FDA device listing
FDA Product Code EFB: Electronic fiber optic control board,FDA Product Code EFB: Premium Slow Speed 20K Air Motors w/…
FDA device listing 1375323092 · Sable Industries, Inc.
Key facts
| Proprietary names | FDA Product Code EFB: Electronic fiber optic control board,FDA Product Code EFB: Premium Slow Speed 20K Air Motors w/ Internal Air & Water,FDA Product Code EFB: Premium Slow Speed Straight Nosecones 1:1 Ball Bearing w/ Internal Air & Water,FDA Product Code EFB: Sable EX-203 Type 22K 4-Hole Air Motors,FDA Product Code EFB: Sable EX-6 Type 1:1 Straight Attachments,FDA Product Code EFB: Sable IS-205… |
|---|---|
| Owner/operator | Sable Industries, Inc. |
| Owner/operator number | 10024322 |
| Premarket submissions | K083101 |
| Product codes | EFB, EGS |
| Device names | EFB - Handpiece, Air-Powered, Dental, EGS - Handpiece, Contra- And Right-Angle Attachment, 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 | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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