FDA device listing
Craniomaxillofacial Surgery Tips: SL3 -- BS6 XXL -- BS4 --SL2 -- SL1 -- BS2R XL -- BS2L XL -- BS1 XXL -- BS1L…
FDA device listing 1997241089 · SATELEC-ACTEON GROUP
Key facts
| Proprietary names | Craniomaxillofacial Surgery Tips: SL3 -- BS6 XXL -- BS4 --SL2 -- SL1 -- BS2R XL -- BS2L XL -- BS1 XXL -- BS1L -- BS1RD,PIEZOTOME M+ |
|---|---|
| Owner/operator | SATELEC-ACTEON GROUP |
| Owner/operator number | 9004992 |
| Premarket submissions | K163610 |
| Product codes | DZI, ERL, HBE, HWE, JDX |
| Device names | DZI - Drill, Bone, Powered, ERL - Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, HBE - Drills, Burrs, Trephines & Accessories (Simple, Powered), HWE - Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, JDX - Instrument, Surgical, Sonic And Accessory/Attachment |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 872.4120, 874.4250, 878.4820, 882.4310, 888.4580 |
| Review panels | Dental, Ear, Nose, & Throat, General & Plastic Surgery, Neurology, Orthopedic |
| Registered establishments | SATELEC-ACTEON GROUP |
| Establishment registrations | 8044015 |
| FEI numbers | 3004536551 |
| Establishment operations | Manufacturer |
| 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