CDC ZIRCONIA BLANKS

K122972 · Continental Dental Ceramics, Inc. (Dba Continental · EIH · Oct 24, 2012 · Dental

Device Facts

• Record ID: K122972
• Device Name: CDC ZIRCONIA BLANKS
• Applicant: Continental Dental Ceramics, Inc. (Dba Continental
• Product Code: EIH · Dental
• Decision Date: Oct 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CDC Zirconia Blanks are intended for use with CAD/CAM technology to produce all-ceramic dental restorations (copings, frameworks, inlays, onlays, crowns and bridges) as prescribed by a dentist. This product is for professional use only. Not for use by the general public or OTC.

Device Story

CDC Zirconia Blanks consist of pressed and sintered Yttria-stabilized zirconia blocks. Used in dental laboratories with CAD/CAM milling machines to fabricate all-ceramic dental restorations (copings, frameworks, inlays, onlays, crowns, bridges). After milling, blocks undergo sintering to achieve high-strength ceramic properties. Operated by dental professionals; output is a custom-milled dental prosthetic. Benefits include high-strength, durable, all-ceramic restorative material for clinical dental applications.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by successful prior use of components in legally marketed devices and similarity of formulations to previously cleared devices.

Technological Characteristics

Material: Yttria-stabilized Zirconia. Form factor: Pressed and sintered blocks for CAD/CAM milling. Energy source: N/A (mechanical milling). Sterilization: Not specified. Connectivity: N/A.

Indications for Use

Indicated for professional use in the fabrication of all-ceramic dental restorations, including copings, frameworks, inlays, onlays, crowns, and bridges, via CAD/CAM technology as prescribed by a 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.

Predicate Devices

• Upcera Zirconia Blanks (K093560)

Submission Summary (Full Text)

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K122972

## 510(k) Summary

# OCT 2 4 200

### CDC Zirconia Blanks

- 1. Date of Summary Preparation:
September 18, 2012

F: [phone]

CDC Zirconia Blanks

- 2. Submitting Firm:
- 3. Contact Person:

Jerry Doviack, CDT President Continental Dental Laboratory 1873 Western Way Torrance, CA 90501 USA T: [phone]

Continental Dental Laboratory

- 4. Name of Medical Device Proprietary Name:
Regulation Name: Regulation Number: Product Code: Classification Name: Classification:

Porcelain Powder for Clinical Use 872.6660 દામ Powder, Porcelain Class II

- 5. Predicate Device:
KO93560, Upcera Zirconia Blanks Shenyang Upcera Company, Ltd.

#### 6. Description of Medical Device:

CDC Zirconia blanks are pressed and sintered blocks of Yttria stabilized Zirconia for use in CAD/CAM milling machines. After the Zirconia block is milled, it is sintered into a high strength all ceramic material suitable for copings, inlays, crowns, and bridges.

#### ર. Intended Use

CDC Zirconia Blanks are intended for use with CAD/CAM technology to produce all-ceramic dental restorations (copings, frameworks, inlays, onlays, crowns and bridges) as prescribed by a dentist.

#### Safety & Effectiveness 7.

The successful prior use of the components of CDC Zirconia Blanks product in legally marketed devices, the similarity of the formulations used in this device and earlier devices, and the

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substantially equivalence of CDC Zirconia Blanks to prior cleared devices support the safety and effectiveness of the CDC Zirconia blank product for the intended use.

It has been shown in this 510(k) submission that the difference between CDC Zirconia Blanks and the predicate device do not raise any questions regarding its safety and effectiveness.

.

END OF SECTION

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.

Public Health Service

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

Continental Dental Ceramics, Incorporated Mr. Jerry Doviack, CDT President 1873 Western Way Torrance, California 90501

24
2012

Re: K122972

Trade/Device Name: CDC Zirconia Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 18, 2012 Received: September 26, 2012

Dear Mr. Doviack:

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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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/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.

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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## Indications for Use

510(k) Number (if known): K122972

Device Name: CDC Zirconia Blanks

Range of Indications:

CDC Zirconia Blanks are intended for use with CAD/CAM technology to produce all-ceramic dental restorations (copings, frameworks, inlays, onlays, crowns and bridges) as prescribed by a dentist.

This product is for professional use only. Not for use by the general public or OTC.

Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Pease

(Division Sign-Off) (Division Sign-Off)
Division of Anestheslology, General Hospital
Division of Anestheslology, General Devices Division of Ancolnoontal Devices

510(k) Number:

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