P.004 ABUTMENTS

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 P.004 Abutments.

Pre-market Notification Details

Device IDK072679
510k NumberK072679
Device Name:P.004 ABUTMENTS
ClassificationAbutment, Implant, Dental, Endosseous
Applicant INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover,  MA  01810
ContactElaine Alan
CorrespondentElaine Alan
INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover,  MA  01810
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-21
Decision Date2007-10-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630031710437 K072679 000
07630031710260 K072679 000

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