Cleared Traditional

MEDION MI-200 IONTOPHORETIC MEDICATOR (K831000) - FDA 510(k) Clearance

K831000 · Etherington Industries · Dental device
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Aug 1983
Decision
132d
Days
-
Risk

K831000 is an FDA 510(k) clearance for the MEDION MI-200 IONTOPHORETIC MEDICATOR.

Submitted by Etherington Industries (Mchenry, US). The FDA issued a Cleared decision on August 8, 1983 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. 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.

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Submission Details

510(k) Number K831000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1983
Decision Date August 08, 1983
Days to Decision 132 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 127d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -