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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K251515
Device Name Solidex® Ti-Links and Screws
Applicant
CreoDent Hudson Valley
1769 Rt 52
Fishkill,  NY  12524
Applicant Contact Calvin Shim
Correspondent
CreoDent Hudson Valley
1769 Rt 52
Fishkill,  NY  12524
Correspondent Contact Calvin Shim
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received05/16/2025
Decision Date 02/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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