(17 days)
None
No
The summary describes a glass-ceramic material for dental restorations and its physical and biological properties. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
No
The device is a material for dental restorations (inlays, onlays, veneers, partial crowns, crowns), which replaces lost tooth structure rather than treating a disease or condition.
No
This device is a material (glass-ceramic blocks) used to produce prosthetic dental restorations. It is not used to diagnose a condition, but rather to treat or restore a damaged tooth/area.
No
The device description clearly states it is a glass-ceramic material intended to be milled, indicating it is a physical material, not software.
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 intended for use as dental restorations (inlays, onlays, veneers, partial crowns, and crowns). These are physical devices placed in or on the body.
- Device Description: The device is a glass-ceramic material intended to be milled into dental prosthetics. This describes a material used for fabrication, not a test performed on a sample from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility. The performance studies focus on material properties (strength, thermal expansion, biocompatibility) and packaging, not diagnostic accuracy.
IVDs are typically tests or systems used to analyze samples like blood, urine, tissue, etc., to provide information about a person's health status. This device is a restorative material.
N/A
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
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. The mandrel bonded to the blocks is compatible with Amann Girrbach milling equipment.
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 (dental)
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 or included by reference as follows:
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 medical devices — Part 1: Evaluation and testing within a risk management process.
Cytotoxicity assessment per ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
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.
K160262. Straumann® n!ce™ Glass Ceramic Blocks
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
Not Found
§ 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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is often associated with medicine and healthcare. The caduceus is composed of three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
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
1
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
2
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.
ട.
510(k) Summary
4
| 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 Device
n!ce Blocks for Amann Girrbach | Primary Predicate Devices
Straumann n!ce Glass Ceramic Blocks
(K160262) |
|--------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Block Chemical
Composition | lithium disilicate – lithium aluminosilicate glass | |
| Crystallization
State as Supplied | Fully crystallized | |
| Esthetic
Characteristics | 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 material
holders of Amann Girrbach mills. | The mandrel is compatible with material
holders of Sirona CEREC
and inLab mills and other third-party mills. |
| Mandrel Material | AlMgSiSn Alloy with Alodine 1500 anti-
corrosive coating | AlSi1Sn1MgBi Alloy |
| Minimum Wall
Thickness | 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 of
Thermal Expansion
(CTE) 100-500°C | HT: | $7.1 x 10^6/K$ |
| | LT: | $7.2 x 10^6/K$ |
| Glass Transition
Temperature (Tg) | HT: | 497°C |
| | LT: | 491°C |
5
| 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 mean
linear thermal expansion. Biocompatibility assessment as follows: Evaluation per ISO 10993-1, Biological evaluation of
medical devices — Part 1: Evaluation and testing within
a risk management process. Cytotoxicity assessment per ISO 10993-5, Biological
evaluation of medical devices — Part 5: Tests for in
vitro cytotoxicity. 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. |