(18 days)
TEMPFX ESTHETIC PROVISIONAL SYSTEM is indicated for fabrication of provisional dental restorations.
The TEMPFX ESTHETIC PROVISIONAL SYSTEM includes visible light cured resin based composites and accessories used to create provisional restorations for patients awaiting final prosthodontic restoration.
The provided text is a 510(k) summary for the DENTSPLY TEMPFX ESTHETIC PROVISIONAL SYSTEM. This document focuses on the regulatory submission for a dental material and does not contain information about acceptance criteria, device performance from a study, or any details related to AI/algorithm performance.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or multi-reader multi-case studies, as they are not present in the provided text.
The document primarily covers:
- Contact information and submission date.
- Trade name, classification name, and predicate device.
- Device description and intended use.
- Claim of substantial equivalence to predicate devices based on component use and biocompatibility testing.
- FDA's letter of clearance and confirmation of substantial equivalence.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.