Cleared Traditional

K023814 - GRADIA DIRECT

K023814 is the FDA 510(k) clearance for GRADIA DIRECT by GC America, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K023814 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all GC America, Inc. devices

Submission Details

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
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 516
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K023814.
REBILDA DC
K030914 · Voco GmbH · May 2003
GRANDIO
K030915 · Voco GmbH · May 2003
4 SEASONS
K024094 · Ivoclar Vivadent, Inc. · Feb 2003
CLEARFIL AP-X PLT
K023002 · Kuraray Medical, Inc. · Oct 2002
CLEARFIL AP-X PLT INTRO KIT
K022999 · Kuraray Medical, Inc. · Oct 2002
TWINKY STAR
K022797 · Voco GmbH · Oct 2002