DUCERAM PLUS CERAMIC SYSTEM

Powder, Porcelain

DENTSPLY INTL.

The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Duceram Plus Ceramic System.

Pre-market Notification Details

Device IDK040420
510k NumberK040420
Device Name:DUCERAM PLUS CERAMIC SYSTEM
ClassificationPowder, Porcelain
Applicant DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York,  PA  17404
ContactP. Jeffery Lehn
CorrespondentP. Jeffery Lehn
DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York,  PA  17404
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-18
Decision Date2004-03-18
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.