Cleared Traditional

K923405 - THE HERBST APPLIANCE

K923405 is an FDA 510(k) clearance for THE HERBST APPLIANCE, manufactured by Ormco Corp.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K923405 · Ormco Corp. · Dental device
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May 1993
Decision
299d
Days
Class 1
Risk

K923405 is an FDA 510(k) clearance for the THE HERBST APPLIANCE. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Ormco Corp. (Glendora, US). The FDA issued a Cleared decision on May 5, 1993 after a review of 299 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 Ormco Corp. devices

FDA 510(k) Submission Details - K923405

510(k) Number K923405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1992
Decision Date May 05, 1993
Days to Decision 299 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
172d slower than avg
Panel avg: 127d · This submission: 299d
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 45
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K923405.
DENTAURUM METAL BRACKETS
K935122 · Dentauraum, Inc. · Jan 1994
ORMCO SPORTSGUARD
K922806 · Ormco Corp. · Oct 1993
PLASTIC CHAIN
K925012 · American Orthodontics · Sep 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