Cleared Traditional

PIT AND FISSURE SEAANTS (K844308) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844308 · Dentsply Intl. · Dental device
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Jan 1985
Decision
64d
Days
Class 2
Risk

K844308 is an FDA 510(k) clearance for the PIT AND FISSURE SEAANTS. 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 January 9, 1985 after a review of 64 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 Dentsply Intl. devices

Submission Details

510(k) Number K844308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1984
Decision Date January 09, 1985
Days to Decision 64 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
63d faster than avg
Panel avg: 127d · This submission: 64d
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 24
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K844308.
FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE
K896341 · Dentsply Intl. · Apr 1990
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT
K874944 · Dentsply Intl. · Feb 1988
PRISMA METAL OPAQUERS
K862660 · Dentsply Intl. · Jul 1986
CONCISE LIGHT CURED WHITE SEALANT
K844211 · 3M Company · Jan 1985
DELTON * OPAQUE LIGHT CURING PIT
K842392 · Johnson & Johnson Professionals, Inc. · Jul 1984
DELTON LIGHT CURING PIT & FISSURE
K831380 · Johnson & Johnson Professionals, Inc. · Jun 1983