510(k) K260152

Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) by Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2026
Date Received
January 20, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type