(91 days)
Metal free single posterior crowns, multiple unit anterior crowns/bridges, inlays, onlays bonded dental restorations.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device named "Zirkonzahn Ice," which is classified as "Porcelain Powder for Clinical Use." This document primarily deals with the administrative notification and clearance process rather than detailed study results or acceptance criteria.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from this document. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, not necessarily a demonstration of meeting specific performance criteria through a new study.
The document does not contain the following information:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number or qualifications of experts used to establish ground truth.
- Adjudication method for a test set.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Results from a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
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Image /page/0/Picture/1 description: The image shows a stylized drawing of three parallel lines that are curved and slightly jagged. The lines are thick and black, and they appear to be flowing or rippling. The overall impression is abstract and somewhat minimalist.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 2006
Zirkonzahn GmbH C/O Ms. Donna Marie Hartnett Official Correspondent 67 Main Street Silver Creek, New York 14136
Re: K061851
Trade/Device Name: Zirkonzahn Ice Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 26, 2006 Received: July 5, 2006
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.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Ms. Harmett
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lien, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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): | K061851 |
|---|---|
| Device Name: | Zirkonzahn Ice |
| Indications for Use: | Metal free single posterior crowns, multiple unit anterior crowns/bridges, inlays, onlays bonded dental restorations. |
| Prescription Use | X (Part 21 CFR 801 Subpart D) |
| AND/OR | 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)
Robert S. Betz DDS for Dr. Susan Renner
siology. General Hospital, r com ( Control, Dental Devices
Number: K061851
§ 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.