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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 K242929
Device Name Fas Aligner System
Applicant
Xplora 3D Europe S.L
C/ Juan De La Cierva 70
Arroyomolinos
Madrid,  ES 28939
Applicant Contact Esther Aznar
Correspondent
Compliance4Devices
118 W Prive Cr.
118 W Prive Cr.,  FL  33445
Correspondent Contact Juan Tezak
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/24/2024
Decision Date 12/20/2024
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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