Cleared Traditional

K040144 - QUIXX POSTERIOR RESTORATIVE

K040144 is an FDA 510(k) clearance for QUIXX POSTERIOR RESTORATIVE, manufactured by Dentsply International. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K040144 · Dentsply International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
70d
Days
Class 2
Risk

K040144 is an FDA 510(k) clearance for the QUIXX POSTERIOR RESTORATIVE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dentsply International (York, US). The FDA issued a Cleared decision on April 1, 2004 after a review of 70 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 Dentsply International devices

FDA 510(k) Submission Details - K040144

510(k) Number K040144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2004
Decision Date April 01, 2004
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
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 K040144.
TETRIC EVOCERAM
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HERMES
K033996 · 3M Espe AG Dental Products · Feb 2004
GRADIA GUM
K033808 · GC America, Inc. · Feb 2004