Cleared Traditional

K984044 - QUADRANT POSTERIOR DENSE

K984044 is an FDA 510(k) clearance for QUADRANT POSTERIOR DENSE, manufactured by Cavex Holland BV. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K984044 · Cavex Holland BV · Dental device
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Dec 1998
Decision
33d
Days
Class 2
Risk

K984044 is an FDA 510(k) clearance for the QUADRANT POSTERIOR DENSE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Cavex Holland BV (Harmen, NL). The FDA issued a Cleared decision on December 16, 1998 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Cavex Holland BV devices

FDA 510(k) Submission Details - K984044

510(k) Number K984044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1998
Decision Date December 16, 1998
Days to Decision 33 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 127d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 645
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K984044.
MONOPAQUE
K990315 · Ivoclar North America, Inc. · Mar 1999
R-30 AESTHETIC RESTORATIVE
K984387 · Dentsply Intl. · Jan 1999
ADVENT
K984112 · Bisco, Inc. · Dec 1998
QUADRANT UNIVERSAL LC
K984041 · Cavex Holland BV · Dec 1998
QUADRANT CORE LC
K984042 · Cavex Holland BV · Dec 1998
QUADRANT TOTAL ETCH
K984043 · Cavex Holland BV · Dec 1998