Cleared Traditional

K880741 - ESPE VARNISH

K880741 is an FDA 510(k) clearance for ESPE VARNISH, manufactured by Espe GmbH (Us). The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K880741 · Espe GmbH (Us) · Dental device
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Jul 1988
Decision
128d
Days
Class 2
Risk

K880741 is an FDA 510(k) clearance for the ESPE VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 128 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 Espe GmbH (Us) devices

FDA 510(k) Submission Details - K880741

510(k) Number K880741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1988
Decision Date July 01, 1988
Days to Decision 128 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
1d slower than avg
Panel avg: 127d · This submission: 128d
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 93
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K880741.
DENTIN PROTECTOR
K901915 · Ivoclar North America, Inc. · Jun 1990
COPAL VARNISH
K901049 · Pulpdent Corp. · May 1990
UNIVERSUM
K900946 · Scientific Pharmaceuticals, Inc. · May 1990
CONTAC, A DENTIN SEALANT
K881026 · Harry J. Bosworth Co. · Jun 1988
FLUOROSEAL, DENTIN SEALER AND CAVITY LINER
K860633 · Scientific Pharmaceuticals, Inc. · Apr 1986
UNIVAR UNIVERSAL DENTIN VARNISH
K852755 · Scientific Pharmaceuticals, Inc. · Sep 1985