Cleared Traditional

K923440 - APEX DIRECT BONDED BRACKETS

K923440 is an FDA 510(k) clearance for APEX DIRECT BONDED BRACKETS, manufactured by Apex Orthodontics, Inc.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K923440 · Apex Orthodontics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
261d
Days
Class 1
Risk

K923440 is an FDA 510(k) clearance for the APEX DIRECT BONDED BRACKETS. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Apex Orthodontics, Inc. (Desoto, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 261 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 Apex Orthodontics, Inc. devices

FDA 510(k) Submission Details - K923440

510(k) Number K923440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1992
Decision Date March 31, 1993
Days to Decision 261 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 127d · This submission: 261d
Pathway characteristics
Predicate-based equivalence.

EJF Device Classification - Class 1, General Controls

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 47
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K923440.
ORMCO SPORTSGUARD
K922806 · Ormco Corp. · Oct 1993
PLASTIC CHAIN
K925012 · American Orthodontics · Sep 1993
THE HERBST APPLIANCE
K923405 · Ormco Corp. · May 1993
ORTHODONTIC METAL BRACKET
K923261 · American Orthodontics · Dec 1992
GERMAN MINI DYNALOCK
K923432 · Unitek Corp. · Oct 1992
KLEER(TM) ORTHODONTIC BRACKET
K914616 · Ormco Corp. · Nov 1991