TEMPORARY CROWN AND BRIDGE MATERIAL

• K Number: K020157
• Device Name: TEMPORARY CROWN AND BRIDGE MATERIAL
• Manufacturer: J. MORITA USA, INC.
• Date Cleared: 2002-03-04 ( 46 days)
• Product Code: EBG
• Regulation Number: 872.3770
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Temporary crown and bridge material

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a "Temporary Crown and Bridge Material." This type of document is a regulatory approval for a medical device and does not contain information about acceptance criteria, study designs, sample sizes, or ground truth establishment for an AI/ML powered device.

Therefore, I cannot provide the requested information based on the given input. The document is for a traditional medical device, not an AI/ML one, and thus does not include the details of an AI/ML performance study.

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.