(149 days)
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.
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This document is a 510(k) premarket notification acceptance letter from the FDA for a dental material named "Origin Zirconia." It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics that would be typically associated with AI/ML devices.
The information provided is primarily related to the regulatory clearance of a dental material, not a software algorithm or an AI device. Therefore, most of the requested fields regarding acceptance criteria, study details, and AI-specific metrics (like MRMC studies, standalone performance, training sets, ground truth establishment) are not applicable to the content of this document.
However, I can extract the general "indications for use" as this represents the intended purpose and, implicitly, the minimum functional requirements for the dental material.
Here's the breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: The document describes the "Indications for Use" for the Origin Zirconia Dental Material. These act as the functional acceptance criteria for the material itself. It states it should support dental restorations and be milled into prosthetic devices (Crowns, Bridges, Copings). It also needs to be biocompatible and customizable for individual patients under prescription. The 510(k) clearance implies that the device meets the safety and effectiveness standards comparable to a predicate device for these uses.
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Reported Device Performance: The document does not provide specific quantitative performance metrics (e.g., strength, durability, fit accuracy) in a table. It only states that the device is "substantially equivalent" to legally marketed predicate devices. The FDA's clearance is based on the material meeting these functional indications for use and demonstrating substantial equivalence, which would imply performance similar to existing devices on the market for these applications.
- Table (Conceptual, based on indications):
| Acceptance Criteria (Indications for Use) | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Integrated system of dental ceramic which supports dental restorations. | Deemed substantially equivalent to predicate devices for supporting dental restorations. |
| Milled into prosthetic devices such as Crowns, Bridges, and Copings for partial and fully edentulous patients. | Deemed substantially equivalent to predicate devices for milling into Crowns, Bridges, and Copings. |
| Customizable dental restorations to meet specific patient needs. | Deemed substantially equivalent to predicate devices for customization to individual patient needs. |
| Biocompatible material. | Deemed substantially equivalent to predicate devices, implying appropriate biocompatibility for dental use. |
| Able to be further processed by the addition of ceramic layering to create aesthetic lifelike restorations. | Deemed substantially equivalent to predicate devices, implying suitability for ceramic layering. |
| Intended for use as prescribed by a qualified and licensed physician or dentist by a written prescription naming the patient for which each individual dental restoration is to be produced (Prescription Use Yes). | Cleared for Prescription Use, meaning its use case and safety profile require professional oversight and patient-specific prescriptions. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Present: This document does not mention any test set sample sizes or data provenance as it pertains to a material rather than an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Information Not Present: This concept is not applicable to the clearance of a dental material. The "ground truth" for a material would typically be its physical and chemical properties and performance characteristics, assessed through standardized lab tests and potentially clinical trials, rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Not Present: This is not applicable to the clearance of a dental material.
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
- Information Not Present: This is not applicable as the device is a dental material, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Not Present: This is not applicable as the device is a dental material, not an AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Information Not Present: The document implies that the ground truth for approving "Origin Zirconia" would relate to its physical properties, biocompatibility, and functional performance (e.g., strength, wear resistance, fit), typically assessed through laboratory testing and comparison to established predicate devices and standards for dental materials. This is not explicitly detailed in the letter.
8. The sample size for the training set
- Information Not Present: This is not applicable as the device is a dental material, not an AI system.
9. How the ground truth for the training set was established
- Information Not Present: This is not applicable as the device is a dental material, not an AI system.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The bird is positioned to the right of the text, which is arranged in a circular pattern around the bird. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
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 (800) 638-2041 or (301) 796-7100 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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§ 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.