Cleared Special

K050880 - DYRACT EXTRA RESTORATIVE

K050880 is the FDA 510(k) clearance for DYRACT EXTRA RESTORATIVE by Dentsply Intl.. It is a Class 2 Dental device (product code EBF) cleared through the Special 510(k) pathway after a 16-day FDA review.

K050880 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
16d
Days
Class 2
Risk

K050880 is an FDA 510(k) clearance for the DYRACT EXTRA RESTORATIVE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on April 22, 2005 after a review of 16 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dentsply Intl. devices

Submission Details

510(k) Number K050880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2005
Decision Date April 22, 2005
Days to Decision 16 days
Submission Type Special
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
111d faster than avg
Panel avg: 127d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 587
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K050880.
GRANDIO
K051867 · Voco GmbH · Jul 2005
GRANDIO FLOW
K051868 · Voco GmbH · Jul 2005
CERAMAGE
K050401 · Shofu Dental Corp. · Apr 2005
TESCERA OPAQUER POWDER/SCULPTING RESIN
K042804 · Bisco, Inc. · Feb 2005
AMELOGEN PLUS
K043119 · Ultradent Products, Inc. · Dec 2004
CLEAFIL DC CORE AUTOMIX
K043177 · Kuraray Medical, Inc. · Dec 2004