P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS

Abutment, Implant, Dental, Endosseous

STRAUMANN MANUFACTURING, INC.

The following data is part of a premarket notification filed by Straumann Manufacturing, Inc. with the FDA for P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings.

Pre-market Notification Details

Device IDK080239
510k NumberK080239
Device Name:P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS
ClassificationAbutment, Implant, Dental, Endosseous
Applicant STRAUMANN MANUFACTURING, INC. 60 MINUTEMAN RD. Andover,  MA  01810
ContactElaine Alan
CorrespondentElaine Alan
STRAUMANN MANUFACTURING, INC. 60 MINUTEMAN RD. Andover,  MA  01810
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-31
Decision Date2008-04-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630031708151 K080239 000
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07630031711052 K080239 000

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