510(k) K260152
K260152 is an FDA 510(k) premarket notification submitted by Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. for the device "Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)". The FDA issued a decision of Substantially Equivalent on April 23, 2026. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690.
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