Cleared Traditional

K961893 - DURAFLOR

K961893 is an FDA 510(k) clearance for DURAFLOR, manufactured by Pharmascience, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K961893 · Pharmascience, Inc. · Dental device
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Aug 1996
Decision
90d
Days
Class 2
Risk

K961893 is an FDA 510(k) clearance for the DURAFLOR. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Pharmascience, Inc. (Severn, US). The FDA issued a Cleared decision on August 14, 1996 after a review of 90 days - within the typical 510(k) review window.

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.

View all Pharmascience, Inc. devices

FDA 510(k) Submission Details - K961893

510(k) Number K961893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1996
Decision Date August 14, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 101
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K961893.
PULPDENT CAVITY VARNISH
K974398 · Pulpdent Corp. · Feb 1998
CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)
K973919 · Medental Intl. · Dec 1997
ULTRADENT UNIVERSAL DENTIN SEALANT
K963979 · Ultradent Products, Inc. · Dec 1996
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