Cleared Traditional

COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE (K873605) - FDA 510(k) Clearance

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

Submission Details

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
10d faster than avg
Panel avg: 127d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LWM Device, Electrical Dental Anesthesia
Device Class -