Cleared Traditional

K896341 - FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT ...

K896341 is the FDA 510(k) clearance for FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT ... by Dentsply Intl.. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K896341 · Dentsply Intl. · Dental device
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Apr 1990
Decision
171d
Days
Class 2
Risk

K896341 is an FDA 510(k) clearance for the FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on April 23, 1990 after a review of 171 days - an extended review 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: 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 Dentsply Intl. devices

Submission Details

510(k) Number K896341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1989
Decision Date April 23, 1990
Days to Decision 171 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
44d slower than avg
Panel avg: 127d · This submission: 171d
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 77
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K896341.
DEGUFILL (TM) WHIT-SEALANT
K902742 · Degussa AG · Sep 1990
SEAL RITE(TM)
K902022 · Pulpdent Corp. · Jul 1990
SEAL RITE PROCEDURE KIT(TM)
K902023 · Pulpdent Corp. · Jul 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