Cleared Traditional

K881026 - CONTAC

K881026 is the FDA 510(k) clearance for CONTAC by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K881026 · Harry J. Bosworth Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1988
Decision
83d
Days
Class 2
Risk

K881026 is an FDA 510(k) clearance for the CONTAC, A DENTIN SEALANT. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on June 1, 1988 after a review of 83 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 Harry J. Bosworth Co. devices

Submission Details

510(k) Number K881026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1988
Decision Date June 01, 1988
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
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 65
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K881026.
COPAL VARNISH
K901049 · Pulpdent Corp. · May 1990
UNIVERSUM
K900946 · Scientific Pharmaceuticals, Inc. · May 1990
ESPE VARNISH
K880741 · Espe GmbH (Us) · Jul 1988
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