Cleared Traditional

K843550 - ORTHOMAG MAGNETIC FORCE SYSTEM

K843550 is an FDA 510(k) clearance for ORTHOMAG MAGNETIC FORCE SYSTEM, manufactured by Medical Magnetics, Inc.. The device is a Class 1 Dental device with product code ECO cleared through the Traditional 510(k) pathway after a 102-day FDA review.

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

FDA 510(k) Submission Details - K843550

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
26d faster than avg
Panel avg: 128d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

ECO Device Classification - Class 1, General Controls

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.