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510(k) K053355

BTI INTERNA DENTAL IMPLANT SYSTEM by B.T.I. Biotechnology Institute, Sl. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2006
Date Received
December 2, 2005
Clearance Type
Special
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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