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510(k) K251515

Solidex® Ti-Links and Screws by CreoDent Hudson Valley — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2026
Date Received
May 16, 2025
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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