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510(k) K243834

NobelZygoma TiUltra Implant system by Nobel Biocare AB — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2025
Date Received
December 13, 2024
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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