Cleared Traditional

K896341 - FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE

K896341 is an FDA 510(k) clearance for FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT ..., manufactured by Dentsply Intl.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K896341

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.

EBC Device Classification - Class 2, Special Controls

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 106
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
TEETHMATE-A
K897027 · Kuraray Co. · Mar 1990
OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT
K891140 · Coe Laboratories, Inc. · May 1989
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT
K874944 · Dentsply Intl. · Feb 1988