Cleared Traditional

CONQUEST DIRECT FILLING COMPOSITE (DFC) (K904724) - FDA 510(k) Clearance

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

K904724 · Jeneric/Pentron, Inc. · Dental device
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Dec 1990
Decision
51d
Days
Class 2
Risk

K904724 is an FDA 510(k) clearance for the CONQUEST DIRECT FILLING COMPOSITE (DFC). Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on December 7, 1990 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Jeneric/Pentron, Inc. devices

Submission Details

510(k) Number K904724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1990
Decision Date December 07, 1990
Days to Decision 51 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 127d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 122
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K904724.
SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM
K920424 · 3M Company · Mar 1992
SR-ISOSIT SPECTRA LINK SYSTEM
K910069 · Ivoclar North America, Inc. · Mar 1992
PRISMA UNIVERSAL BOND(R) 3
K915830 · Dentsply Intl. · Mar 1992
SYNTAC (DENTIN BONDING AGENT)
K901913 · Ivoclar North America, Inc. · Jun 1990
MODIFIED GLUMA BONDING SYSTEM
K896382 · Heraeus Kulzer, Inc. · Feb 1990
DENTIN PRIMER
K891455 · Dentsply Intl. · May 1989