Cleared Abbreviated

K092501 - LIGHT-ACTIVATED LOW-STRESS THIOL-ENE CO...

K092501 is an FDA 510(k) clearance for LIGHT-ACTIVATED LOW-STRESS THIOL-ENE CO..., manufactured by Novocol, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K092501 · Novocol, Inc. · Dental device
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Nov 2009
Decision
90d
Days
Class 2
Risk

K092501 is an FDA 510(k) clearance for the LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL. 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 12, 2009 after a review of 90 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.

View all Novocol, Inc. devices

FDA 510(k) Submission Details - K092501

510(k) Number K092501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2009
Decision Date November 12, 2009
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 690
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K092501.
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