Straumann CARES P-Series CAD/CAM System

Abutment, Implant, Dental, Endosseous

Institut Straumann AG

The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Cares P-series Cad/cam System.

Pre-market Notification Details

Device IDK203750
510k NumberK203750
Device Name:Straumann CARES P-Series CAD/CAM System
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Institut Straumann AG Peter Merien-Weg 12 Basel,  CH Ch-4002
ContactGordon Dodds
CorrespondentJennifer M Jackson
Straumann USA, LLC 60 Minuteman Road Andover,  MA  01801
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-23
Decision Date2021-10-09

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.