Cleared Traditional

DUCERAM PLUS CERAMIC SYSTEM

K040420 · Dentsply Intl. · Dental
Mar 2004
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K040420 is an FDA 510(k) clearance for the DUCERAM PLUS CERAMIC SYSTEM, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on March 18, 2004, 29 days after receiving the submission on February 18, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K040420 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2004
Decision Date March 18, 2004
Days to Decision 29 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

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