ACTEON
SATELEC · Model SL INTRALIFT KIT · UDI-DI 03609820873367
DZI
Prescription
1
510(k) clearances
1,060
Adverse events
20
Recalls
80
Facilities
Description
The hydrodynamic sinus lift technique by the crestal approach. The diamond-coated tips, of increasing diameters (from 1.35mm to 2.80mm), are designed to drill and widen gradually the access canal to the Schneider membrane. The sterile spray cools down the tips to avoid any rise in temperature, which could lead to tissue damage. The membrane elevation is achieved using the TKW5 by means of microcavitation.
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.