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510(k) K252731

Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant by Promimic AB — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2026
Date Received
August 28, 2025
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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