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510(k) K102034

BLUE SKY BIO DENTAL IMPLANT SYSTEM by Blue Sky Bio, LLC — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2011
Date Received
July 19, 2010
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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