(112 days)
TESCERA Opaquer/Sculpting Resin is a pre-wetting agent for placing and sculpting layers of composites.
When mixed with TESCERA Opaquer Powder, TESCERA Opaquer/Sculpting Resin is a dual-cured material (light/heat) used to opaque/mask metal substrates and other materials used in dental restorations.
TESCERA Opaquer/Sculpting Resin is a dual-cured (light/heat), low viscosity resin for used for wetting composite instruments. With TESCERA Opaquer Powder, TESCERA Opaquer/Sculpting Resin is a dual-cured (light/heat) tooth colored opaquing/masking composite system specially formulated to opaque/mask the substrates used in dental restorations.
This document describes a 510(k) premarket notification for a dental device, comparing it to predicate devices. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through empirical testing with a defined sample size, ground truth, or expert evaluation.
The provided text focuses on establishing substantial equivalence based on intended use, chemical composition, and mechanical/physical properties compared to existing legally marketed devices, rather than a clinical or performance study with defined acceptance criteria.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets those criteria because the provided text does not contain this type of data.
Specifically, the document states: "Side by side comparisons of TESCERA Opaquer/Sculpting Resin and Opaquer Powder to the predicate devices D/C OPAQUER and MODELING RESIN clearly demonstrate that the applicant device is substantially equivalent to the legally marked devices. TESCERA Opaquer/Sculpting Resin and Opaquer Powder were tested for biocompatibility and they were found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of TESCERA Opaquer/Sculpting Resin and Opaquer Powder." This indicates a comparison for substantial equivalence and biocompatibility testing, not a performance study with acceptance criteria.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.