Cleared Traditional

K902390 - AURA CERAMIC DENTAL APPLIANCE

K902390 is an FDA 510(k) clearance for AURA CERAMIC DENTAL APPLIANCE, manufactured by Progressive Technology, Inc.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K902390 · Progressive Technology, Inc. · Dental device
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Aug 1990
Decision
75d
Days
Class 1
Risk

K902390 is an FDA 510(k) clearance for the AURA CERAMIC DENTAL APPLIANCE. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Progressive Technology, Inc. (Auburn, US). The FDA issued a Cleared decision on August 13, 1990 after a review of 75 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.

FDA 510(k) Submission Details - K902390

510(k) Number K902390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1990
Decision Date August 13, 1990
Days to Decision 75 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 128d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

EJF Device Classification - Class 1, General Controls

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.

Regulatory Peers - EJF Bracket, Metal, Orthodontic

All 102
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K902390.
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K902390 · AURA CERAMIC DENTAL APPLIANCE
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