Atlantis Suprastructures

Abutment, Implant, Dental, Endosseous

Dentsply Sirona Inc.

The following data is part of a premarket notification filed by Dentsply Sirona Inc. with the FDA for Atlantis Suprastructures.

Pre-market Notification Details

Device IDK193064
510k NumberK193064
Device Name:Atlantis Suprastructures
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Dentsply Sirona Inc. 221 West Philadelphia Street, Suite 60W York,  PA  17401
ContactKarl Nittinger
CorrespondentKarl Nittinger
Dentsply Sirona Inc. 221 West Philadelphia Street, Suite 60W York,  PA  17401
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-04
Decision Date2020-03-03

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