Cleared Traditional

K052462 - G-COAT

K052462 is the FDA 510(k) clearance for G-COAT by GC America, Inc.. It is a Class 2 Dental device (product code EBD) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K052462 · GC America, Inc. · Dental device
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Oct 2005
Decision
42d
Days
Class 2
Risk

K052462 is an FDA 510(k) clearance for the G-COAT. 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 October 20, 2005 after a review of 42 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 K052462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2005
Decision Date October 20, 2005
Days to Decision 42 days
Submission Type Traditional
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
85d faster than avg
Panel avg: 127d · This submission: 42d
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 32
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K052462.
EASY GLAZE
K082285 · Voco GmbH · Oct 2008
DURAFINISH ALL-CURE, MODEL S296
K080549 · Parkell, Inc. · May 2008
PAINT- ON POLISH AGENT
K070306 · Dentsply International, Inc. · Mar 2007
BISCOVER LED
K051999 · Bisco, Inc. · Aug 2005
BISCOVER LV
K043168 · Bisco, Inc. · Feb 2005
PARKELL RESIN GLAZE
K040599 · Parkell, Inc. · Apr 2004