ATLANTIS Suprastructures

Abutment, Implant, Dental, Endosseous

Dentsply Sirona

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

Pre-market Notification Details

Device IDK163398
510k NumberK163398
Device Name:ATLANTIS Suprastructures
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Dentsply Sirona 221 West Philadelphia Street, Suite 60 York,  PA  17404
ContactKarl Nittinger
CorrespondentKarl Nittinger
Dentsply Sirona 221 West Philadelphia Street, Suite 60 York,  PA  17404
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-05
Decision Date2017-08-14

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