Voco GmbH
CUXHAVEN Lower Saxony, DE
VOCO GMBH appears in FDA device records in CUXHAVEN Lower Saxony, DE. FDA records list 78 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 78FDA records hold 78 510(k) clearances for Voco GmbH between 2003 and 2026. The busiest year on record is 2011, with 8. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 3 |
| 2005 | 1 |
| 2006 | 7 |
| 2007 | 4 |
| 2008 | 3 |
| 2009 | 5 |
| 2010 | 7 |
| 2011 | 8 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 3 |
| 2015 | 4 |
| 2016 | 5 |
| 2017 | 3 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 5 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 3 |
| 2025 | 2 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252073 | VOCO Profluorid Varnish + BioMin | LBH | Substantially Equivalent | |
| K261357 | Grandio disc multicolor | EBF | Substantially Equivalent | |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-In | EMA | Substantially Equivalent | |
| K251390 | MTA vpt | KIF | Substantially Equivalent | |
| K251239 | GrandioSO Unlimited | EBF | Substantially Equivalent | |
| K231817 | AlignerFlow LC | DYH | Substantially Equivalent | |
| K231591 | V-Print c&b temp | POW | Substantially Equivalent | |
| K230877 | Admira Fusion 5 | EBF | Substantially Equivalent | |
| K220236 | V-Print dentbase | EBI | Substantially Equivalent | |
| K220640 | Bifix Hybrid Abutment Cement | EMA | Substantially Equivalent | |
| K220743 | CediTEC | EBI | Substantially Equivalent | |
| K213149 | VOCO Retraction Paste | MVL | Substantially Equivalent | |
| K201091 | V-Print splint | MQC | Substantially Equivalent | |
| K201090 | Structur CAD | EBG | Substantially Equivalent | |
| K201856 | Provicol QM Aesthetic | EMA | Substantially Equivalent | |
| K201307 | VisCalor | EBF | Substantially Equivalent | |
| K200294 | GrandioSO Light Flow | EBF | Substantially Equivalent | |
| K190453 | VisCalor bulk | EBF | Substantially Equivalent | |
| K183147 | BrackFix | DYH | Substantially Equivalent | |
| K181312 | GrandioSO x-tra | EBF | Substantially Equivalent | |
| K180386 | Meron Plus QM | EMA | Substantially Equivalent | |
| K171815 | Registrado Scan | EBF | Substantially Equivalent | |
| K171200 | Grandio blocs | EBF | Substantially Equivalent | |
| K170896 | Admira Fusion x-base | EBF | Substantially Equivalent | |
| K161630 | Provicol QM Plus | EMB | Substantially Equivalent | |
| K160774 | IonoStar Plus | EMA | Substantially Equivalent | |
| K153493 | Clip Flow | EBF | Substantially Equivalent | |
| K153177 | Admira Fusion Flow | EBF | Substantially Equivalent | |
| K153018 | CELALUX 3 | EBZ | Substantially Equivalent | |
| K151956 | Admira Fusion x-tra | EBF | Substantially Equivalent | |
| K150784 | Admira Fusion | EBF | Substantially Equivalent | |
| K143212 | Bifix Temp | EMA | Substantially Equivalent | |
| K143486 | Ufi Gel hard C | EBI | Substantially Equivalent | |
| K140993 | IONOSTAR MOLAR | EMA | Substantially Equivalent | |
| K141610 | FUTURABOND M+ | KLE | Substantially Equivalent | |
| K130485 | CONTROL SEAL | EBC | Substantially Equivalent | |
| K130421 | MERON APPLICATION CAPSULES | EMA | Substantially Equivalent | |
| K130486 | FUTURABOND UNIVERSAL | KLE | Substantially Equivalent | |
| K123773 | X-TRA BASE | EBF | Substantially Equivalent | |
| K120779 | STRUCTUR 3 | EBG | Substantially Equivalent | |
| K113563 | N-HYBRIDE-COMPOSITE LC | EBF | Substantially Equivalent | |
| K113444 | N-HYBRIDE-COMPOSITE LC FLOW | EBF | Substantially Equivalent | |
| K112447 | GRANDIO CORE DUAL CURE | EBF | Substantially Equivalent | |
| K112374 | X-TRA BASE | EBF | Substantially Equivalent | |
| K110589 | CIMARA | EBF | Substantially Equivalent | |
| K110440 | QUICK UP | EBI | Substantially Equivalent | |
| K110050 | FIT TEST C&B | ELW | Substantially Equivalent | |
| K103580 | GRANDIO SO FLOW | EBF | Substantially Equivalent | |
| K102612 | VOCO IONOFIL MOLAR AC QUICK | EMA | Substantially Equivalent | |
| K102354 | GRANDIO SO HEAVY FLOW | EBF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010908 | 3002718942 | VOCO GMBH | ANTON-FLETTNER-STRASSE 1-3, CUXHAVEN Lower Saxony D-27472 DE | 2026 | and 31 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- EBZActivator, Ultraviolet, For Polymerization
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- EFDAmalgamator, Dental, Ac-Powered
- EMACement, Dental
- EBDCoating, Filling Material, Resin
- QGOComposite Resin Warmer
- MVLCord, Retraction
- POWCrown And Bridge, Long-Term Temporary, Resin
- EBGCrown And Bridge, Temporary, Resin
- EHQCusp, Preformed
- PEMDental Barriers And Sleeves
- ELMDenture, Plastic, Teeth
- EHJDisk, Abrasive
- DZADrill, Dental, Intraoral
- FRLFiber, Medical, Absorbent
- EKSFile, Pulp Canal, Endodontic
- EJBHandle, Instrument, Dental
- EEGHeat Source For Bleaching Teeth
- DZNInstruments, Dental Hand
- EJKLiner, Cavity, Calcium Hydroxide
- DYTMaintainer, Space Preformed, Orthodontic
- ELWMaterial, Impression
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- MQCMouthguard, Prescription
- EEAPlate, Base, Shellac
- EHLPoint, Abrasive
- KMYPositioner, Tooth, Preformed
- ELRPost, Root Canal
- EBIResin, Denture, Relining, Repairing, Rebasing
- KIFResin, Root Canal Filling
- DYJRetainer, Screw Expansion, Orthodontic
- EBCSealant, Pit And Fissure, And Conditioner
- EIDSyringe, Restorative And Impression Material
- EHYTray, Impression, Preformed
- LBHVarnish, Cavity
- EFCWarmer, Anesthetic Tube
- EMBZinc Oxide Eugenol
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1143-2024 | Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement | Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible. | Class II | Open, Classified | |
| Z-1142-2024 | IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement | Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible. | Class II | Open, Classified | |
| 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.). | The metal cannula are potentially too loose and may become loose when applying the filing material. | Class II | Terminated | |
| Z-0955-2017 | VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restorative, core build-up or luting materials. It can be applied with phosphoric acid etching (selective enamel etching or total-etch) of the dental hard tissue as well as without (self-etch). A1] Adhesive for direct restorations of all classes of cavities using light-curing composite /compomer / Ormocer materials with a methacrylate base. [A2] Adhesive for core build-ups made of light-curing composite materials. [A3] Adhesive for indirect restorations with light-curing luting composites. [B] Intraoral repair of composite, compomer or Ormocer restorations, ceramic veneers and allceramic restorations without an additional primer. [C] Treatment of hypersensitive tooth necks. [D] Protective varnish for glass ionomer cement restorations. [E1] Sealing of cavities prior to amalgam restorations. [E2] Sealing of cavities and core preparations prior to the temporary luting of indirect restorations. In combination with Futurabond M+ DCA (Dual Cure Activator): [F1] Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups. | Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain