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510(k) K101545

GENESIS IMPLANT SYSTEM by Keystone Dental — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2010
Date Received
June 3, 2010
Clearance Type
Abbreviated
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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