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ACTEON

SATELEC · Model KIT SL SINUS LIFT · UDI-DI 03609820873190

DZI Prescription
1
510(k) clearances
1,060
Adverse events
20
Recalls
80
Facilities

Description

The Sinus Lift Kit offers the practitioner a straightforward and safe answer for performing sinus elevation. The diamond-coated Sinus Lift tips for window cutting and the three spatula tips for membrane detachment are cooled by the sterile spray (thus avoiding tissue damage from exposure to high temperatures)

Recalls

DateFirmReason
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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
2019-03-14Nobel Biocare Usa LlcDue 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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Data 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.