Cleared Traditional

K945794 - DURAPHAT

K945794 is an FDA 510(k) clearance for DURAPHAT, manufactured by Inpharma. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K945794 · Inpharma · Dental device
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Jul 1995
Decision
243d
Days
Class 2
Risk

K945794 is an FDA 510(k) clearance for the DURAPHAT. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Inpharma (Boxton, US). The FDA issued a Cleared decision on July 26, 1995 after a review of 243 days - an extended review 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: 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.

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FDA 510(k) Submission Details - K945794

510(k) Number K945794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1994
Decision Date July 26, 1995
Days to Decision 243 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
116d slower than avg
Panel avg: 127d · This submission: 243d
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 K945794.
ALPHA-DENT COPAL CAVITY VARNISH
K955521 · Wallace A. Erickson & Co. · Jan 1996
ULTRACID DISINFECTING SOLOUTION
K953167 · Ultradent Products, Inc. · Sep 1995
ULTRACID F DISINFECTING SOLUTION
K953168 · Ultradent Products, Inc. · Sep 1995
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