Cleared Traditional

K923261 - ORTHODONTIC METAL BRACKET

K923261 is the FDA 510(k) clearance for ORTHODONTIC METAL BRACKET by American Orthodontics. It is a Class 1 Dental device (product code EJF) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K923261 · American Orthodontics · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
154d
Days
Class 1
Risk

K923261 is an FDA 510(k) clearance for the ORTHODONTIC METAL BRACKET. 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 December 3, 1992 after a review of 154 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 K923261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1992
Decision Date December 03, 1992
Days to Decision 154 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
27d slower than avg
Panel avg: 127d · This submission: 154d
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.

Regulatory Peers - EJF Bracket, Metal, Orthodontic

All 30
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K923261.
ORMCO SPORTSGUARD
K922806 · Ormco Corp. · Oct 1993
PLASTIC CHAIN
K925012 · American Orthodontics · Sep 1993
THE HERBST APPLIANCE
K923405 · Ormco Corp. · May 1993
KLEER(TM) ORTHODONTIC BRACKET
K914616 · Ormco Corp. · Nov 1991
MODIFIED UNI-STICK PLASTIC LIGATURE
K902064 · American Orthodontics · Aug 1990
MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE
K900488 · American Orthodontics · Jun 1990