Is this your brand? Sign in to claim ownership.
Sign in to claim this brandIVOCLAR VIVADENT AKTIENGESELLSCHAFT
US
Last updated May 23, 2026
What IVOCLAR VIVADENT AKTIENGESELLSCHAFT makes
The company manufactures resin-based artificial teeth for dental prosthetics, including preformed and custom-fit options for crowns, bridges, and veneers. It also produces ceramic and combination-material fabrication systems for dental appliances, as well as permanent dental implant suprastructures. Dental composite resins and temporary crown/bridge resins are part of its portfolio, alongside bonding agents designed for dentine adhesion.
These products are classified under FDA regulations as Class I and Class II devices, with most entries listed in the FDA’s Unique Device Identifier (UDI) database. The company’s portfolio is regulated under US medical device standards, ensuring compliance with applicable classification and reporting requirements.
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 Ivoclar Vivadent manufacture?
Ivoclar Vivadent manufactures a range of dental devices primarily focused on restorative and prosthetic solutions. Their portfolio includes resin-based artificial teeth for crowns, bridges, and veneers, as well as ceramic and combination-material systems for dental appliance fabrication. They also produce dental composite resins, temporary crown/bridge resins, and dentine bonding agents. These products are designed to support dental prosthetics, implants, and restorative procedures.
Where is Ivoclar Vivadent based, and how does this affect their regulatory compliance?
Ivoclar Vivadent is based in the US, which means their devices are subject to FDA regulations. Since their products fall under dental categories like artificial teeth, composite resins, and bonding agents, they are classified as either Class I or Class II devices under FDA guidelines. This classification determines the regulatory pathway, including reporting requirements and compliance standards, ensuring their devices meet US medical device safety and performance criteria.
Which regulatory registries list Ivoclar Vivadent’s devices?
Ivoclar Vivadent’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices in the US, ensuring transparency in regulatory reporting and compliance. Listing in this database is common for Class I and Class II devices, as it supports traceability and adherence to FDA requirements for dental restorative and prosthetic products.
How are Ivoclar Vivadent’s devices classified under FDA regulations?
Ivoclar Vivadent’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. For example, resin-based artificial teeth and bonding agents are typically Class II due to their direct interaction with patients’ oral tissues, requiring additional validation to meet regulatory standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 448015938
Catalogue (19974)
Page 10 of 400| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| IPS d.SIGN | 560532 | FDA UDI | Class II | Unknown |
| IPS InLine | 593201 | EUDAMEDFDA UDI | Class II | Active |
| IPS e.max Press | 605285 | FDA UDI | Class II | Active |
| OptraGloss | 684548AN | EUDAMEDFDA UDI | Class I | Active |
| Resin Teeth S PE S DCL | 683669 | FDA UDI | Class II | Active |
| Resin Teeth DCL PE | 504537 | FDA UDI | Class II | Unknown |
| Resin Teeth DCL PE | 611822 | FDA UDI | Class II | Unknown |
| Resin Teeth DCL PE | 504821 | FDA UDI | Class II | Unknown |
| Resin Teeth DCL PE | 540380 | FDA UDI | Class II | Unknown |
| Resin Teeth DCL PE | 536006 | FDA UDI | Class II | Unknown |
| Resin Teeth S PE S DCL | 656963 | FDA UDI | Class II | Unknown |
| Resin Teeth / DCL / PE | 604924 | EUDAMEDFDA UDI | Class II | Active |
| SR Phonares II | 645160 | EUDAMEDFDA UDI | Class II | Active |
| Resin Teeth / DCL / PE | 592651 | EUDAMEDFDA UDI | Class II | Active |
| Telio Lab | 632462AN | FDA UDI | Class II | Unknown |
| SR Nexco | 640500 | FDA UDI | Class II | Active |
| Resin Teeth / DCL / PE | 592614 | EUDAMEDFDA UDI | Class II | Active |
| Resin Teeth S PE / S DCL | 656898 | FDA UDI | Class II | Active |
| Resin Teeth S PE / S DCL | 656571 | FDA UDI | Class II | Active |
| Ivostar Gnathostar | 517113 | FDA UDI | Class II | Unknown |
| Resin Teeth DCL PE | 611721 | FDA UDI | Class II | Unknown |
| IPS e.max ZirCAD | 686891 | FDA UDI | Class II | Active |
| Ivostar Gnathostar | 577679 | FDA UDI | Class II | Active |
| Resin Teeth DCL PE | 540429 | FDA UDI | Class II | Active |
| SR Phonares II | 645019 | EUDAMEDFDA UDI | Class II | Active |
| SR Phonares II | 644824 | EUDAMEDFDA UDI | Class II | Active |
| SR Phonares II | 645016 | FDA UDI | Class II | Active |
| IPS e.max ZirCAD | 697484 | FDA UDI | Class II | Active |
| IPS e.max ZirCAD | 686873 | FDA UDI | Class II | Active |
| Ivostar Gnathostar | 577759 | FDA UDI | Class II | Active |
| Ivostar Gnathostar | 577678 | FDA UDI | Class II | Active |
| Ivostar Gnathostar | 577489 | FDA UDI | Class II | Active |
| Resin Teeth DCL PE | 749594 | FDA UDI | Class II | Active |
| Resin Teeth S PE S DCL | 683778 | FDA UDI | Class II | Active |
| Ivostar Gnathostar | 577587 | FDA UDI | Class II | Active |
| SR Phonares II | 645158 | EUDAMEDFDA UDI | Class II | Active |
| Resin Teeth S PE / S DCL | 656580 | FDA UDI | Class II | Active |
| IPS Ivocolor | 667649EN | EUDAMEDFDA UDI | Class II | Active |
| IPS Empress CAD | 602528 | FDA UDI | Class II | Active |
| Resin Teeth S DCL | 693694 | FDA UDI | Class II | Active |
| Resin Teeth / DCL / PE | 540566 | FDA UDI | Class II | Active |
| Resin Teeth / DCL / PE | 604896 | EUDAMEDFDA UDI | Class II | Active |
| SR Phonares II | 644937 | EUDAMEDFDA UDI | Class II | Active |
| IPS e.max Press | 626310 | FDA UDI | Class II | Active |
| Resin Teeth DCL PE | 612184 | FDA UDI | Class II | Unknown |
| Resin Teeth S DCL | 683883 | FDA UDI | Class II | Active |
| Resin Teeth DCL PE | 543240 | FDA UDI | Class II | Unknown |
| Resin Teeth S PE S DCL | 657369 | FDA UDI | Class II | Active |
| SR Phonares II | 644868 | FDA UDI | Class II | Active |
| Resin Teeth DCL PE | 749176 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.