Cleared Traditional

K133836 - OPTIGLAZE COLOR

K133836 is the FDA 510(k) clearance for OPTIGLAZE COLOR by GC America, Inc.. It is a Class 2 Dental device (product code EBD) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K133836 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
78d
Days
Class 2
Risk

K133836 is an FDA 510(k) clearance for the OPTIGLAZE COLOR. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on March 6, 2014 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all GC America, Inc. devices

Submission Details

510(k) Number K133836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2013
Decision Date March 06, 2014
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 127d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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 - EBD Coating, Filling Material, Resin

All 26
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