(475 days)
Not Found
No
The summary describes a dental porcelain system utilizing CAD/CAM technology for fabrication, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a dental porcelain system used for fabricating dental restorations (crowns, bridges, inlays, etc.). While these restorations improve function and aesthetics, the device itself is a material for fabrication, not a device that directly administers therapy or treats a disease.
No
Explanation: The device is described as a dental porcelain system for fabricating restorations like crowns and bridges, not for diagnosing medical conditions. The performance studies mentioned relate to material properties (flexural strength, solubility), not diagnostic accuracy.
No
The device description explicitly states it is a "dental porcelain system composed of zirconia based blocks," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of dental restorations (crowns, bridges, inlays, onlays). This is a manufacturing process for a medical device that will be placed in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as a dental porcelain system composed of zirconia-based blocks used with CAD/CAM technology. This aligns with a material used in dental fabrication, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a material used in the creation of a dental prosthesis, which is a medical device, but the material itself is not an IVD.
N/A
Intended Use / Indications for Use
For the fabrication of metal free single and multiple unit crowns/bridges, inlays, onlays bonded dental restorations.
Product codes
EIH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
§ 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.
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