Cleared Traditional

K891982 - J1 ATTACHMENT (ORTHODONTIC APPLIANCE)

K891982 is an FDA 510(k) clearance for J1 ATTACHMENT (ORTHODONTIC APPLIANCE), manufactured by T.M.K. Dental Products. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K891982 · T.M.K. Dental Products · Dental device
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Jul 1989
Decision
108d
Days
Class 1
Risk

K891982 is an FDA 510(k) clearance for the J1 ATTACHMENT (ORTHODONTIC APPLIANCE). Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by T.M.K. Dental Products (Castro Valley, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 108 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 T.M.K. Dental Products devices

FDA 510(k) Submission Details - K891982

510(k) Number K891982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1989
Decision Date July 14, 1989
Days to Decision 108 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 127d · This submission: 108d
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 47
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K891982.
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
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