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510(k) K223814

Genesis ACTIVE Implant System by Keystone Dental, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2023
Date Received
December 20, 2022
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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  • K071599 — EASYGUIDE (July 11, 2007)

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