ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI

K102538 · Jyoti Ceramic Industries Private Limited · EIH · Oct 27, 2010 · Dental

Device Facts

• Record ID: K102538
• Device Name: ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI
• Applicant: Jyoti Ceramic Industries Private Limited
• Product Code: EIH · Dental
• Decision Date: Oct 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

ZIECON® Zirconia Ceramic Blanks are designed for 4 manufacturing ceramic dental restorations such as single crowns or bridgeworks. The ceramic dental blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques & MOM for design and processing to the patient-specific anterior/posterior tooth/bridge specification provided by the dental practitioner.

Device Story

ZIECON® Zirconia Ceramic Dental Blanks are pre-formed ceramic blocks used by dental laboratories to manufacture custom dental restorations. The device serves as raw material for CAD/CAM milling systems. Dental practitioners provide patient-specific specifications for anterior or posterior crowns or bridges; laboratory technicians use CAD/CAM software and milling equipment to machine the blank into the final restoration. The zirconia material provides the structural foundation for the prosthetic. The device is intended for professional use in a laboratory setting to create patient-specific dental prosthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Zirconia ceramic. Form factor: Dental blanks for CAD/CAM milling. Processing: Machined via customer-operated milling centers. Intended for fabrication of crowns and bridges.

Indications for Use

Indicated for the fabrication of ceramic dental restorations, including single crowns and bridgeworks, for patients requiring anterior or posterior tooth replacement.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Mr. Raju Merani Technical Director Jyoti Ceramic Industries PVT, LTD C-21, NICE, Satpur, Nashik-422 007 Maharashtra INDIA

OCT 2 7 2010

Re: K102538

Trade/Device Name: ZIECON® Zirconia Ceramic Dental Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: July 15, 2010 Received: September 3, 2010

Dear Mr. Merani:

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.

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Page 2- Mr. Merani

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 (OS) 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/ucm115809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

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## Indication for Use

12102538

OCT 27 2010

510(K) Number (if Known) :

Device Name

: ZIECON® Zirconia Ceramic Dental Blanks.

Indication for Use

ZIECON® Zirconia Ceramic Blanks are designed for 4 manufacturing ceramic dental restorations such as single crowns or bridgeworks. The ceramic dental blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques & MOM for design and processing to the patient-specific anterior/posterior tooth/bridge specification provided by the dental practitioner.

Prescription Use: X (Part 21 CFR 801 Subpart D)

AND/OR Over the Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

:

uation (ODE)

Susan Runne

(Division Sign-ni) Division of Anesthesiology, General Hospital infection Control, Dental Devices

.3(k) Number: k-toa53f