FDA device listing
Estelite Sigma Introductory Kit,One-Up Bond F Plus,Tokuyama One-Up Bond F
FDA device listing 1331552021 · TOKUYAMA DENTAL CORPORATION
Key facts
| Proprietary names | Estelite Sigma Introductory Kit,One-Up Bond F Plus,Tokuyama One-Up Bond F |
|---|---|
| Owner/operator | TOKUYAMA DENTAL CORPORATION |
| Owner/operator number | 9000502 |
| Premarket submissions | K993917 |
| 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 | TOKUYAMA DENTAL CORPORATION Kashima Factory |
| Establishment registrations | 3003621174 |
| FEI numbers | 3003621174 |
| Establishment operations | 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