Cleared Special

DYRACT EXTRA RESTORATIVE

K050880 · Dentsply Intl. · Dental
Apr 2005
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K050880 is an FDA 510(k) clearance for the DYRACT EXTRA RESTORATIVE, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on April 22, 2005, 16 days after receiving the submission on April 6, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K050880 FDA.gov
FDA Decision Cleared 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

Device Classification

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