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510(k) K233271

OsseOne Dental Implant System by Synoross Dba Osseone — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2025
Date Received
September 29, 2023
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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