Cleared Traditional

K070190 - GRADIA DIRECT X

K070190 is the FDA 510(k) clearance for GRADIA DIRECT X by GC America, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K070190 · GC America, Inc. · Dental device
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Mar 2007
Decision
49d
Days
Class 2
Risk

K070190 is an FDA 510(k) clearance for the GRADIA DIRECT X. 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 March 12, 2007 after a review of 49 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 K070190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2007
Decision Date March 12, 2007
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
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
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