(475 days)
For the fabrication of metal free single and multiple unit crowns/bridges, inlays, onlays bonded dental restorations.
ICE Zirkon Transluzent Plus is a dental porcelain system composed of zirconia based blocks which utilizes CAD/CAM technology for dental restoration fabrication.
This document is a 510(k) submission for a dental material (ICE Zirkon Transluzent Plus), not an AI device. Therefore, the requested information regarding acceptance criteria and studies for an AI device cannot be extracted from this document. The document describes the equivalence of the new dental material to a predicate device based on material properties and established standards, not an AI algorithm's performance.
However, I can provide the information available about the dental material from the document, interpreted through the lens of device performance for that material:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Standard Reference) | Reported Device Performance (ICE Zirkon Transluzent Plus) |
|---|---|---|
| Flexural Strength | ISO 6872:2008 (Type II, Class 1a&b and 2a esthetic ceramic classification) | Not explicitly quantified in this summary, but stated to meet ISO 6872:2008 for its classification and to maintain mechanical strength. |
| Chemical Solubility | ISO 6872:2008 | Not explicitly quantified, but stated to be tested and substantially equivalent to predicate. |
| Radioactivity | ISO 6872:2008 | Not explicitly quantified, but stated to be tested and substantially equivalent to predicate. |
| Glass Transition Temperature (Tg) | Not explicitly stated (likely part of material characterization) | Not explicitly quantified, but stated to be tested and substantially equivalent to predicate. |
| Coefficient of Thermal Expansion (CTE) | Not explicitly stated (likely part of material characterization) | Not explicitly quantified, but stated to be tested and substantially equivalent to predicate. |
| Translucency | Improved over predicate device | Stated as an improvement over the predicate, while maintaining mechanical strength. |
| Biocompatibility | Substantially equivalent to predicate | Stated to be substantially equivalent to the predicate. |
2. Sample size used for the test set and the data provenance:
- This document describes testing of a physical dental material, not a software device or an AI model. Therefore, "test set" and "data provenance" as typically understood for AI models are not applicable.
- The testing performed would be on physical samples of the ceramic material. The document does not specify the number of samples used for each test (flexural strength, solubility, etc.).
- Data provenance: Not directly described, but the company is Zirkonzahn, GmbH, located in Gais, Italy. The testing would have been performed by or for the manufacturer. This is a prospective evaluation of a new material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable to a physical dental material. "Ground truth" for this device refers to objective material properties measured against established international standards (like ISO 6872:2008), not expert consensus on interpretations of images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for a physical material. Material properties are measured according to standardized protocols, not adjudicated by experts in the same way as clinical assessments or model outputs.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI device. The "device" itself is the ceramic material. Its performance is inherent in its physical and chemical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this dental material, the "ground truth" for its performance is based on measurements against established international standards and validated testing methodologies (e.g., ISO 6872:2008 for flexural strength, chemical solubility, radioactivity). It's an objective measurement of a material's properties.
8. The sample size for the training set:
- Not applicable as this is not an AI device. There is no "training set" for physical material properties.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 5,2014
Zirkonzahn, GmbH c/o Donna Marie Hartnett Attorney / Consultant Radack & Hartnett 67 Main Street Silver Creek, NY 14136
Re: K132230
Trade/Device Name: ICE Zirkon Transluzent Plus Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 29, 2014 Received: October 03, 2014
Dear Ms. Hartnett:
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
{1}------------------------------------------------
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 device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 vours.
Susan Runno, DDS, MA
Erin I. Keith, M.S. 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 (rev)
510(k) Number (if known): K132230
Device Name: ICE ZIRKON TRANSLUZENT PLUS
Indications For Use:
For the fabrication of metal free single and multiple unit crowns/bridges, inlays, onlays bonded dental restorations.
Prescription Use _X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
{3}------------------------------------------------
510(K) SUMMARY (rev 11.3.2014) Zirkon ICE Transluzent Plus
| Contact: | Manfred Gasteiger, Quality Assurance |
|---|---|
| Company: | Zirkonzahn, GmbH, An der Ahr 7, 39030 Gais, Italy |
| Telephone: | +39 0474 066 660 |
Date Prepared: January 27, 2014
| Trade Name: | ICF |
|---|---|
| Classification Name: | Por |
| Predicate Devices: | Zirl |
E Zirkon Transluzent Plus celain Powder for Clinical Use (872.6660) (Class Code EIH) konzahn ICE - K061851, Zirkonzahn, GmbH
Device Description: ICE Zirkon Transluzent Plus is a dental porcelain system composed of zirconia based blocks which utilizes CAD/CAM technology for dental restoration fabrication.
Intended Use: For the fabrication of metal free single and multiple unit crowns/bridges. inlays, onlays bonded dental restorations
Technological Characteristics: The ICE Zirkon Transluzent Plus device represents a modification of the existing Zirkonzahn ICE device (510k No. K061851) to improve the translucency of the materials while maintaining the mechanical strength. The materials are intended to used with the CAD/CAM Technology for fabrication of the restoration. Zirconia has been commonly used in dentistry in the CAD/CAM area for many years due to its high flexural strength and esthetics. ICE Zirkon Transluzent Plus is substantially equivalent to the predicate device regarding the indications for use, material properties, technical parameters, processing and biocompatibility.
Testing Summary: ICE Zirkon Transluzent Plus was tested according to ISO 6872:2008 and is classified as Type II Class 1a&b and 2a esthetic dental ceramic. The device has been tested for flexural strength, chemical solubility, radioactivity, glass transition temperature and CTE, and the results of such testing are substantially equivalent to the predicate devices. Slight differences do not adversely affect safety and effectiveness of ICE Zirkon Transluzent Plus compared to the predicate.
All of the components have been used in legally marketed devices. The formulations have not been changed in way that may adversely impact safety or efficacy.
The prior use of the components in legally marketed devices, the similarity in the formulations between the modified device and the marketed device, and the data provided regarding the modifications to the marketed device support the safety and effectiveness of the ICE Zirkon Transluzent Plus for the intended use.
Conclusion: The data submitted demonstrates that the subject device is substantially equivalent to the predicate device.
510K Summary 5-1
§ 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.