Home › STERNGOLD DENTAL LLC › RP Countersink, 4.1mm Stainless Steel

RP Countersink, 4.1mm Stainless Steel

STERNGOLD DENTAL LLC · Model 905019 · UDI-DI 00841549114427

DZI Prescription

510(k) clearances

1,060

Adverse events

Recalls

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.RP Countersink is used for preparation of the bony receptor site involves the sequential use of drills and drilling components. Sterngold-ImplaMed® offers three drilling configurations; Externally Cooled Twist DrillsInternally Cooled Spade Drills, and Internally Cooled "Three Spade" Drills. All three styles are precision machined from high strength stainless steel and feature convenient depth markings and standard latch-type connectors.

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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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.