Cleared Traditional

K933080 - ORTHOTECH DURA-GOLD BARCKETS

K933080 is an FDA 510(k) clearance for ORTHOTECH DURA-GOLD BARCKETS, manufactured by Orthotech. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 273-day FDA review.

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.

FDA 510(k) Submission Details - K933080

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 128d · This submission: 273d
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 K933080.
MICROARCH GOLD BRACKET
K932825 · Gac Intl., Inc. · May 1994
ALASTIK
K933501 · Unitek Corp. · Apr 1994
MEMORY WIRE
K923372 · Althan, Inc. · Apr 1994
FASCINATION CERAMIC BRACKET
K935139 · Dentauraum, Inc. · Feb 1994
REGENCY BRACKET
K936244 · Mid-American Dental Specialties, Inc. · Feb 1994
REFLECTIONS
K934881 · Cdb Corp. · Feb 1994
K933080 · ORTHOTECH DURA-GOLD BARCKETS
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