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K Number
K142371
Device Name
Luminesse PMMA
Manufacturer
TALLADIUM, INC.
Date Cleared
2015-04-24

(242 days)

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

The Luminesse PMMA is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges.

Device Description

The Luminesse PMMA is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. The document is a 510(k) premarket notification letter from the FDA regarding a dental device called "Luminesse PMMA" and its indications for use. It primarily discusses regulatory compliance and contact information. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

§ 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.