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510(k) K090260

MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS by Straumann Manufacturing, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2009
Date Received
February 3, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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  • K070478 — P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) (September 20, 2007)

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