Cleared Traditional

K884586 - COMFORTRON DENTAL ANESTHESIA APPARATUS (FDA 510(k) Clearance)

K884586 · M. D. Products · Dental device
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Apr 1989
Decision
163d
Days
-
Risk

K884586 is an FDA 510(k) clearance for the COMFORTRON DENTAL ANESTHESIA APPARATUS. Classified as Device, Electrical Dental Anesthesia (product code LWM).

Submitted by M. D. Products (Ocala, US). The FDA issued a Cleared decision on April 14, 1989 after a review of 163 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 K884586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1988
Decision Date April 14, 1989
Days to Decision 163 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 127d · This submission: 163d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LWM Device, Electrical Dental Anesthesia
Device Class -