Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list VOCO GmbH with 119 510(k) clearances and 4 device recalls. The most recent is a 510(k) clearance dated May 1, 2026: VOCO Profluorid Varnish + BioMin.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 1, 2026 | VOCO Profluorid Varnish + BioMinK252073 · LBH | 510(k) clearances |
| Apr 27, 2026 | Grandio disc multicolorK261357 · EBF | 510(k) clearances |
| Mar 20, 2026 | Bifix Veneer LC, Bifix Veneer Try-InK252606 · EMA | 510(k) clearances |
| Jul 3, 2025 | MTA vptK251390 · KIF | 510(k) clearances |
| May 21, 2025 | GrandioSO UnlimitedK251239 · EBF | 510(k) clearances |
| Jan 25, 2024 | Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cementClass II · Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. | Device recalls |
| Jan 25, 2024 | IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cementClass II · Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. | Device recalls |
| Dec 1, 2023 | AlignerFlow LCK231817 · DYH | 510(k) clearances |
| Jul 31, 2023 | V-Print c&b tempK231591 · POW | 510(k) clearances |
| Jul 13, 2023 | Admira Fusion 5K230877 · EBF | 510(k) clearances |
| Jul 9, 2019 | Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities anClass II · The metal cannula are potentially too loose and may become loose when applying the filing material. | Device recalls |
| Nov 3, 2016 | VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restoratClass II · Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
