GRANDIO— 510(k) K051867

Substantially Equivalent

Voco GmbH

FDA 510(k) clearance K051867 for GRANDIO, Substantially Equivalent on 2005-07-27. 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: 2005-07-11
Decision date: 2005-07-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Bend, OR, US

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
K251239 — GrandioSO Unlimited2025-05-21

Recalls naming K051867

K-number listed on FDA's recall record

Z-3016-2026 — Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145 2) 949-3595, Mfr Product Code 1841; Lots 2539075, 2539313, 2609789, 2539065 3) 949-3596, Mfr Product Code 1842; Lots 2536632, 2609174, 2610099 4) 949-3597, Mfr Product Code 1843; Lots 2535296, 2537418, 2607283 is a light-cured, nano-hybrid dental composite restorative material intended for direct restorative procedures.Class II·Ongoing·Henry Schein Inc.·20260709

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051867.

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