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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 K253253
Device Name IPDmilled Blanks
Applicant
Implant Protesis Dental 2004, S.L.
Carrer Rosa Dels Vents, 9-15.
Premià De Dalt (Barcelona),  ES 08338
Applicant Contact Francesc Fumanal
Correspondent
Implant Protesis Dental 2004, S.L.
Carrer Rosa Dels Vents, 9-15.
Premià De Dalt (Barcelona),  ES 08338
Correspondent Contact Francesc Fumanal
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received09/29/2025
Decision Date 01/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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