Cleared Traditional

K851030 - TEMREX-DENTIN VARNISH

K851030 is an FDA 510(k) clearance for TEMREX-DENTIN VARNISH, manufactured by Temrex Corp.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K851030 · Temrex Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
100d
Days
Class 2
Risk

K851030 is an FDA 510(k) clearance for the TEMREX-DENTIN VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Temrex Corp. (Duarte, US). The FDA issued a Cleared decision on June 20, 1985 after a review of 100 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 Temrex Corp. devices

FDA 510(k) Submission Details - K851030

510(k) Number K851030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1985
Decision Date June 20, 1985
Days to Decision 100 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 127d · This submission: 100d
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 112
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K851030.
FLUOROSEAL, DENTIN SEALER AND CAVITY LINER
K860633 · Scientific Pharmaceuticals, Inc. · Apr 1986
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
CAVITY CLEANSER
K832497 · Den-Mat Corp. · Oct 1983
CAVITY VARNISH
K810913 · Dentsply Intl. · Sep 1981