ACTEON
SATELEC · Model KIT INSERT BS PZT II · UDI-DI 03609820875095
DZI
Prescription
1
510(k) clearances
1,060
Adverse events
20
Recalls
80
Facilities
Description
For less traumatic bone surgery, Comprising six ultrasonic tips (three saws and three scalpels) adapted to the different cases that arise in the intra-oral environment, the BS Kit is used for clinical treatments such as: - bone harvesting, - osteoplasty, - crest expansion, - preparation of the implant site, - accessing the lower alveolar nerve.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
| 2019-03-14 | Nobel Biocare Usa Llc | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.