Cleared Traditional

K840751 - OPAQUE COATING & SURFACE STAIN

K840751 is the FDA 510(k) clearance for OPAQUE COATING & SURFACE STAIN by Dentsply Intl.. It is a Class 2 Dental device (product code EBD) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K840751 · Dentsply Intl. · Dental device
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May 1984
Decision
78d
Days
Class 2
Risk

K840751 is an FDA 510(k) clearance for the OPAQUE COATING & SURFACE STAIN. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on May 11, 1984 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Dentsply Intl. devices

Submission Details

510(k) Number K840751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1984
Decision Date May 11, 1984
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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 - EBD Coating, Filling Material, Resin

All 33
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K840751.
CURAY JOIN DENT DENTIN PRIMER
K850675 · Scientific Pharmaceuticals, Inc. · Mar 1985
CAULK DYCAL LIGHT CURED
K850641 · Dentsply Intl. · Mar 1985
J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT
K850073 · Johnson & Johnson Professionals, Inc. · Feb 1985
CONCISE 2 SMALL PARTICLE LIGHT CURVED
K832834 · 3M Company · Sep 1983
CBM, CORE BUILD-UP MATERIAL
K823732 · Scientific Pharmaceuticals, Inc. · Dec 1982
COMMAND BONDING RESIN/GLAZE/OPAQUER
K822869 · Sybron Corp. · Oct 1982