Cleared Traditional

GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX (K863009) - FDA 510(k) Clearance

Class I Dental device.

K863009 · Sds Dental, Inc. · Dental device
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Sep 1986
Decision
48d
Days
Class 1
Risk

K863009 is an FDA 510(k) clearance for the GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX. Classified as Articulators (product code EJP), Class I - General Controls.

Submitted by Sds Dental, Inc. (Washington, US). The FDA issued a Cleared decision on September 25, 1986 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3150 - 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 Sds Dental, Inc. devices

Submission Details

510(k) Number K863009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1986
Decision Date September 25, 1986
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 127d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJP Articulators
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3150
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.