Cleared Traditional

K894358 - LUMINA ORTHODONTIC BRACKET

K894358 is an FDA 510(k) clearance for LUMINA ORTHODONTIC BRACKET, manufactured by Ormco Corp.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K894358 · Ormco Corp. · Dental device
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Sep 1989
Decision
63d
Days
Class 1
Risk

K894358 is an FDA 510(k) clearance for the LUMINA ORTHODONTIC BRACKET. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Ormco Corp. (Glendora, US). The FDA issued a Cleared decision on September 15, 1989 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ormco Corp. devices

FDA 510(k) Submission Details - K894358

510(k) Number K894358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1989
Decision Date September 15, 1989
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 45
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K894358.
LINGUAL SHEATH
K900184 · Ormco Corp. · Apr 1990
UNI-STICK PLASTIC LIGATURES
K891331 · American Orthodontics · Oct 1989
KORN MANDIBULAR ADVANCER
K893482 · American Orthodontics · Oct 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