Cleared Traditional

ORTHODONTIC PLASTIC BRACKET (K891372) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K891372 · American Orthodontics · Dental device
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Mar 1989
Decision
22d
Days
Class 2
Risk

K891372 is an FDA 510(k) clearance for the ORTHODONTIC PLASTIC BRACKET. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on March 31, 1989 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - 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 American Orthodontics devices

Submission Details

510(k) Number K891372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1989
Decision Date March 31, 1989
Days to Decision 22 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 127d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYW Bracket, Plastic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DYW Bracket, Plastic, Orthodontic

All 41
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K891372.
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