GrandioSO Unlimited— 510(k) K251239

Substantially Equivalent

Voco GmbH

FDA 510(k) clearance K251239 for GrandioSO Unlimited, Substantially Equivalent on 2025-05-21. Applicant: Voco GmbH. Device class: 2.

Clearance details

Applicant: Voco GmbH
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2025-04-22
Decision date: 2025-05-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Cuxhaven, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Voco GmbH

K252073 — VOCO Profluorid Varnish + BioMin2026-05-01
K261357 — Grandio disc multicolor2026-04-27
K252606 — Bifix Veneer LC, Bifix Veneer Try-In2026-03-20
K251390 — MTA vpt2025-07-03
K231817 — AlignerFlow LC2023-12-01

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