Cleared Traditional

K810913 - CAVITY VARNISH

K810913 is the FDA 510(k) clearance for CAVITY VARNISH by Dentsply Intl.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K810913 · Dentsply Intl. · Dental device
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Sep 1981
Decision
168d
Days
Class 2
Risk

K810913 is an FDA 510(k) clearance for the CAVITY VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1981 after a review of 168 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.

View all Dentsply Intl. devices

Submission Details

510(k) Number K810913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1981
Decision Date September 21, 1981
Days to Decision 168 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 127d · This submission: 168d
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 78
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K810913.
UNIVAR UNIVERSAL DENTIN VARNISH
K852755 · Scientific Pharmaceuticals, Inc. · Sep 1985
TELEDYNE GETZ BARRIER-DENTIN SEALER
K852756 · Scientific Pharmaceuticals, Inc. · Jul 1985
ACA THYROXINE ANALYTICAL TEST PACK
K833701 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1984
SCI-PHARM UNIVERSAL CAVITY VARNISH
K802926 · Scientific Pharmaceuticals, Inc. · Dec 1980
DENTAL CAVITY VARNISH, CONCENTRATED
K800438 · Scientific Pharmaceuticals, Inc. · Mar 1980