Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)— 510(k) K260152

Name: FDA 510(k) clearance K260152
Creator: U.S. Food and Drug Administration
Published: 2026-04-23

Substantially Equivalent

Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.

FDA 510(k) clearance K260152 for Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT), Substantially Equivalent on 2026-04-23. Applicant: Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.. Device class: 2.

Summary

Mmtech Projetos Tecnologicos Importacao E Exportacao's Smart Print Bio Vitality is filed under product code EBF (Material, Tooth Shade, Resin). The name lists eight designations: A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, and B1-HT.

Class II, 21 CFR 872.3690. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Mmtech filed from São Carlos, Brazil. The decision came 93 calendar days after FDA received it (January 20 to April 23, 2026).

Clearance details

Applicant: Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.
Product code: Product code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2026-01-20
Decision date: 2026-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: São Carlos, BR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.