Cleared Traditional

K903214 - OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS (FDA 510(k) Clearance)

Class I Dental device.

K903214 · Medical Fittings, Inc. · Dental device
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Sep 1990
Decision
44d
Days
Class 1
Risk

K903214 is an FDA 510(k) clearance for the OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Medical Fittings, Inc. (Northampton, US). The FDA issued a Cleared decision on September 5, 1990 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - 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 Medical Fittings, Inc. devices

Submission Details

510(k) Number K903214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1990
Decision Date September 05, 1990
Days to Decision 44 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 127d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJF Bracket, Metal, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
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.