Cleared Abbreviated

K101540 - GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE

K101540 is an FDA 510(k) clearance for GRANITEC DUAL-CURE CORE BUILD-UP, manufactured by Novocol Inc. Dba Septodont and Confi-Dental Produc. The device is a Class 2 Dental device with product code EBF cleared through the Abbreviated 510(k) pathway after a 148-day FDA review.

K101540 · Novocol Inc. Dba Septodont and Confi-Dental Produc · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
148d
Days
Class 2
Risk

K101540 is an FDA 510(k) clearance for the GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Novocol Inc. Dba Septodont and Confi-Dental Produc (Louisville, US). The FDA issued a Cleared decision on October 29, 2010 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K101540

510(k) Number K101540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2010
Decision Date October 29, 2010
Days to Decision 148 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 128d · This submission: 148d
Pathway characteristics
Standards-based clearance path.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 878
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K101540.
SA FLOWABLE ADHESIVE
K102603 · Dmg USA, Inc. · Nov 2010
GRANDIO SO HEAVY FLOW
K102354 · Voco GmbH · Nov 2010
GRANDIO SO
K102351 · Voco GmbH · Nov 2010
BLO2X OXYGEN BLOCKER
K102526 · Pascal Co., Inc. · Oct 2010
IONOLUX PRO
K102450 · Voco GmbH · Oct 2010
BEAUTIFIL FLOW PLUS
K101603 · Shofu Dental Corp. · Aug 2010
K101540 · GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
Download PDF Novocol Inc. Dba Sept…