Cleared Traditional

K983751 - QUADRANT UNICHEM

K983751 is an FDA 510(k) clearance for QUADRANT UNICHEM, 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 38-day FDA review.

K983751 · Cavex Holland BV · Dental device
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Nov 1998
Decision
38d
Days
Class 2
Risk

K983751 is an FDA 510(k) clearance for the QUADRANT UNICHEM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Cavex Holland BV (Haarlem, NL). The FDA issued a Cleared decision on November 30, 1998 after a review of 38 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 - K983751

510(k) Number K983751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1998
Decision Date November 30, 1998
Days to Decision 38 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
89d faster than avg
Panel avg: 127d · This submission: 38d
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 K983751.
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
QUADRANT ANTERIOR SHINE
K983549 · Cavex Holland BV · Nov 1998
PRODIGY- 3
K983370 · Sybron Dental Specialties, Inc. · Nov 1998
LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
K980800 · Cosmedent, Inc. · Nov 1998