Cleared Traditional

THROAT MOI-STIR (K840807) - FDA 510(k) Clearance

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

Submission Details

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
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 16
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