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FDA 510(k) Application Details - K220329
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K220329
Device Name
Material, Tooth Shade, Resin
Applicant
Graphenano Dental S.L.
C/ Pablo Casals , 13 Ba.
Yecla 30510 ES
Other 510(k) Applications for this Company
Contact
Maria Simon Garcia
Other 510(k) Applications for this Contact
Regulation Number
872.3690
More FDA Info for this Regulation Number
Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/04/2022
Decision Date
08/16/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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