FDA device listing
OptiBond eXTRa Universal
FDA device listing 1659474519 · SYBRON DENTAL SPECIALTIES, INC.
Key facts
| Proprietary names | OptiBond eXTRa Universal |
|---|---|
| Owner/operator | SYBRON DENTAL SPECIALTIES, INC. |
| Owner/operator number | 9029565 |
| Premarket submissions | K182162 |
| 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 | Kerr Corporation, Kerr Italia, S.r.l., SDS de Mexico S. de R.L. de C.V. |
| Establishment registrations | 2024312, 8020994, 9680845, 3032378317 |
| FEI numbers | 2024312, 1000231788, 3000368601, 3032378317 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract Manufacturer |
| 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