(67 days)
Bredent Breformance is intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
breformance ColdCuringPolymer is a C+B material for temporary restorations
This document is a 510(k) summary for the Bredent Breformance temporary crown and bridge resin. It does not contain any information regarding acceptance criteria, device performance tables, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies.
The document states that:
- The Bredent product is similar to a predicate device (K013869 - Ivoclar Vivadent, Inc.) in terms of technical characteristics, design, indications for use, target population, where it is used, performance, biocompatibility, and sizes/configurations.
- The presented data (which is not included in the provided text) shows that the products are "absolutely safe and effective for their intended use."
- All models have been on the market in Europe for many years "with no device failures."
- The materials used are "well researched and do not raise any kind of question regarding safety and effectiveness of the finished product."
Therefore, based solely on the provided text, I cannot describe the acceptance criteria or the study that proves the device meets them because that information is not present. The submission relies on substantial equivalence to a predicate device and anecdotal evidence of market history in Europe.
§ 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.