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Stern IC Starter Drill

STERNGOLD DENTAL LLC · Model 905703 · UDI-DI 00841549115103

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

Description

A metal device used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. There are depth marks along the length of some drills corresponding to the different size implant bodies. These marks are laser etched. Some drills are marked with the diameter in millimeters on the shank. Intended to be used to generate the bore into the bone into which an implant body or attachment is installed into.

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.