Cleared Traditional

K893482 - KORN MANDIBULAR ADVANCER

K893482 is the FDA 510(k) clearance for KORN MANDIBULAR ADVANCER by American Orthodontics. It is a Class 1 Dental device (product code EJF) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K893482 · American Orthodontics · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
161d
Days
Class 1
Risk

K893482 is an FDA 510(k) clearance for the KORN MANDIBULAR ADVANCER. 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 12, 1989 after a review of 161 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 K893482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1989
Decision Date October 12, 1989
Days to Decision 161 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 127d · This submission: 161d
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 K893482.
STAINLESS STEEL DENTAL WIRES AND CLASPS
K901024 · Ivoclar North America, Inc. · Apr 1990
LINGUAL SHEATH
K900184 · Ormco Corp. · Apr 1990
UNI-STICK PLASTIC LIGATURES
K891331 · American Orthodontics · Oct 1989
LUMINA ORTHODONTIC BRACKET
K894358 · Ormco Corp. · Sep 1989
OPTIFLEX
K894781 · Ormco Corp. · Sep 1989
KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK
K893655 · American Orthodontics · Aug 1989