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510(k) K212533

BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants by Institut Straumann AG — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2022
Date Received
August 11, 2021
Clearance Type
Traditional
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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