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Sign in to claim this brandVOCO GmbH
Germany·DE-MF-000008601
Last updated September 17, 2026
What VOCO GmbH makes
VOCO GmbH manufactures dental materials including composite resins for restorations, temporary crowns and bridges, bonding agents for dentine, silicone impression materials, desensitizing coatings, glass ionomer cements, and tooth-whitening products. Their portfolio also includes dentifrices and specialized mixing nozzles for dental applications.
The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, Class IIa, and Unclassified (U), with listings in the EUDAMED database and the FDA’s UDI system. VOCO GmbH is based in Germany.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does VOCO GmbH primarily manufacture?
VOCO GmbH specializes in dental materials, including composite resins for fillings and restorations, temporary crowns and bridges, bonding agents for tooth preparation, silicone impression materials for molds, desensitizing coatings for teeth, glass ionomer cements for restorations, and tooth-whitening products. Their portfolio also covers dentifrices (toothpastes) and specialized mixing nozzles for dental applications. These products are designed to support restorative, preventive, and cosmetic dental procedures.
Where is VOCO GmbH based, and how does this affect its regulatory compliance?
VOCO GmbH is based in Germany, which means its devices must comply with the European Union’s Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) depending on classification. Since the company’s devices are listed in the EUDAMED database, this indicates they are registered under EU regulatory requirements. The FDA’s UDI system listing further suggests their devices are also marketed in the U.S., where they must adhere to FDA regulations.
Which regulatory registries list VOCO GmbH’s devices, and why is this important?
VOCO GmbH’s devices are listed in EUDAMED, the European Union’s medical device registry, and the FDA’s UDI system, which tracks devices marketed in the U.S. Inclusion in these registries demonstrates compliance with respective regulatory bodies: EUDAMED confirms registration under EU MDR, while FDA UDI ensures traceability and transparency for U.S. market access. These listings help healthcare providers, regulators, and authorities verify the legitimacy and classification of the devices.
How are VOCO GmbH’s dental devices classified under EU regulations?
VOCO GmbH’s devices fall under Class I, Class II, Class IIa, and Unclassified (U) categories in the EU Medical Device Regulations. Classification depends on factors like risk level, intended use, and interaction with the body—for example, low-risk items like some dental coatings may qualify as Class I, while more complex restorative materials (e.g., composites or bonding agents) could be Class II or IIa due to their functional role in dental procedures. The classification determines regulatory requirements, such as clinical evaluations or conformity assessments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 1-3, Anton-Flettner-Str., Cuxhaven, Germany
- Website
- www.voco.de
- —
- —
- [email protected]
- Phone
- 999-999-9999
- PRRC Contact
- Andreas Lawerenz
- EUDAMED SRN
- DE-MF-000008601
- FDA FEI Number
- 3002718942
- DUNS Number
- 316699578
Catalogue (685)
Page 12 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Meron Application Capsules | K130421 | FDA 510(k) | Class II | Active |
| Ionofil Color Ac | K033068 | FDA 510(k) | Class II | Active |
| Rebilda Sc | K014111 | FDA 510(k) | Class II | Active |
| Ufi Gel hard C | K143486 | FDA 510(k) | Class II | Active |
| Cimara | K110589 | EUDAMEDFDA 510(k) | Class II | Active |
| Registrado Scan | K171815 | FDA 510(k) | Class II | Active |
| Chameleon Light/Chemical Cure Glass Ionomer | K930455 | FDA 510(k) | Class II | Active |
| Bifix Hybrid Abutment Cement | K220640 | EUDAMEDFDA 510(k) | Class II | Active |
| Ionofil Plus Ac | K042669 | EUDAMEDFDA 510(k) | Class II | Active |
| Grandtec | K102347 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Grandio Flow Try-In | K062343 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Tooth Bonding Agent | K920365 | FDA 510(k) | Class II | Active |
| BrackFix | K183147 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Ionofil/Lonofil Molar | K915619 | FDA 510(k) | Class II | Active |
| Grandio Core Dual Cure | K112447 | FDA 510(k) | Class II | Active |
| Aqua Ionofil | K922853 | FDA 510(k) | Class II | Active |
| Ionobond | K912497 | FDA 510(k) | Class II | Active |
| Futurabond Dc/Single Dose | K070723 | FDA 510(k) | Class II | Active |
| Celalux 3 | K153018 | FDA 510(k) | Class II | Active |
| Futurabond M/Futurabond M Single Dose | K082753 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Remin Pro | K101104 | FDA 510(k) | Class I | Active |
| Admira Seal | K021842 | FDA 510(k) | Class II | Active |
| GrandioSO x-tra | K181312 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| N-Hybride-Composite Lc | K113563 | FDA 510(k) | Class II | Active |
| Polibond | K924181 | FDA 510(k) | Class II | Active |
| Bifix Dental Cement | K926458 | FDA 510(k) | Class II | Active |
| Applicator AC 2 | 2334 | EUDAMEDFDA UDI | Class I | Active |
| Ceramic Bond | 1106 | EUDAMEDFDA UDI | Class IIa | Active |
| Arabesk | 1339 | EUDAMED | Class IIa | Active |
| Provicol QM Plus | 1098 | EUDAMEDFDA UDI | Class IIa | Active |
| GrandioSO Light Flow | 2585 | EUDAMEDFDA UDI | Class IIa | Active |
| Bifix Temp | 1055 | EUDAMEDFDA UDI | Class IIa | Active |
| Calcimol LC | 1047 | EUDAMEDFDA UDI | Class IIa | Active |
| Ionolux | 1990 | EUDAMEDFDA UDI | Class IIa | Active |
| Solobond M | 1225 | EUDAMED | Class IIa | Active |
| Polofil NHT Flow | 1113 | EUDAMED | Class IIa | Active |
| Dispenser | 2259 | EUDAMEDFDA UDI | Class I | Active |
| Futurabond U | 1576 | EUDAMEDFDA UDI | Class IIa | Active |
| Meron | 1086 | EUDAMEDFDA UDI | Class IIa | Active |
| Endo Tim | 2246 | EUDAMED | Class I | Active |
| Amaris | 1933 | EUDAMEDFDA UDI | Class IIa | Active |
| V-Print splint 2.0 | 6124 | EUDAMED | Class IIa | Active |
| Pele Tim | 2250 | EUDAMEDFDA UDI | Class I | Active |
| Provicol C | 1076 | EUDAMEDFDA UDI | Class IIa | Active |
| Sticky Tim | 2248 | EUDAMEDFDA UDI | Class I | Active |
| Fissurit F | 1180 | EUDAMED | Class IIa | Active |
| Mischkanülen | 2192 | EUDAMEDFDA UDI | Class I | Active |
| Alfacomp LC | 1058 | EUDAMED | Class IIa | Active |
| V-Print SG | 6043 | EUDAMEDFDA UDI | Class IIa | Active |
| Fissurit FX | 1181 | EUDAMED | Class IIa | Active |
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