Sample Description for 510K Below: Need experienced 510K writer.
Trade Name: TADplant
Common Name: Temporary Anchorage Device and Abutment
Classification Name(s): Implant, Endosseous, Orthodontic, Dental
Classification Number: ? ? ? ? ? ? ? ?
The Temporary Anchorage Implant Screws known as the TAD Implants or TADplants are available in five lengths, 4mm, 6mm, 8mm, 10mm and 12mm. The external hex head top of the TADplant screw allows insertion and/or easy removal by either a manual screwdriver type instrument or by a driver instrument used with an implant motor. The TADplant screw is a two-piece device with abutments available in 3mm, 6mm and 12mm lengths. TADplant screws with abutments and provisional crowns are intended for immediate or delayed loading and are machine polished to prevent complete or enhanced osseointegration. TADplant screws are made from the same material, 100% biocompatible titanium, Ti 6Al-4V ELI, as the most...