ATLANTIS Abutment For MIS Conical Connection Implants

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 Conical Connection Implants.

Pre-market Notification Details

Device IDK193529
510k NumberK193529
Device Name:ATLANTIS Abutment For MIS Conical Connection Implants
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)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-03-05

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