Cleared Traditional

K082171 - GRADIA CORE

K082171 is an FDA 510(k) clearance for GRADIA CORE, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K082171 · GC America, Inc. · Dental device
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Oct 2008
Decision
90d
Days
Class 2
Risk

K082171 is an FDA 510(k) clearance for the GRADIA CORE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on October 30, 2008 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 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 GC America, Inc. devices

FDA 510(k) Submission Details - K082171

510(k) Number K082171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2008
Decision Date October 30, 2008
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K082171.
FLUOROCORE 2
K083326 · Dentsply International, Inc. · Feb 2009
FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE
K083610 · 3M Company · Dec 2008
GDLS-200
K082434 · GC America, Inc. · Nov 2008
ESTELITE SIGMA QUICK
K080940 · Tokuyama Dental Corporation · Jun 2008
GRADIA FORTE
K080478 · GC America, Inc. · Jun 2008
NANOCOMPOSITE RESTORATIVE KIT
K080480 · Dmg USA, Inc. · May 2008