ACTEON
SATELEC · Model KIT LC EXTRACTION PTZ 2 · UDI-DI 03609820875460
DZI
Prescription
1
510(k) clearances
1,053
Adverse events
20
Recalls
80
Facilities
Description
For delicate extractions with less post-operative trauma. This kit of instruments, adapted to the anatomical context, is intended for clinical acts such as extraction of wisdom teeth, fractured roots, impacted teeth and root section. The tip gently slips between the root and "gently". Micro-ultrasonic oscillations cause detachment of the ligament without damaging the surrounding soft tissue.
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.