Cleared Traditional

ORTHOMAG MAGNETIC FORCE SYSTEM (K843550) - FDA 510(k) Clearance

Class I Dental device.

K843550 · Medical Magnetics, Inc. · Dental device
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Dec 1984
Decision
102d
Days
Class 1
Risk

K843550 is an FDA 510(k) clearance for the ORTHOMAG MAGNETIC FORCE SYSTEM. Classified as Spring, Orthodontic (product code ECO), Class I - General Controls.

Submitted by Medical Magnetics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 21, 1984 after a review of 102 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 Medical Magnetics, Inc. devices

Submission Details

510(k) Number K843550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1984
Decision Date December 21, 1984
Days to Decision 102 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 127d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECO Spring, 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.