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510(k) K133049

3I T3(R) EXTERNAL HEX DENTAL IMPLANTS by Biomet 3i — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2014
Date Received
September 27, 2013
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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