Cleared Traditional

K873605 - COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE

K873605 · Pain Prevention Laboratory, Inc. · Dental device
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Dec 1987
Decision
117d
Days
-
Risk

K873605 is an FDA 510(k) clearance for the COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE. Classified as Device, Electrical Dental Anesthesia (product code LWM).

Submitted by Pain Prevention Laboratory, Inc. (Northbrook, US). The FDA issued a Cleared decision on December 30, 1987 after a review of 117 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.

View all Pain Prevention Laboratory, Inc. devices

FDA 510(k) Submission Details - K873605

510(k) Number K873605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1987
Decision Date December 30, 1987
Days to Decision 117 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 128d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

LWM Device Classification - Class 0,

Product Code LWM Device, Electrical Dental Anesthesia
Device Class -