Cleared Traditional

K901957 - MUSTANG

K901957 is the FDA 510(k) clearance for MUSTANG by Lancer Orthodontics, Inc.. It is a Class 1 Dental device (product code EJF) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K901957 · Lancer Orthodontics, Inc. · Dental device
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Jul 1990
Decision
90d
Days
Class 1
Risk

K901957 is an FDA 510(k) clearance for the MUSTANG, C.A.T.. 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 July 30, 1990 after a review of 90 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 Lancer Orthodontics, Inc. devices

Submission Details

510(k) Number K901957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1990
Decision Date July 30, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 23
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K901957.
PLASTIC CHAIN
K925012 · American Orthodontics · Sep 1993
ORTHODONTIC METAL BRACKET
K923261 · American Orthodontics · Dec 1992
MODIFIED UNI-STICK PLASTIC LIGATURE
K902064 · American Orthodontics · Aug 1990
MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE
K900488 · American Orthodontics · Jun 1990
STAINLESS STEEL DENTAL WIRES AND CLASPS
K901024 · Ivoclar North America, Inc. · Apr 1990
UNI-STICK PLASTIC LIGATURES
K891331 · American Orthodontics · Oct 1989