Cleared Traditional

THE MYOLOC SYSTEM (K900678) - FDA 510(k) Clearance

Class I Dental device.

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

Submission Details

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.

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.