Cleared Traditional

K840807 - THROAT MOI-STIR

K840807 · Kingswood Laboratories, Inc. · Dental device
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May 1984
Decision
91d
Days
-
Risk

K840807 is an FDA 510(k) clearance for the THROAT MOI-STIR. Classified as Saliva, Artificial (product code LFD).

Submitted by Kingswood Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1984 after a review of 91 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 Kingswood Laboratories, Inc. devices

FDA 510(k) Submission Details - K840807

510(k) Number K840807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date May 25, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 128d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -