Cleared Traditional

UNI-STICK PLASTIC LIGATURE, MODIFIED (K926578) - FDA 510(k) Clearance

Class I Dental device.

K926578 · American Orthodontics · Dental device
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Mar 1993
Decision
191d
Days
Class 1
Risk

K926578 is an FDA 510(k) clearance for the UNI-STICK PLASTIC LIGATURE, MODIFIED. Classified as Band, Elastic, Orthodontic (product code ECI), Class I - General Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 191 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.

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Submission Details

510(k) Number K926578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1992
Decision Date March 31, 1993
Days to Decision 191 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
64d slower than avg
Panel avg: 127d · This submission: 191d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECI Band, Elastic, 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.