Voco Gmbh
ANTON-FLETTNER-STRASSE 1-3, CUXHAVEN Lower Saxony, DE
Registered product codes
41 product codes
Recent MDR events
32 on file
- PROVICOLMay 29, 2026Injury8010908-2026-00003
- PROFLUORID L SDMay 21, 2026Injury8010908-2026-00002
- VOCO PROFLUORID VARNISH MELONMay 7, 2026Injury8010908-2026-00001
- VOCO PROFLUORID VARNISHDec 4, 2024Injury8010908-2024-00001
- VOCO CLIPOct 6, 2023Injury8010908-2023-00005
- VOCO PROFLUORID VARNISHMay 5, 2023Injury8010908-2023-00004
- FUTURABOND U SINGLEDOSE 200Apr 20, 2023Injury8010908-2023-00003
- VOCO PROFLUORID VARNISHMar 21, 2023Injury8010908-2023-00002
- VOCO PROFLUORID VARNISHFeb 23, 2023Injury8010908-2023-00001
- VOCO PROFLUORID VARNISHOct 14, 2022Injury8010908-2022-00002
Recalls
4 on file
- Open, ClassifiedFeb 16, 2024
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.
View FDA record ↗ - Open, ClassifiedFeb 16, 2024
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.
View FDA record ↗ - TerminatedOct 1, 2019
The metal cannula are potentially too loose and may become loose when applying the filing material.
View FDA record ↗ - TerminatedJan 6, 2017
Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.
View FDA record ↗
Compliance history
Matched by FEI 3002718942.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
20 on file
Top refusal reasons
Compare to industry ↗- Division of Northeast Imports (DNEI)Jul 10, 2026
76EBF \ MATERIAL, TOOTH SHADE, RESIN
- Division of Northeast Imports (DNEI)Jul 10, 2026
76EJK \ LINER, CAVITY, CALCIUM HYDROXIDE
- Division of Northeast Imports (DNEI)Jul 10, 2026
76EBF \ MATERIAL, TOOTH SHADE, RESIN
- Division of Northeast Imports (DNEI)Jul 10, 2026
76EJK \ LINER, CAVITY, CALCIUM HYDROXIDE
- Division of Northeast Imports (DNEI)Jul 10, 2026
76EBG \ CROWN AND BRIDGE, TEMPORARY, RESIN
- Division of Northeast Imports (DNEI)Jul 10, 2026
76LBH \ VARNISH, CAVITY
- Division of Northeast Imports (DNEI)Jul 10, 2026
76EJK \ LINER, CAVITY, CALCIUM HYDROXIDE
- Division of Northeast Imports (DNEI)Jul 10, 2026
76KLE \ AGENT, TOOTH BONDING, RESIN
- Division of Northeast Imports (DNEI)Jul 10, 2026
76ELW \ MATERIAL, IMPRESSION
- Division of Southeast Imports (DSEI)Jul 1, 2026
76EBF \ MATERIAL, TOOTH SHADE, RESIN
- Division of Southeast Imports (DSEI)Jul 1, 2026
76EBF \ MATERIAL, TOOTH SHADE, RESIN
- Division of Southeast Imports (DSEI)Jul 1, 2026
76LBH \ VARNISH, CAVITY
- Division of Southeast Imports (DSEI)Jul 1, 2026
76LBH \ VARNISH, CAVITY
- Division of Southeast Imports (DSEI)Jul 1, 2026
76EBF \ MATERIAL, TOOTH SHADE, RESIN
- Division of Southeast Imports (DSEI)Jul 1, 2026
76MVL \ CORD, RETRACTION
- Division of Southeast Imports (DSEI)Jul 1, 2026
76EBC \ SEALANT, PIT AND FISSURE, AND CONDITIONER
- Division of Southeast Imports (DSEI)Jul 1, 2026
76EBG \ CROWN AND BRIDGE, TEMPORARY, RESIN
- Division of Southeast Imports (DSEI)Jul 1, 2026
76EBF \ MATERIAL, TOOTH SHADE, RESIN
- Division of Southeast Imports (DSEI)Jul 1, 2026
76EBF \ MATERIAL, TOOTH SHADE, RESIN
- Division of Southeast Imports (DSEI)Jul 1, 2026
76EBF \ MATERIAL, TOOTH SHADE, RESIN