Cleared Traditional

K893655 - KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK

K893655 is an FDA 510(k) clearance for KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK, manufactured by American Orthodontics. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 100-day FDA review.

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

K893655 is an FDA 510(k) clearance for the KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK. 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 August 23, 1989 after a review of 100 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K893655

510(k) Number K893655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1989
Decision Date August 23, 1989
Days to Decision 100 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
27d faster than avg
Panel avg: 127d · This submission: 100d
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 46
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K893655.
KORN MANDIBULAR ADVANCER
K893482 · American Orthodontics · Oct 1989
LUMINA ORTHODONTIC BRACKET
K894358 · Ormco Corp. · Sep 1989
OPTIFLEX
K894781 · Ormco Corp. · Sep 1989
BONDABLE RETAINER AND SPACE MAINTAINER
K893483 · American Orthodontics · Jul 1989
MULTIPHASE ORTHODONTIC WIRE
K893484 · American Orthodontics · Jul 1989
PLASTIC FORCE MODULE
K893550 · American Orthodontics · Jul 1989