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510(k) K241063

s-Clean ScanHealing Abutment by Dentis Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2024
Date Received
April 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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  • K230523 — s-Clean Link Abutment Narrow (May 24, 2023)
  • K230203 — Dentis I-FIX Abutment (May 3, 2023)

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