Cleared Traditional

K023814 - GRADIA DIRECT

K023814 is an FDA 510(k) clearance for GRADIA DIRECT, 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 76-day FDA review.

K023814 · GC America, Inc. · Dental device
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Jan 2003
Decision
76d
Days
Class 2
Risk

K023814 is an FDA 510(k) clearance for the GRADIA DIRECT. 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 January 30, 2003 after a review of 76 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K023814

510(k) Number K023814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2002
Decision Date January 30, 2003
Days to Decision 76 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
52d faster than avg
Panel avg: 128d · This submission: 76d
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 931
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K023814.
GRANDIO
K030915 · Voco GmbH · May 2003
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K030133 · Dentalez Group · Apr 2003
4 SEASONS
K024094 · Ivoclar Vivadent, Inc. · Feb 2003
SCULPTURE PLUS NANO-HYBRID COMPOSITE
K023742 · Pentron Laboratory Technologies · Jan 2003
MICROHYBRID 11
K022971 · Ab Ardent · Nov 2002
MICROFILL 13
K022972 · Ab Ardent · Nov 2002
K023814 · GRADIA DIRECT
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