Cleared Traditional

K901049 - COPAL VARNISH

K901049 is the FDA 510(k) clearance for COPAL VARNISH by Pulpdent Corp.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K901049 · Pulpdent Corp. · Dental device
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May 1990
Decision
85d
Days
Class 2
Risk

K901049 is an FDA 510(k) clearance for the COPAL VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on May 29, 1990 after a review of 85 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 Pulpdent Corp. devices

Submission Details

510(k) Number K901049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1990
Decision Date May 29, 1990
Days to Decision 85 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
42d faster than avg
Panel avg: 127d · This submission: 85d
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 K901049.
CONSEPSIS SCRUB
K925375 · Ultradent Products, Inc. · Jul 1993
CONSEPSIS(TM)
K924982 · Ultradent Products, Inc. · Jul 1993
DENTIN PROTECTOR
K901915 · Ivoclar North America, Inc. · Jun 1990
UNIVERSUM
K900946 · Scientific Pharmaceuticals, Inc. · May 1990
ESPE VARNISH
K880741 · Espe GmbH (Us) · Jul 1988
CONTAC, A DENTIN SEALANT
K881026 · Harry J. Bosworth Co. · Jun 1988