Cleared Traditional

K933080 - ORTHOTECH DURA-GOLD BARCKETS (FDA 510(k) Clearance)

Class I Dental device.

K933080 · Orthotech · Dental device
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Mar 1994
Decision
273d
Days
Class 1
Risk

K933080 is an FDA 510(k) clearance for the ORTHOTECH DURA-GOLD BARCKETS. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Orthotech (Tampa, US). The FDA issued a Cleared decision on March 23, 1994 after a review of 273 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Orthotech devices

Submission Details

510(k) Number K933080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1993
Decision Date March 23, 1994
Days to Decision 273 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 127d · This submission: 273d
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.