Grandio disc multicolor— 510(k) K261357
Substantially EquivalentVoco GmbH
FDA 510(k) clearance K261357 for Grandio disc multicolor, Substantially Equivalent on 2026-04-27. Applicant: Voco GmbH. Device class: 2.
Summary
Voco GmbH's Grandio disc multicolor is filed under product code EBF (Material, Tooth Shade, Resin). The record doesn't describe the material beyond its name and that code name.
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).
Voco filed from Cuxhaven, Germany. The decision came 3 calendar days after FDA received it (April 24 to April 27, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- Voco GmbH
- Product code
- Product code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cuxhaven, DE
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