FDA device listing
ProArt CAD Try-In,SR-IVOLEN,SR-IVOLEN TRAY MATERIAL
FDA device listing 1196400213 · IVOCLAR VIVADENT
Key facts
| Proprietary names | ProArt CAD Try-In,SR-IVOLEN,SR-IVOLEN TRAY MATERIAL |
|---|---|
| Owner/operator | IVOCLAR VIVADENT |
| Owner/operator number | 8010208 |
| Product codes | EBH |
| Device names | EBH - Material, Impression Tray, Resin |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.3670 |
| Review panels | Dental |
| Registered establishments | CANDULOR, AG, Candulor Dental GmbH, IVOCLAR VIVADENT AG, Ivoclar Vivadent GmbH, IVOCLAR VIVADENT, INC., Ivoclar Vivadent Manufacturing GmbH |
| Establishment registrations | 9612352, 1000277456, 3003310824, 3004966444, 3009496224, 3011511773 |
| FEI numbers | 1000277456, 3002808636, 3003310824, 3004966444, 3009496224, 3011511773 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Manufacturer, Specification Developer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database