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510(k) K132212

DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL by Hager& Meisinger GmbH — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2014
Date Received
July 16, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Intraosseous
Device Class
Class II
Regulation Number
872.4880
Review Panel
DE
Submission Type

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