STRAUMANN DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

INSTITUT STRAUMANN AG

The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Dental Implant System.

Pre-market Notification Details

Device IDK081419
510k NumberK081419
Device Name:STRAUMANN DENTAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover,  MA  01810
ContactLisa Quaglia
CorrespondentLisa Quaglia
INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover,  MA  01810
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-20
Decision Date2009-02-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630031716507 K081419 000
07630031716491 K081419 000
07630031716484 K081419 000
07630031716477 K081419 000

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