Cleared Traditional

K904091 - TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO

K904091 is an FDA 510(k) clearance for TITANAL, manufactured by Lancer Orthodontics, Inc.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K904091 · Lancer Orthodontics, Inc. · Dental device
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Nov 1990
Decision
60d
Days
Class 1
Risk

K904091 is an FDA 510(k) clearance for the TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Lancer Orthodontics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 5, 1990 after a review of 60 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.

FDA 510(k) Submission Details - K904091

510(k) Number K904091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date November 05, 1990
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 128d · This submission: 60d
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 102
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K904091.
BRACKET, METAL, ORTHODOTNIC
K902809 · Masel Industries, Inc. · Dec 1990
LANCER ORIGINAL, SIERRA, GENERAL PURPOSE
K904092 · Lancer Orthodontics, Inc. · Nov 1990
BUCCAL TUBE, BUCCAL ATTACHMENT
K904093 · Lancer Orthodontics, Inc. · Nov 1990
PERMA MESH
K904089 · Lancer Orthodontics, Inc. · Nov 1990
C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE
K904094 · Lancer Orthodontics, Inc. · Nov 1990
NICKEL-TITANIUM ORTHODONTIC TOOTH SEPARATING SPRIN
K902844 · Progressive Dental Supply · Sep 1990
K904091 · TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO
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