(29 days)
For use in replicating shade variations found in natural teeth For use in replicating Shade Variations using CZR Press LF porcelain.
Not Found
I'm sorry, but this document contains a letter from the FDA regarding a 510(k) premarket notification for a dental porcelain product (CZR Press LF Stains), not a study report. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth information, etc.) is not present in the provided text.
The document essentially states that the FDA has determined the device is substantially equivalent to legally marketed devices and can proceed to market, subject to various regulations. It does not contain any performance data or study results.
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Public Health Service
MAY 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Noritake Company, Incorporated C/O Mr. Ivan J. Wasserman, Counsel Collier Shannon Scott, PLLC Washington Harbour, Suite 400 3050 K Street NW Washington, District of Columbia 20007
Re: K050920
Trade/Device Name: CZR Press LF Stains Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: April 11, 2005 Received: April 12, 2005
Dear Mr. Wasserman:
We have reviewed your Section 510(k) premarket notification of intent to market the device in indication we nave reviewed your Section 510(x) premated is substantially equivalent (for the indications for referenced above and have decemblied the devices marketed in interstate commerce tise stated in the encrosure/ to regally manations p Medical Device Amendments, or to devices that prov to May 26, 1970, the chaomism and 67 in ovisions of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with the provised application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application Ast., The opper Act (Act) that do hot require approval or a provisions of the Act. The general therefore, market the device, subject to annual registration, listing of devices, good Controls provisions of the nechade prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in the if your device is classified (Sec above) into Existing major regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the Oods on the concerning your device in the Federal Register.
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Page 2 - Mr. Ivan J. Wasserman, Esq.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease be advised that 1 271 b issuaired to our device complies with other requirements of the Act or that I Dr. I has muse a dotenulations administered by other Federal agencies. You must comply with all 1 coloral statutes and 10 god and limited to: registration and listing (21 CFR Part 807); an the Ace s requirements) instruments as set forth in the requirements as set forth in the quality iabeling (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) I ms lotter with a a your finding of substantial equivalence of your device to a legally prematice notification. "The starsification 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 ir you active of Compliance at (240) 276-0115. Also, please note the regulation entitled, Comace in Orited of Gempharket notification' (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general 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,
Clare
Chiu S. Lin. PhD 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): K050920
Device Name: CZR Press LF Stains
Indications For Use:
For use in replicating shade variations found in natural teeth For use in replicating Shade Variations using CZR Press LF porcelain.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Susan Quay
Sivision Sign-Off) Civision of Anesthesiology, General Hospital, Intection Control, Dental Devices
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10(k) Number .
§ 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.