Cleared Traditional

KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK

K893655 · American Orthodontics · Dental
Aug 1989
Decision
100d
Days
Class 1
Risk

About This 510(k) Submission

K893655 is an FDA 510(k) clearance for the KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK, a Bracket, Metal, Orthodontic (Class I — General Controls, product code EJF), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on August 23, 1989, 100 days after receiving the submission on May 15, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K893655 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1989
Decision Date August 23, 1989
Days to Decision 100 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