Cleared Traditional

KORN MANDIBULAR ADVANCER

K893482 · American Orthodontics · Dental
Oct 1989
Decision
161d
Days
Class 1
Risk

About This 510(k) Submission

K893482 is an FDA 510(k) clearance for the KORN MANDIBULAR ADVANCER, a Bracket, Metal, Orthodontic (Class I — General Controls, product code EJF), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on October 12, 1989, 161 days after receiving the submission on May 4, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K893482 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1989
Decision Date October 12, 1989
Days to Decision 161 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EJF — Bracket, Metal, Orthodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5410