MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS

Implant, Endosseous, Root-form

STRAUMANN MANUFACTURING, INC.

The following data is part of a premarket notification filed by Straumann Manufacturing, Inc. with the FDA for Modification To:straumann Guided Instruments.

Pre-market Notification Details

Device IDK090260
510k NumberK090260
Device Name:MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS
ClassificationImplant, Endosseous, Root-form
Applicant STRAUMANN MANUFACTURING, INC. 60 MINUTEMAN RD. Andover,  MA  01810
ContactElaine Alan
CorrespondentElaine Alan
STRAUMANN MANUFACTURING, INC. 60 MINUTEMAN RD. Andover,  MA  01810
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-03
Decision Date2009-02-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630031716552 K090260 000
07630031714688 K090260 000
07630031714664 K090260 000
07630031714558 K090260 000
07630031714534 K090260 000
07630031714510 K090260 000
07630031707222 K090260 000
07630031707208 K090260 000
07630031707185 K090260 000
07630031706812 K090260 000
07630031706799 K090260 000
07630031714701 K090260 000
07630031714916 K090260 000
07630031716538 K090260 000
07630031716514 K090260 000
07630031715678 K090260 000
07630031715654 K090260 000
07630031715630 K090260 000
07630031715593 K090260 000
07630031715579 K090260 000
07630031715555 K090260 000
07630031714954 K090260 000
07630031714930 K090260 000
07630031706775 K090260 000

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