(89 days)
The Dental Ceramic is indicated for use with the:
- preparation of inlays .
- preparation of onlays .
- preparation of veneers .
- preparation of crowns .
The Dental Ceramic is indicated for use with CEREC devices marketed by Sirona, in Bensheim, Germany. The blooks are compatible with all CEREC devices up to The Dental Ocramio is manuted i are compatible with the CEREC model MC XL and Inlab model MC XL.
The present Dental Ceramic blocks are grindable leucite reinforced glass ceramic blocks for use with CEREC® and inLab® devices marketed by Sirona, Bensheim, Germany. The blocks are are compatible with all CEREC models up to CEREC 3 and inLab but are not compatible with the CEREC model MC XL and Inlab model MC XL.
This 510(k) summary for K080479, "Dental Ceramic," does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This document is a premarket notification for a dental ceramic material, which is a Class II device. The submission is an "Abbreviated 510(k)" as described in FDA's guidance, meaning it primarily demonstrates substantial equivalence by providing chemical composition and certification of compliance with relevant consensus standards.
Therefore, I cannot provide the requested information in the format specified because the provided text does not describe any specific performance criteria, testing, or studies that would typically be associated with software or AI/ML-driven medical devices.
The key points from the provided text are:
- Device Type: Dental Ceramic blocks (material).
- Purpose: Used for inlays, onlays, veneers, and crowns with CEREC® and inLab® devices.
- Regulatory Pathway: Abbreviated 510(k), demonstrating substantial equivalence through chemical composition and compliance with consensus standards.
- No mention of AI/ML components: The device is a material, not a diagnostic or AI-powered system that would require performance studies against specific acceptance criteria.
- No mention of studies: The document states "Data provided in this submission to establish substantial equivalence includes chemical composition and certification of compliance with relevant consensus standards." This indicates a different type of evaluation than a clinical or performance study with a test set, ground truth, or expert readers.
If this were a submission for a device involving AI or software, the requested information would be crucial. However, for a dental ceramic, the regulatory requirements for demonstrating safety and effectiveness are met differently, typically through material properties testing and comparison to predicate devices, rather than clinical performance studies with specific statistical endpoints.
§ 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.