SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL

• K Number: K110484
• Device Name: SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
• Manufacturer: NOVOCOL, INC.
• Date Cleared: 2011-05-17 ( 88 days)
• Product Code: EBG
• Regulation Number: 872.3770
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

"Self Cure Temporary Crown and Bridge Material" is indicated for the fabrication of temporary crown, partial crown, inlay, onlay and/or bridges.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Self Cure Temporary Crown and Bridge Material." This type of document does not typically contain the detailed information required to describe acceptance criteria and the specifics of a study proving a device meets those criteria, especially for software-based or AI/ML devices.

The 510(k) letter primarily states that the device is substantially equivalent to a predicate device and is intended for the fabrication of temporary crowns, partial crowns, inlays, onlays, and/or bridges.

Therefore,Based on the provided document, I cannot extract the information required to populate the table and answer the questions regarding acceptance criteria and the study details. This document is a regulatory approval letter, not a study report.

Regulation Number and Section

§ 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.