Cleared Traditional

MODEL GDCH-2000 (K092851) - FDA 510(k) Clearance

Class I Dental device.

K092851 · Global Dental Direct, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
13d
Days
Class 1
Risk

K092851 is an FDA 510(k) clearance for the MODEL GDCH-2000. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Global Dental Direct, Inc. (Abbotsford, Bc, CA). The FDA issued a Cleared decision on September 29, 2009 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Global Dental Direct, Inc. devices

Submission Details

510(k) Number K092851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2009
Decision Date September 29, 2009
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 127d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

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