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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K260527
Device Name FACE4D Aligner
Applicant
Avinent Implant System S.L.U.
Carretera De Navarcles, 107 Pol. Ind. Santa Anna I
Santpedor
Barcelona,  ES 08251
Applicant Contact Anna Cortina
Correspondent
Blackwell Device Consulting
P.O. Box 718
Gresham,  OR  97030
Correspondent Contact Angela Blackwell
Regulation Number872.5470
Classification Product Code
NXC  
Date Received02/17/2026
Decision Date 07/02/2026
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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