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K Number
K980799
Device Name
HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
Manufacturer
COSMEDENT, INC.
Date Cleared
1998-10-28

(240 days)

Product Code
EBG
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Used for temporary restorations.

Device Description

High Viscosity Composite Temporary (Provisional) Material

AI/ML Overview

This document is a letter from the FDA to Cosmedent, Incorporated regarding their 510(k) premarket notification for a "High Viscosity Composite Temporary Material." It primarily discusses the regulatory approval of the device based on its substantial equivalence to previously marketed devices.

Therefore, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The letter is a regulatory approval document and does not detail the technical performance or testing of the device. Consequently, I cannot populate the requested table or answer any of the questions about the study design, sample sizes, expert qualifications, or ground truth.

§ 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.