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K Number
K151088
Device Name
DMRC Bulk Fill
Manufacturer
DANVILLE MATERIALS, LLC
Date Cleared
2015-08-28

(127 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

DMRC Bulk Fill is a dual-cure (auto-cure) with light-cure acceleration) polymer-based dental restoratives that when applied to dental surfaces pretreated with suitable primers or adhesives are use as the first incrual with posterior composites, for core build-ups; and for luting posts, crowns, veneers sead any application there light transmission may be inadequate

Device Description

DMRC Bulk Fill is a dual-cure (auto-cure) with light-cure acceleration) polymer-based dental restoratives

AI/ML Overview

This document is a 510(k) premarket notification letter for a dental restorative material called "DMRC Bulk Fill." It focuses on the regulatory approval process and does not contain the kind of detailed clinical study information (acceptance criteria, device performance tables, sample sizes, expert qualifications, etc.) that you've requested regarding device performance and its proof.

Therefore, I cannot extract the requested information from the provided text.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.