FDA device listing
A59-0042,A59-0044,Vivid Total Bond SE
FDA device listing 1802243597 · ADVANCED HEALTHCARE LTD.
Key facts
| Proprietary names | A59-0042,A59-0044,Vivid Total Bond SE |
|---|---|
| Owner/operator | ADVANCED HEALTHCARE LTD. |
| Owner/operator number | 9005225 |
| Product codes | KLE |
| Device names | KLE - Agent, Tooth Bonding, Resin |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3200 |
| Review panels | Dental |
| Registered establishments | ADVANCED HEALTHCARE LTD. |
| Establishment registrations | 8044038 |
| FEI numbers | 3001027751 |
| Establishment operations | Contract Manufacturer |
| 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