EBF — Material, Tooth Shade, Resin Class II

FDA Device Classification

Classification Details

Product Code
EBF
Device Class
Class II
Regulation Number
872.3690
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K261246gc americaSRGC-06June 18, 2026
K261093diadent group internationalDIAFILJune 2, 2026
K261071diadent group internationalDIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL BulMay 19, 2026
K260805vericom coDual CoreMay 11, 2026
K261357vocoGrandio disc multicolorApril 27, 2026
K261356hangzhou shining3d dental technology coDura-CrownApril 27, 2026
K260152mmtech projetos tecnologicos importacao e exportacao ltdaSmart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)April 23, 2026
K260661sprintrayMidas RestoreApril 15, 2026
K253036aidite (qinhuangdao) technology coLight-curing Coloring Materials (ALCM)April 6, 2026
K260783kulzerVenus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneMarch 11, 2026
K254245new steticZAFIRA®March 3, 2026
K260170hangzhou shining3d dental technology coLumiCeraJanuary 21, 2026
K252465mediclus coAny-CoreDecember 5, 2025
K253513premier dental productsMultiMatch Flow Chameleon AntiMicrobial CompositeNovember 7, 2025
K253236graphenano dental s.lG-BLOCKSeptember 29, 2025
K253053hangzhou shining3d dental technology coDura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)September 23, 2025
K251946gc americaG aenial Universal Injectable IIAugust 29, 2025
K251283mediclus coOnce-Fil FlowJune 6, 2025
K250317spident coEsFlow PLUSMay 30, 2025
K251578shofu dental corporationBEAUTIFIL IIMay 27, 2025