Cleared Traditional

K141994 - BULK FILL FLOWABLE COMPOSITE (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141994 · Novocol, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Nov 2014
Decision
115d
Days
Class 2
Risk

K141994 is an FDA 510(k) clearance for the BULK FILL FLOWABLE COMPOSITE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Novocol, Inc. (Louisville, US). The FDA issued a Cleared decision on November 14, 2014 after a review of 115 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Novocol, Inc. devices

Submission Details

510(k) Number K141994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2014
Decision Date November 14, 2014
Days to Decision 115 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 127d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 928
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K141994.
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