Cleared Traditional

K963979 - ULTRADENT UNIVERSAL DENTIN SEALANT

K963979 is the FDA 510(k) clearance for ULTRADENT UNIVERSAL DENTIN SEALANT by Ultradent Products, Inc.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K963979 · Ultradent Products, Inc. · Dental device
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Dec 1996
Decision
70d
Days
Class 2
Risk

K963979 is an FDA 510(k) clearance for the ULTRADENT UNIVERSAL DENTIN SEALANT. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 12, 1996 after a review of 70 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 Ultradent Products, Inc. devices

Submission Details

510(k) Number K963979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1996
Decision Date December 12, 1996
Days to Decision 70 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
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 70
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K963979.
GREEN-OR DENTIN DESENSITIZER
K981972 · Centrix, Inc. · Dec 1998
PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS
K974202 · Pulpdent Corp. · Mar 1998
PULPDENT CAVITY VARNISH
K974398 · Pulpdent Corp. · Feb 1998
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