FDA device listing
Helioseal F Plus
FDA device listing 1610241979 · IVOCLAR VIVADENT
Key facts
| Proprietary names | Helioseal F Plus |
|---|---|
| Owner/operator | IVOCLAR VIVADENT |
| Owner/operator number | 8010208 |
| Premarket submissions | K190339 |
| Product codes | EBC |
| Device names | EBC - Sealant, Pit And Fissure, And Conditioner |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3765 |
| Review panels | Dental |
| Registered establishments | IVOCLAR VIVADENT AG, Ivoclar Vivadent GmbH, IVOCLAR VIVADENT, INC., Ivoclar Vivadent Manufacturing, Inc |
| Establishment registrations | 2244842, 9612352, 3004966444, 3009496224 |
| FEI numbers | 2244842, 3002808636, 3004966444, 3009496224 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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