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K Number
K101540
Device Name
GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
Manufacturer
NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
Date Cleared
2010-10-29

(148 days)

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

Granitec® Dual-Cure Core Build-Up is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure and core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.

N'Durance Dimer Core is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure an d core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.

Device Description

Not Found

AI/ML Overview

This document is largely a 510(k) clearance letter from the FDA for two dental devices, Granitec® Dual-Cure Core Build-Up and N'Durance Dimer Core. It states that the devices are substantially equivalent to legally marketed predicate devices.

The letter itself does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory approval document based on a finding of substantial equivalence, not a detailed report of performance testing.

Therefore, I cannot provide the requested information from the provided text. The document outlines the FDA's decision based on a review of the manufacturer's submission, but the details of the performance study and acceptance criteria are not included in this letter.

§ 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.