Cleared Traditional

K852755 - UNIVAR UNIVERSAL DENTIN VARNISH

K852755 is an FDA 510(k) clearance for UNIVAR UNIVERSAL DENTIN VARNISH, manufactured by Scientific Pharmaceuticals, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K852755 · Scientific Pharmaceuticals, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
87d
Days
Class 2
Risk

K852755 is an FDA 510(k) clearance for the UNIVAR UNIVERSAL DENTIN VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Duarte, US). The FDA issued a Cleared decision on September 23, 1985 after a review of 87 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.

FDA 510(k) Submission Details - K852755

510(k) Number K852755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1985
Decision Date September 23, 1985
Days to Decision 87 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 faster than avg
Panel avg: 128d · This submission: 87d
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 139
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K852755.
TUBULICID BLUE LABEL
K864050 · Dental Dimensions Supply Co. · Dec 1986
TUBULITEC PRIMER
K864052 · Dental Dimensions Supply Co. · Dec 1986
FLUOROSEAL, DENTIN SEALER AND CAVITY LINER
K860633 · Scientific Pharmaceuticals, Inc. · Apr 1986
TUBULITEC PRIMER
K851052 · Dental Therapeutics AB · Jul 1985
TELEDYNE GETZ BARRIER-DENTIN SEALER
K852756 · Scientific Pharmaceuticals, Inc. · Jul 1985
TEMREX-DENTIN VARNISH
K851030 · Temrex Corp. · Jun 1985
K852755 · UNIVAR UNIVERSAL DENTIN VARNISH
Download PDF Scientific Pharmaceut…