ATLANTIS Crown

Powder, Porcelain

DENTSPLY INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Atlantis Crown.

Pre-market Notification Details

Device IDK152247
510k NumberK152247
Device Name:ATLANTIS Crown
ClassificationPowder, Porcelain
Applicant DENTSPLY INTERNATIONAL, INC. 221 WEST PHILADELPHIA ST. SUITE 60 York,  PA  17401
ContactHelen Lewis
CorrespondentHelen Lewis
DENTSPLY INTERNATIONAL, INC. 221 WEST PHILADELPHIA ST. SUITE 60 York,  PA  17401
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-10
Decision Date2016-01-29
Summary:summary

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