Atlantis Abutment For MIS Implant

Abutment, Implant, Dental, Endosseous

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Atlantis Abutment For Mis Implant.

Pre-market Notification Details

Device IDK172225
510k NumberK172225
Device Name:Atlantis Abutment For MIS Implant
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Dentsply Sirona 221 West Philadelphia Street Suite 60W York,  PA  17401
ContactKarl Nittinger
CorrespondentKarl Nittinger
Dentsply Sirona 221 West Philadelphia Street Suite 60W York,  PA  17401
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-25
Decision Date2017-11-30
Summary:summary

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