(89 days)
CERANA is designed to be used in class I primary and secondary caries/replacement of filling, class II primary and secondary caries and replacement of filling; restoration of ceramic crowns and repair of ceramic inlays; and class IV restorations.
CERANA is an all-ceramic inlay that has the same translucency as enamel, can be finished and polished just like enamel and has the same natural color as enamel. The inlays are pre-etched, silanised and ready to use, when removed from the hygienic blister package.
The provided document is a 510(k) summary for a dental device (CERANA) and not a study report. Therefore, it does not contain the acceptance criteria or a study proving the device meets those criteria in the format requested.
510(k) summaries primarily establish substantial equivalence to a predicate device, focusing on technological characteristics and intended use, rather than presenting detailed performance study results with specific acceptance criteria.
The sections you requested (acceptance criteria table, sample sizes, expert qualifications, etc.) are typically found in clinical study reports or summaries of performance testing, which are not present in this 510(k) submission.
Explanation of document content regarding performance:
- Technological Characteristics: The document states that CERANA "has been tested to show comparison with the IPS Empress predicate device material." This implies some form of testing was done to demonstrate similarity/equivalence, but no specific performance metrics, acceptance criteria, or study details are provided.
- Substantial Equivalence: The FDA's letter (on pages 2-3) confirms the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the applicant, which includes demonstrating similar technological characteristics and intended use.
- No detailed study information: The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details of ground truth establishment.
- Information on expert panels, adjudication methods, or MRMC studies.
- Standalone algorithm performance or training set details, as this is a physical dental material, not an AI/software device.
§ 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.