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510(k) K180365

PRAMA White Implant Systems by Sweden & Martina S.P.A. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2019
Date Received
February 12, 2018
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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