Cleared Traditional

K873649 - FLEX GOLD (FDA 510(k) Clearance)

Class I Dental device.

K873649 · Flexmedics · Dental device
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Oct 1987
Decision
26d
Days
Class 1
Risk

K873649 is an FDA 510(k) clearance for the FLEX GOLD. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Flexmedics (Minneapolis, US). The FDA issued a Cleared decision on October 5, 1987 after a review of 26 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 Flexmedics devices

Submission Details

510(k) Number K873649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1987
Decision Date October 05, 1987
Days to Decision 26 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 127d · This submission: 26d
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.