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Granitec Dual-Cure Core Build-Up, N'Durance Dimer Core

by Novocol Inc. Dba Septodont and Confi-Dental Produc

510(k) K101540

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK101540 Date29 Oct 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Granitec Dual-Cure Core Build-Up and N'Durance Dimer Core are dental resin materials used for direct core build-up of damaged teeth to restore tooth structure prior to placement of prosthetic crowns, onlays, or inlays. They are applied by dentists in a clinical setting.

The device is supplied with a product code of EBF and is classified as a class 2 device with an abbreviated clearance type. It is regulated under 21 CFR 872.3690 as a Tooth Shade Resin Material and has been found to be substantially equivalent. The device has an FDA 510K clearance with the number K101540.

Other devices from Novocol Inc. Dba Septodont and Confi-Dental Produc

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Granitec Dual-Cure Core Build-Up used for?

    The Granitec Dual-Cure Core Build-Up is used for direct core build-up of damaged teeth to restore tooth structure prior to placement of prosthetic crowns, onlays, or inlays.

  • Is the Granitec Dual-Cure Core Build-Up supplied sterile?

    The device data does not specify if the Granitec Dual-Cure Core Build-Up is supplied sterile, it is recommended to follow the manufacturer's instructions for use.

  • What regulatory classification does the Granitec Dual-Cure Core Build-Up have?

    The Granitec Dual-Cure Core Build-Up is classified as a class 2 device with an abbreviated clearance type, regulated under 21 CFR 872.3690 as a Tooth Shade Resin Material.