FDA device listing
Access S4500KL,Rotamax S6500KL,TDC 4500,TDC 6500
FDA device listing 1175593123 · Sable Industries, Inc.
Key facts
| Proprietary names | Access S4500KL,Rotamax S6500KL,TDC 4500,TDC 6500 |
|---|---|
| Owner/operator | Sable Industries, Inc. |
| Owner/operator number | 10024322 |
| Product codes | EFB |
| Device names | EFB - Handpiece, Air-Powered, Dental |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4200 |
| Review panels | Dental |
| Registered establishments | SABLE INDUSTRIES, INC. |
| Establishment registrations | 3002105090 |
| FEI numbers | 3002105090 |
| 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