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K Number
K041098
Device Name
COOL TEMP NATURAL
Manufacturer
COLTENE AG
Date Cleared
2004-05-13

(16 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

Coltène Cool Temp Natural, in Vita® shades A1, A2 and A3.5, is indicated for temporary crown- and bridge restorations used for all techniques, i.e. with matrices or templates as well as Direct application in the dental laboratory.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental material (Cool Temp Natural), not a study report for an AI/ML medical device.

Therefore, I cannot extract any information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details as requested. The document does not contain any of these elements.

§ 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.