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510(k) K091387

BTI DENTAL IMPLANT 5.5-6.5 by B.T.I. Biotechnology Institute, Sl. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2010
Date Received
May 11, 2009
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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