Cleared Traditional

K944934 - POLYURETHANE SOLUTION 29% W/W

K944934 is an FDA 510(k) clearance for POLYURETHANE SOLUTION 29% W/W, manufactured by Knowell Therapeutic Technologies,Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K944934 · Knowell Therapeutic Technologies,Inc. · Dental device
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Dec 1994
Decision
64d
Days
Class 2
Risk

K944934 is an FDA 510(k) clearance for the POLYURETHANE SOLUTION 29% W/W. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Knowell Therapeutic Technologies,Inc. (Toronto, CA). The FDA issued a Cleared decision on December 9, 1994 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - the FDA dental device regulatory framework. 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 Knowell Therapeutic Technologies,Inc. devices

FDA 510(k) Submission Details - K944934

510(k) Number K944934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1994
Decision Date December 09, 1994
Days to Decision 64 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 127d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBH Device Classification - Class 2, Special Controls

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LBH Varnish, Cavity

All 115
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K944934.
ULTRACID DISINFECTING SOLOUTION
K953167 · Ultradent Products, Inc. · Sep 1995
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FLUOR PROTECTOR
K946032 · Ivoclar North America, Inc. · Mar 1995
BOSWORTH COPALIONER
K933505 · Harry J. Bosworth Co. · Jan 1994
CONSEPSIS SCRUB
K925375 · Ultradent Products, Inc. · Jul 1993
CONSEPSIS(TM)
K924982 · Ultradent Products, Inc. · Jul 1993