GRANDIO SO HEAVY FLOW— 510(k) K102354

Substantially Equivalent

Voco GmbH

FDA 510(k) clearance K102354 for GRANDIO SO HEAVY FLOW, Substantially Equivalent on 2010-11-08. 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: 2010-08-19
Decision date: 2010-11-08
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
K251239 — GrandioSO Unlimited2025-05-21

Recalls naming K102354

K-number listed on FDA's recall record

Z-0028-2020 — Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).Class II·Terminated·Voco GmbH·20190709

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102354.

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