(13 days)
No
The summary describes a dental ceramic material and its physical properties and testing, with no mention of AI or ML.
No
The device is a material (glass-ceramic blocks) used to produce dental restorations (inlays, onlays, etc.), which are prosthetic devices, not therapeutic.
No
Explanation: The device is described as a material (glass-ceramic blocks) used to create prosthetic dental restorations like inlays, onlays, and crowns. This is a therapeutic or restorative function, not a diagnostic one.
No
The device is a physical glass-ceramic block intended for milling into dental restorations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create dental restorations (inlays, onlays, veneers, partial crowns, and crowns) for natural and implant-supported teeth. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a material (glass ceramic block) that is milled to create these restorations. It's a physical component used in a dental procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on material properties (strength, thermal expansion), biocompatibility, packaging, shelf life, and machinability – all relevant to a dental restorative material, not an IVD.
- Anatomical Site: The anatomical site is teeth, which are the target of the restoration, not the source of a diagnostic sample.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a material used to physically restore damaged or missing tooth structure.
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 Planmill milling equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
natural and endosseous dental implant abutment borne teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
No animal or human clinical studies were conducted.
Description of the test set, sample size, data source, and annotation protocol
No animal or human clinical studies were conducted.
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.
- Simulated Use Validation including a machinability assessment
- Mandrel-block adhesion
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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November 14, 2017
Institut Straumann AG % Jennifer Jackson Director. Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K173410
Trade/Device Name: n!ce for Planmill Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: October 30, 2017 Received: November 1, 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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)
or tap here to enter text
Device Name
n!ce® for Planmill
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)
区 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 K173410
| 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 M. Jackson, MS
Director of Regulatory Affairs and Quality
+1 (978) 747-2509 |
| Prepared By &
Secondary Contact: | Shokoufeh Khodabandeh
Regulatory Affairs and Compliance Manager
Institut Straumann AG
+41 61 965 1260 |
| Date Prepared:
Product Code(s): | November 10, 2017
EIH |
| Device Class: | II |
| Classification
Panel: | Dental |
| Classification
Name: | Porcelain powder for clinical use (21 CFR 872.6660) |
| Common Name: | Porcelain powder for clinical use (21 CFR 872.6660) |
| Proprietary Name:
Predicate
Device(s): | n!ce® for Planmill
K160262 n!ce Glass Ceramic Blocks; Manufacturer Straumann |
| Reference
Device(s): | K170420; n!ce for Armann Girrbach;Institut Straumann AG |
| 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
Planmill milling equipment. |
| Intended Use | The n!ce® glass ceramic is intended to be used to
manufacture ceramic restorations 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 aluminosilicate ceramic reinforced with lithium
disilicate glass-ceramic material (exact same material as
previously cleared under K160262) |
| Technological
Characteristics: | A comparison of the relevant technological characteristics
between the subject and the primary predicate is provided in
the table that follows. |
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| Feature | Subject Device
n!ce Blocks for
Planmill | Primary Predicate
Devices
Straumann n!ce Glass
Ceramic Blocks
(K160262) | Equivalence
discussions |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication 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. | | Identical |
| Block
Chemical
Composition | lithium aluminosilicate
ceramic reinforced with
lithium disilicate glass-
ceramic material | lithium disilicate –
lithium aluminosilicate
glass-ceramic material | Identical
Same material
with a name
change |
| Crystallization
State as
Supplied | Fully crystallized | | Identical |
| Esthetic
Characteristics | Translucency:
Shades:
Color Uniformity:
Fluorescence: | High Translucency (HT)
Low Translucency (LT)
HT/LT: 6 A-C
Homogenous
Present | Identical |
| Block
Dimensions | C14 (12.4 x 14.5 x 18.0 mm) | | Identical |
| Feature | Subject Device
n!ce Blocks for
Planmill | Primary Predicate
Devices
Straumann n!ce Glass
Ceramic Blocks
(K160262) | Equivalence
discussions |
| Mandrel
Design | The mandrel is
compatible with
material holders of
Planmill mills. | The mandrel is
compatible with material
holders of Sirona CEREC
and inLab mills and
other third-party mills. | Equivalent
Both the subject
and predicate
designs can be
effectively
processed in the
mills
corresponding
with the mandrel
design. |
| Mandrel
Material | AlSi1Sn1MgBi Alloy | | Identical |
| Minimum Wall
Thickness of
Milled
Restoration | | 1.0 mm | Identical |
| Flexural
Strength | | Meets ISO 6872 requirements for a Type II, Class
2 dental ceramic material. | Identical |
| Radioactivity | | Meets ISO 6872 requirements for a Type II, Class
2 dental ceramic material | Identical |
| Chemical
Solubility | | Meets ISO 6872 requirements for a Type II, Class
2 dental ceramic material. | Identical |
| Coefficient of
Thermal
Expansion
(CTE) 100-
500°C | | HT: 7.1 x 10-6/K
LT: 7.2 x 10-6/K | Identical |
| Glass
Transition
Temperature
(Tg) | | HT: 497°C
LT: 491°C | Identical |
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:
6
- . 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 o medical devices - Part 1: Evaluation and testing within a risk management process.
- Cytotoxicity assessment per ISO 10993-5, Biological o evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
- Chemical characterization per ISO 10993-18, o 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.
- Simulated Use Validation including a machinability . assessment
- . Mandrel-block adhesion
No animal or human clinical studies were conducted.
- 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.