Cleared Traditional

K810913 - CAVITY VARNISH

K810913 is an FDA 510(k) clearance for CAVITY VARNISH, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K810913

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.

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 111
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K810913.
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
CAVITY CLEANSER
K832497 · Den-Mat Corp. · Oct 1983
SCI-PHARM UNIVERSAL CAVITY VARNISH
K802926 · Scientific Pharmaceuticals, Inc. · Dec 1980
DENTAL CAVITY VARNISH, CONCENTRATED
K800438 · Scientific Pharmaceuticals, Inc. · Mar 1980