Cleared Traditional

K810157 - MOI-STIR

K810157 · Kingswood Laboratories, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1981
Decision
20d
Days
-
Risk

K810157 is an FDA 510(k) clearance for the MOI-STIR. Classified as Saliva, Artificial (product code LFD).

Submitted by Kingswood Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1981 after a review of 20 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kingswood Laboratories, Inc. devices

FDA 510(k) Submission Details - K810157

510(k) Number K810157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1981
Decision Date February 10, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 128d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -