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510(k) K070483

LEONE MONOIMPLANT FOR O-RING OVERDENTURE by Leone S.P.A. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2007
Date Received
February 20, 2007
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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