Cleared Traditional

K911231 - ORTHODONTIC WIRE

K911231 is an FDA 510(k) clearance for ORTHODONTIC WIRE, manufactured by Masel Industries, Inc.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K911231 · Masel Industries, Inc. · Dental device
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Oct 1991
Decision
202d
Days
Class 1
Risk

K911231 is an FDA 510(k) clearance for the ORTHODONTIC WIRE. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Masel Industries, Inc. (Bristol, US). The FDA issued a Cleared decision on October 8, 1991 after a review of 202 days - an extended review 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: 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 Masel Industries, Inc. devices

FDA 510(k) Submission Details - K911231

510(k) Number K911231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1991
Decision Date October 08, 1991
Days to Decision 202 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 127d · This submission: 202d
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 K911231.
ORTHODONTIC METAL BRACKET
K923261 · American Orthodontics · Dec 1992
GERMAN MINI DYNALOCK
K923432 · Unitek Corp. · Oct 1992
KLEER(TM) ORTHODONTIC BRACKET
K914616 · Ormco Corp. · Nov 1991
NONSTAINING ALASTIKS
K910288 · Unitek Corp. · Mar 1991
ENDOMETRIAL SAMPLER
K901896 · Kirwan Surgical Products, Inc. · Aug 1990
MODIFIED UNI-STICK PLASTIC LIGATURE
K902064 · American Orthodontics · Aug 1990