Cleared Traditional

K891140 - OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISS...

K891140 is the FDA 510(k) clearance for OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISS... by Coe Laboratories, Inc.. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K891140 · Coe Laboratories, Inc. · Dental device
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May 1989
Decision
59d
Days
Class 2
Risk

K891140 is an FDA 510(k) clearance for the OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Coe Laboratories, Inc. (Alsip, US). The FDA issued a Cleared decision on May 1, 1989 after a review of 59 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 Coe Laboratories, Inc. devices

Submission Details

510(k) Number K891140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1989
Decision Date May 01, 1989
Days to Decision 59 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 127d · This submission: 59d
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 79
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K891140.
SEAL RITE(TM)
K902022 · Pulpdent Corp. · Jul 1990
SEAL RITE PROCEDURE KIT(TM)
K902023 · Pulpdent Corp. · Jul 1990
FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE
K896341 · Dentsply Intl. · Apr 1990
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT
K874944 · Dentsply Intl. · Feb 1988
BISCO PIT AND FISSURE SEALANT
K874556 · Bisco, Inc. · Jan 1988
BISCO PORCELAIN REPAIR KIT
K874557 · Bisco, Inc. · Jan 1988