Predicate Devices

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a glass-ceramic material for dental restorations and its performance testing, with no mention of AI or ML.

Therapeutic

No
The device is a material (glass-ceramic blocks) used to create prosthetic restorations like inlays, onlays, and crowns, not a device that itself delivers therapy or treatment.

Diagnostic

No

The device is a material for fabricating prosthetic dental restorations and does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "glass ceramic material" intended to be milled, indicating a physical material, not software. The performance studies also focus on material properties and biocompatibility, not software validation.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The device is used to create dental restorations (inlays, onlays, veneers, partial crowns, and crowns) for natural and implant-supported teeth. This is a therapeutic and restorative use, not a diagnostic one.
Device Description: The device is a material (glass ceramic block) that is milled to produce these restorations. It's a component used in the fabrication of a medical device (the dental restoration), not a device that performs a diagnostic test.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
Performance Studies: The performance studies listed focus on the material's physical properties (strength, thermal expansion), biocompatibility, and packaging/shelf life. These are relevant to a material used in a medical device, but not to an IVD.
Predicate Device: The predicate device (IPS e.max CAD) is also a material used for dental restorations, further supporting the classification as a non-IVD.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

EIH

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

natural teeth or on top of abutments

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 thermal expansion.
• Biocompatibility assessment per the ISO 10993 series standards:
o Evaluation per ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process.
o Cytotoxicity assessment per ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
o Chemical characterization per ISO 10993-18, 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K051705, IPS e.max CAD

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

None

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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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

1

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

2

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)

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 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:

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3

5. 510(k) Summary

Submission ID:	K160262
Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052
Contact Person:	Jennifer Jackson, MS
Director of Regulatory Affairs and Quality
Straumann USA, LLC
+1 (978) 747-2509
Prepared By:	Christopher Klaczyk
Head of North American Regulatory Affairs
Institut 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 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.
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.
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.
Materials:	Lithium Disilicate reinforced Lithium Aluminosilicate Glass-
Ceramic
Technological
Characteristics:	A comparison of the relevant technological characteristics
between the subject and primary predicate devices is provided
in 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 thermal
expansion.
• Biocompatibility assessment per the ISO 10993 series
standards:
o Evaluation per ISO 10993-1, Biological evaluation of
medical devices — Part 1: Evaluation and testing within
a risk management process.
o Cytotoxicity assessment per ISO 10993-5, Biological
evaluation of medical devices — Part 5: Tests for in
vitro cytotoxicity.
o Chemical characterization per ISO 10993-18, 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.
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.

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

Shades:
HT/LT: 16 A-D and 4 Bleach
MO: 5 MO 0 – MO 4

Color Uniformity: Homogenous
Fluorescence: Present | Translucency:
High Translucency (HT)
Low Translucency (LT)

Shades:
HT/LT: 6 A-D

6

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

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