Cleared Traditional

K900678 - THE MYOLOC SYSTEM

K900678 is an FDA 510(k) clearance for THE MYOLOC SYSTEM, manufactured by Winder Research, Inc.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K900678 · Winder Research, Inc. · Dental device
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Aug 1990
Decision
181d
Days
Class 1
Risk

K900678 is an FDA 510(k) clearance for the THE MYOLOC SYSTEM. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Winder Research, Inc. (Tampa, US). The FDA issued a Cleared decision on August 13, 1990 after a review of 181 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 Winder Research, Inc. devices

FDA 510(k) Submission Details - K900678

510(k) Number K900678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1990
Decision Date August 13, 1990
Days to Decision 181 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 127d · This submission: 181d
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 K900678.
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
MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE
K900488 · American Orthodontics · Jun 1990