(111 days)
This device is a ceramic blank for fabrication of dental restoration in anterior and posterior locations. This device is used for fabricating copings, crowns, inlays, veneers and bridges.
The device is a strong and esthetic dental ceramic blank that is used by dental laboratories for fabrication of dental prosthetics such as copings, crowns and bridges. The device is comprised mainly of zirconium oxide powder and is used by dental CAD/CAM systems currently available in the market. The device is initially manufactured in a partially sintered state and is milled to specifications using standard CAD/CAM milling machines by dental technicians. The milled units are then sintered fully to the final state that is capable of being used in dental restoration procedures by dentists.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them.
The document is a 510(k) premarket notification letter from the FDA to A&D Dental Innovations, LLC regarding their PRISM Zirconia device. It primarily focuses on:
- FDA's substantial equivalence determination: Stating that the device is substantially equivalent to a legally marketed predicate device (Prismatik™ Clinical Zirconia, K060104).
- Regulatory information: Such as trade name, regulation number, classification, and general controls.
- Indications for Use: What the device is intended for.
- Device Description: General information about the device's material and manufacturing process.
- Substantial Equivalence justification: Briefly mentioning that performance testing (flexural strength, thermal expansion, solubility) was performed to establish substantial equivalence.
However, the document does not elaborate on:
- Specific acceptance criteria values for the performance tests.
- The actual reported device performance values against those criteria.
- Details about the study design: Such as sample size for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types.
- Information about training sets (sample size, ground truth establishment).
To answer your question thoroughly, I would need a more detailed study report or technical document that outlines the specific testing conducted, the quantitative results obtained, and the predefined acceptance criteria.
§ 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.