ISTA 2A.

Technological Characteristics

Lithium disilicate reinforced lithium aluminosilicate glass-ceramic. Form factor: C14 blocks (12.4 x 14.5 x 18.0 mm). Compatible with Sirona CEREC and inLab mills. Fully crystallized as supplied. Meets ISO 6872 Type II, Class 2 requirements. Flexural strength and chemical solubility comply with ISO standards.

Indications for Use

Indicated for use as inlays, onlays, veneers, partial crowns and crowns in patients requiring dental prosthetic restoration.

Regulatory Classification

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.

Predicate Devices

• IPS e.max CAD (K051705)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 9005052 |
| Contact Person: | Jennifer Jackson, MS<br>Director of Regulatory Affairs and Quality<br>Straumann USA, LLC<br>[phone] |
| Prepared By: | Christopher Klaczyk<br>Head of North American Regulatory Affairs<br>Institut Straumann AG<br>[phone] |
| 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 lithium<br>disilicate (Li2O-SiO2) glass ceramic material intended to be<br>milled to produce prosthetic restorations for natural and<br>endosseous dental implant abutment borne teeth. The material<br>is suitable for use in inlays, onlays, veneers, copings and<br>monolithic crown restorations. |
| Intended Use: | The n!ce™ glass ceramic is intended to be used to manufacture<br>ceramic prostheses for the restoration of natural teeth or on top<br>of abutments. |
| Indications For Use: | Once finalized into a suitable design, the n!ce™ Glass-Ceramic<br>Blocks are indicated for use as inlays, onlays, veneers, partial<br>crowns and crowns. |
| Materials: | Lithium Disilicate reinforced Lithium Aluminosilicate Glass-<br>Ceramic |
| Technological<br>Characteristics: | A comparison of the relevant technological characteristics<br>between the subject and primary predicate devices is provided<br>in the table that follows. |
| Performance Data: | Test data to support the evaluation of the subject n!ce™ Glass-<br>Ceramic Blocks has been submitted as follows:<br>• Product performance testing per ISO 6872, Dentistry-<br>Ceramic materials and<br>• Product performance testing per ISO 7991, Glass—<br>Determination of coefficient of mean linear thermal<br>expansion.<br>• Biocompatibility assessment per the ISO 10993 series<br>standards:<br>o Evaluation per ISO 10993-1, Biological evaluation of<br>medical devices — Part 1: Evaluation and testing within<br>a risk management process.<br>o Cytotoxicity assessment per ISO 10993-5, Biological<br>evaluation of medical devices — Part 5: Tests for in<br>vitro cytotoxicity.<br>o Chemical characterization per ISO 10993-18, Biological<br>evaluation of medical devices—Part 18: Chemical<br>characterization of materials.<br>• Transport and package testing per ISTA 2A and the<br>standards referenced therein.<br>• 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. |

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| Feature | Primary Predicate Device<br>Ivoclar Vivadent IPS e.max CAD<br>(K051705) | Subject Devices<br>Straumann n!ce Glass Ceramic Blocks<br>(K160262) | Comparison<br>Discussion |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | IPS e.max CAD is a CAD/CAM<br>machinable glass ceramic based on lithium<br>disilicate for the preparation of full<br>ceramic crowns, inlays, onlays, and full<br>ceramic 3-unit anterior bridges. | Once finalized into a suitable design, the<br>n!ceTM Glass-Ceramic Blocks are indicated<br>for use as inlays, onlays, veneers, partial<br>crowns and crowns. | Equivalent<br>The scope of indications for the subject<br>material is within the scope of the<br>indications for the predicate material. The<br>subject device is not indicated for use in<br>the fabrication of bridges. |
| Classification Reg. | 21 CFR 872.6660 | 21 CFR 872.6660 | Identical |
| FDA Product Code | EIH | EIH | Identical |
| Chemical<br>Composition | Lithium disilicate glass | Lithium disilicate – lithium aluminosilicate<br>glass | Equivalent<br>Both the subject and predicate materials<br>are based upon lithium disilicate<br>chemistry. |
| Crystallization<br>State as Supplied | Partially crystallized;<br>final crystallization done by dental<br>laboratory | Fully crystallized | Equivalent<br>In both cases the final restoration is fully<br>crystallized. |
| Flexural Strength | Meets ISO 6872 requirements for a Type<br>II, Class 3 dental ceramic material:<br>Monolithic ceramic for single-unit anterior<br>or posterior prostheses and for three-unit<br>prostheses not involving molar restoration<br>adhesively or non-adhesively cemented. | Meets ISO 6872 requirements for a Type<br>II, Class 2 dental ceramic material:<br>Monolithic ceramic for single-unit anterior<br>or posterior prostheses adhesively<br>cemented. | Equivalent<br>The indications for the subject material are<br>within the scope of indications for the<br>predicate material. |
| Chemical Solubility | Meets ISO 6872 requirements | Meets ISO 6872 requirements | Identical |
| Radioactivity | Type II, Class 3 | Type II, Class 2 | Equivalent<br>The indications for the subject material are<br>within the scope of indications for the<br>predicate material. |
| Type / Class per<br>ISO 6872 | | | |
| Feature | Primary Predicate Device<br>Ivoclar Vivadent IPS e.max CAD<br>(K051705) | Subject Devices<br>Straumann n!ce Glass Ceramic Blocks<br>(K160262) | Comparison<br>Discussion |
| Coefficient of<br>Thermal Expansion<br>(CTE) 100-500°C | 10.5 x 106/K | HT: 7.1 x 106/K<br>LT: 7.2 x 106/K | Equivalent<br>CTE is a function of the chemical<br>composition of the material and is<br>particular importance for the compatibility<br>of the stains and glazes to be used in<br>conjunction with the material. |
| Glass Transition<br>Temperature (Tg) | Not Reported | HT: 497°C<br>LT: 491°C | Unknown |
| Esthetic<br>Characteristics | Translucency:<br>High Translucency (HT)<br>Low Translucency (LT)<br>Medium Opacity (MO)<br><br>Shades:<br>HT/LT: 16 A-D and 4 Bleach<br>MO: 5 MO 0 – MO 4<br><br>Color Uniformity: Homogenous<br>Fluorescence: Present | Translucency:<br>High Translucency (HT)<br>Low Translucency (LT)<br><br>Shades:<br>HT/LT: 6 A-D<br><br>Color Uniformity: Homogenous<br>Fluorescence: Present | Equivalent<br>The range of translucencies and shades of<br>the subject device are within the range<br>offered 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 material<br>holders of Sirona CEREC and inLab mills. | The mandrel is compatible with material<br>holders of Sirona CEREC and inLab mills<br>and other third-party mills. | Identical |
| Minimum Wall<br>Thickness | 1.0 mm | 1.0 mm | Identical |

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litional 510(k) Submission – Straumann® n!ce™ Glass-Ceramic Block

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