510(k) Report

FDA applicant

Voco GmbH

Cuxhaven, DE119 decisions1991–20266 recalls

FDA records 119 decisions for Voco GmbH (Cuxhaven, DE) from 1991 to 2026: 119 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EMA (Cement, Dental). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 157 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 6 of them its own earlier devices. 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Voco GmbH’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2007: 42008: 32009: 52010: 72011: 82012: 22013: 22014: 32015: 42016: 52017: 32018: 22019: 22020: 52021: 12022: 32023: 32025: 22026 (partial year): 3
2007high 8 (2011) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

2in 2026

2016: 12019: 12024: 22026 (partial year): 2
2007high 2 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Voco GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Voco GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin45decisions
  • EMACement, Dental26decisions
  • KLEAgent, Tooth Bonding, Resin10decisions
  • EBIResin, Denture, Relining, Repairing, Rebasing8decisions
  • EBGCrown And Bridge, Temporary, Resin5decisions
  • EBCSealant, Pit And Fissure, And Conditioner5decisions

Also: EJK (4), ELW (3), LBH (3), DYH (2), EBD (1), EBZ (1).

How long do its 510(k) reviews take?

Since 2016, its 24 510(k)s took a median of 111 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 157 days; 15 of its 24 were faster than that.

Whose devices does it build on?

Its devices cite 24 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 34 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K153493Clip FlowVoco GmbH · 20164cite it
  • K926418CLIPVoco GmbH · 19933cite it
  • K051867GrandioVoco GmbH · 20053cite it
  • K062345Ceramic BondVoco GmbH · 20062cite it
  • K062344Grandio SealVoco GmbH · 20062cite it
  • K231817AlignerFlow LCVoco GmbH · 20232cite it

What has FDA decided for it lately?

  • K252073VOCO Profluorid Varnish + BioMinVoco GmbH · 2026
  • K261357Grandio disc multicolorVoco GmbH · 2026
  • K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH · 2026
  • K251390MTA vptVoco GmbH · 2025
  • K251239GrandioSO UnlimitedVoco GmbH · 2025
  • K231817AlignerFlow LCVoco GmbH · 2023
  • K231591V-Print c&b tempVoco GmbH · 2023
  • K230877Admira Fusion 5Voco GmbH · 2023

All 119 as Voco GmbH →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K051867Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1)…Jul 9, 2026Class II
  • K040769Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr…Jul 9, 2026Class II
  • K090817Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122…Jan 25, 2024Class II
  • K160774IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f)…Jan 25, 2024Class II
  • K102354Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive…Jul 9, 2019Class II
  • K141610VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a…Nov 3, 2016Class II