Cleared Traditional

UNI-STICK PLASTIC LIGATURES (K891331) - FDA 510(k) Clearance

Class I Dental device.

K891331 · American Orthodontics · Dental device
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Oct 1989
Decision
220d
Days
Class 1
Risk

K891331 is an FDA 510(k) clearance for the UNI-STICK PLASTIC LIGATURES. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on October 16, 1989 after a review of 220 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 American Orthodontics devices

Submission Details

510(k) Number K891331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1989
Decision Date October 16, 1989
Days to Decision 220 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 127d · This submission: 220d
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.