Cleared Traditional

K844211 - CONCISE LIGHT CURED WHITE SEALANT

K844211 is the FDA 510(k) clearance for CONCISE LIGHT CURED WHITE SEALANT by 3M Company. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K844211 · 3M Company · Dental device
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Jan 1985
Decision
68d
Days
Class 2
Risk

K844211 is an FDA 510(k) clearance for the CONCISE LIGHT CURED WHITE SEALANT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on January 7, 1985 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 3M Company devices

Submission Details

510(k) Number K844211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1984
Decision Date January 07, 1985
Days to Decision 68 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
59d faster than avg
Panel avg: 127d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 62
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K844211.
PRISMA METAL OPAQUERS
K862660 · Dentsply Intl. · Jul 1986
SEALITE
K862284 · Sybron Corp. · Jun 1986
PIT AND FISSURE SEAANTS
K844308 · Dentsply Intl. · Jan 1985
APCO FISSURE SEALER & BONDING AGENT
K843098 · Scientific Pharmaceuticals, Inc. · Sep 1984
DELTON * OPAQUE LIGHT CURING PIT
K842392 · Johnson & Johnson Professionals, Inc. · Jul 1984
DELTON LIGHT CURING PIT & FISSURE
K831380 · Johnson & Johnson Professionals, Inc. · Jun 1983