FDA device listing
Barrier Sleeves,Bluephase G2 Sleeves,Bluephase G4 Sleeves,Bluephase Style Sleeves,VivaPen Sleeves
FDA device listing 1787395828 · IVOCLAR VIVADENT
Key facts
| Proprietary names | Barrier Sleeves,Bluephase G2 Sleeves,Bluephase G4 Sleeves,Bluephase Style Sleeves,VivaPen Sleeves |
|---|---|
| Owner/operator | IVOCLAR VIVADENT |
| Owner/operator number | 8010208 |
| Premarket submissions | K191448 |
| Product codes | PEM |
| Device names | PEM - Dental Barriers And Sleeves |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4370 |
| Review panels | General & Plastic Surgery |
| Registered establishments | IVOCLAR VIVADENT AG, Ivoclar Vivadent GmbH, IVOCLAR VIVADENT, INC. |
| Establishment registrations | 9612352, 3004966444, 3009496224 |
| FEI numbers | 3002808636, 3004966444, 3009496224 |
| Establishment operations | Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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