ORIGIN ZIRCONIA

K110719 · B&D Dental Technologies · EIH · Aug 11, 2011 · Dental

Device Facts

• Record ID: K110719
• Device Name: ORIGIN ZIRCONIA
• Applicant: B&D Dental Technologies
• Product Code: EIH · Dental
• Decision Date: Aug 11, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Origin Zirconia Dental Material is an integrated system of dental ceramic which supports dental restorations and which are milled into prosthetic devices such as Crowns, Bridges, and Copings for partial and fully edentulous patients. The material can be milled into a variety of customized dental restorations to meet the specific needs of individual dental patient is named by a physician or dentists written prescription specifying the type of restoration to be produced. Origin Zirconia is intended to be used as a biocompatible material to be milled into precise customized dental restoration units for either crowns, copings or bridges which may be further processed by the addition of ceramic layering to create aesthetic lifelike restorations. Origin Zirconia is intended to be used as prescribed by a qualified and licensed physician or dentist by a written prescription which names the patient for which each individual dental restoration to be produced.

Device Story

Origin Zirconia is a dental ceramic material used to fabricate prosthetic restorations; specifically crowns, bridges, and copings. The material is supplied as a block or disc intended for milling into customized dental units. The device is used in a dental laboratory or clinical setting by dental professionals. The milled zirconia units serve as a structural framework that may be further processed with ceramic layering to achieve aesthetic, lifelike results. The final restoration is placed in the patient's mouth to restore function and appearance. The device benefits patients by providing a biocompatible, durable, and customized solution for tooth replacement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Zirconia-based dental ceramic material. Form factor: blocks or discs for milling into customized dental restorations (crowns, bridges, copings). Biocompatible material. No software or electronic components.

Indications for Use

Indicated for partial and fully edentulous patients requiring dental restorations, including crowns, bridges, and copings. Use requires a written prescription from a qualified, licensed physician or dentist.

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

Mr. Joon Hwang B&D Dental Technologies 2371 South Presidents Drive, Suite E West Valley City, Utah 84119

AUG 1 1 2011

Re: K110719 Trade/Device Name: Origin Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: March 15, 2011 Received: June 2, 2011

Dear Mr. Hwang:

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. Hwang

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 1 1 5809.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/ResourcesforYou/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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## ications for Use

510(K) Number: Device Name: Origin Zirconia Indications for Use:

The Origin Zirconia Dental Material is an integrated system of dental ceramic which supports dental restorations and which are milled into prosthetic devices such as Crowns, Bridges, and Copings for partial and fully edentulous patients. The material can be milled into a variety of customized dental restorations to meet the specific needs of individual dental patient is named by a physician or dentists written prescription specifying the type of restoration to be produced.

Origin Zirconia is intended to be used as a biocompatible material to be milled into precise customized dental restoration units for either crowns, copings or bridges which may be further processed by the addition of ceramic layering to create aesthetic lifelike restorations.

Origin Zirconia is intended to be used as prescribed by a qualified and licensed physician or dentist by a written prescription which names the patient for which each individual dental restoration is to be produced.

Prescription Use Yes Over-The-Counter Use _No_ AND/OR (Part 21 CFR 801 Subpart D) (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)

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