(14 days)
Designed for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include both anterior and posterior locations.
CERCON® CERAM S PORCELAIN is a dental ceramic veneering material developed for veneering Cercon zirconia or an equivalent zirconium oxide substructure for fixed prosthodontics devices that include both anterior and posterior crowns/bridges. The CERCON® CERAM S PORCELAIN System consists of Dentin/Transparent/Incisal, Liner/Opaque, Shoulder, and Correction/Glaze/Stain Porcelains. The final restoration matches more shades than the predicate device.
This document is a 510(k) summary for a dental ceramic veneering material named CERCON® CERAM S PORCELAIN. It does not contain information about a study with acceptance criteria, sample sizes, expert ground truth, or adjudication methods in the context of device performance metrics typically associated with AI/ML devices or diagnostic tools.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Cercon® Ceram K011333) based on:
- Device Description: It describes the use of the new porcelain for veneering zirconia substructures in fixed prosthodontic devices.
- Intended Use: It specifies the use on zirconia for single tooth or bridge type restorations in anterior and posterior locations.
- Technological Characteristics: It highlights that CERCON® CERAM S PORCELAIN is a modification of the predicate device with minor formulation changes.
- Biocompatibility: It states that the device was evaluated and passed biocompatibility testing for cytotoxicity.
- Components: It mentions that all components have been used in legally marketed devices.
The conclusion is that the prior use of components, similarity in formulation, and biocompatibility data support the safety and effectiveness of the new device.
Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The document is a regulatory submission for a material, not a diagnostic or AI-powered device that would typically involve such performance studies.
§ 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.