Cleared Traditional

K902948 - COMFORTRON II (TENS) (FDA 510(k) Clearance)

K902948 · M. D. Products · Dental device
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Dec 1990
Decision
165d
Days
-
Risk

K902948 is an FDA 510(k) clearance for the COMFORTRON II (TENS). Classified as Device, Electrical Dental Anesthesia (product code LWM).

Submitted by M. D. Products (Ocala, US). The FDA issued a Cleared decision on December 17, 1990 after a review of 165 days - an extended review cycle.

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 K902948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1990
Decision Date December 17, 1990
Days to Decision 165 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 127d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LWM Device, Electrical Dental Anesthesia
Device Class -