(79 days)
LEXATITE QUICK ACRYLIC is intended for use as a self-curing, cold-curing, resin for LEAATTE QUORTAON crowns, bridges, inlays and onlays.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental resin called "Lexatite Quick Acrylic." This letter approves the device for market based on substantial equivalence to a legally marketed predicate device.
It does NOT contain information about specific acceptance criteria or a study that proves the device meets those criteria, as typically found in a clinical trial report or a detailed 510(k) summary.
The letter focuses on the regulatory determination of substantial equivalence, which is a comparison to a predicate device, not on meeting specific performance metrics through a new study.
Therefore, I cannot provide the requested information. The document explicitly states:
- "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
- "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act..."
To answer your questions, I would need a different type of document, such as a 510(k) summary that details the performance data or a clinical study report.
§ 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.