Clearance Summary
Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) received FDA 510(k) clearance under submission number K260152, sponsored by Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2026-04-23.
- Submission: K260152
- Applicant / Sponsor: Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2026-04-23
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.