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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K220329
Device Name G-CAM
Applicant
Graphenano Dental S.L.
C/ Pablo Casals , 13 Ba.
Yecla,  ES 30510
Applicant Contact Maria Simon Garcia
Correspondent
Graphenano Dental S.L.
C/ Pablo Casals , 13 Ba.
Yecla,  ES 30510
Correspondent Contact Maria Simon Garcia
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Codes
EBG   EBI  
Date Received02/04/2022
Decision Date 08/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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