ZIRPRIME by NORITAKE CO., INC. | FDA 510(k) Summary

I am sorry, but the provided text from the FDA 510(k) summary does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets those criteria.

The document is primarily a letter from the FDA to Noritake Company, Incorporated, confirming the substantial equivalence of their device, Zirprime, a porcelain powder for clinical use (Product Code: EIH, Regulation Number: 21 CFR 872.6660). It outlines regulatory compliance requirements but does not include:

A table of acceptance criteria and reported device performance.
Details about a specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
Information on MRMC comparative effectiveness studies or standalone algorithm performance.
Information about training sets.

To obtain this kind of information, you would typically need to consult a more detailed submission document, such as the full 510(k) submission, if it were publicly available and contained performance data. The provided document is a notification of clearance, not a technical report on performance.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002

Noritake Company, Incorporated C/O Mr. Ivan J. Wasserman Partner Manatt, Phelps & Phillips, LLP 700 12th Street NW Suite 1100 Washington DC 20005

AUG 1 2 2011

Re: K111383

Trade/Device Name: Zirprime Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical use Regulatory Class: II Product Code: EIH Dated: May 16, 2011 Received: May 17, 2011

Dear Mr. Wasserman:

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.

{1}------------------------------------------------

Page 2- Mr. Wasserman

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely vours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known):	K111383
Device Name:	Zirprime
Indications For Use:

Zirprime is intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations.

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 (ODE)

Signature

(Division Sign-Off)
Division of Anesthesiology, General HospitalInfection Control, Dental Devices	Page 1 of
510(k) Number:	12111383

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulation Number and Section

§ 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.