CERA F ALLOY

Alloy, Gold-based Noble Metal

DENTSPLY INTERNATIONAL

The following data is part of a premarket notification filed by Dentsply International with the FDA for Cera F Alloy.

Pre-market Notification Details

Device IDK032321
510k NumberK032321
Device Name:CERA F ALLOY
ClassificationAlloy, Gold-based Noble Metal
Applicant DENTSPLY INTERNATIONAL 570 WEST COLLEGE AVE. P.O. BOX 872 York,  PA  17405 -0872
ContactP. Jeffery Lehn
CorrespondentP. Jeffery Lehn
DENTSPLY INTERNATIONAL 570 WEST COLLEGE AVE. P.O. BOX 872 York,  PA  17405 -0872
Product CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-28
Decision Date2003-09-30
Summary:summary

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