(28 days)
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.
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.
The provided text describes a 510(k) summary for "CDC Zirconia Blanks," which are yttria-stabilized zirconia blocks for CAD/CAM milling of dental restorations. The submission seeks to demonstrate substantial equivalence to a predicate device (KO93560, Upcera Zirconia Blanks), rather than proving specific performance criteria through a detailed study.
Therefore, many of the requested elements pertaining to AI or software-based medical devices (like acceptance criteria for performance metrics, study design with human readers, ground truth establishment, training sets, etc.) are not applicable to this submission, as it is for a physical dental material and relies on the established safety and effectiveness of similar existing devices.
Here's an assessment based on the available information:
1. A table of acceptance criteria and the reported device performance
This 510(k) submission for CDC Zirconia Blanks does not define specific performance acceptance criteria in terms of diagnostic accuracy, sensitivity, specificity, or other metrics typically seen for AI/software devices. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device.
The reported "performance" is primarily a statement of safety and effectiveness based on similarity to previously cleared devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Substantial Equivalence to Predicate Device (KO93560, Upcera Zirconia Blanks) based on: | "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 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." |
| Does not raise new questions regarding safety and effectiveness. | "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." |
| Meeting the stated 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." |
2. Sample size used for the test set and the data provenance
Not applicable. This submission focuses on the material's composition and manufacturing, not a diagnostic or AI-driven performance study needing a test set of data samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical dental material, not an AI or software product for diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth in the context of a diagnostic performance study is not relevant here. The "truth" for this submission is that the material's properties and intended use are substantially equivalent to a legally marketed predicate.
8. The sample size for the training set
Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a training set for an algorithm.
{0}------------------------------------------------
510(k) Summary
OCT 2 4 200
CDC Zirconia Blanks
-
- Date of Summary Preparation:
September 18, 2012
- Date of Summary Preparation:
F: (310) 618-1238
CDC Zirconia Blanks
-
- Submitting Firm:
-
- Contact Person:
Jerry Doviack, CDT President Continental Dental Laboratory 1873 Western Way Torrance, CA 90501 USA T: (310) 618-8821
Continental Dental Laboratory
-
- Name of Medical Device Proprietary Name:
Regulation Name: Regulation Number: Product Code: Classification Name: Classification:
- Name of Medical Device Proprietary Name:
Porcelain Powder for Clinical Use 872.6660 દામ Powder, Porcelain Class II
-
- Predicate Device:
KO93560, Upcera Zirconia Blanks Shenyang Upcera Company, Ltd.
- Predicate Device:
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
Page 13 of 35
{1}------------------------------------------------
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
{2}------------------------------------------------
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.
{3}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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
{4}------------------------------------------------
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:
Page 12 of 35
§ 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.