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510(k) K142426

EBI External Implant System by Ebi, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2015
Date Received
August 29, 2014
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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