Quốc gia: Belarus
Ngôn ngữ: Tiếng Nga
Nguồn: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
MegaGen Implant Co., Ltd., РЕСПУБЛИКА КОРЕЯ
изделия медицинского назначения
MegaGen Implant Co.
2023-10-12
Surgical Instrument www.imegagen.com MegaGen Implant Co., Ltd 45, Sechen-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu 42921, Republic of Korea Tel. 82-53-222-2828 / Fax. 82-53-289-3420 Europe representative : MDSS GmbH Schiffgraben 41 30175 Hannover, Germany ● CE conformity marking ● Catalogue number ● Batch code ● Date of manufacture ● Serial number ● Non-sterile ● Temperature limitation ● Caution, consult accompanying documents ● Do not use if package is damaged ● Manufacturer ● Consult instructions for use ● Authorised representative in the european community Rx Only ● Caution: Federal law(USA) restricts this device to sale by or on the order of a licensed dentist IFU-II-R10/ 20-08-28 English 1. Product Summary To recover a patient’s masticatory function, it is necessary to have a dental implant which is implanted into a patient’s alveolar bone as a root of a tooth and abutment which is protruded through the gum in the oral cavity. These products include various Instruments to support implant surgery. 2. Intended Use These products are surgical instruments designed for the surgical placement of dental implants or prosthesis. It typically contain various dental drills, drill extensions, depth gauges, wrenches, drivers, osteotomes, path finders, and direction indicators designed in various types and sizes for use. ※ Surgical insertion instruments for temporary use(like Drill etc.) → All surgically invasive devices intended for transient use Surgically invasive devices that perform for creating hard tissue/ soft tissue shapes suitable for implant surgery, like to drilling holes on the bone cutting tissue. Product lines are as follows: - Lance drill - Tissue Punch - Marking Drill - Shaping Drill - Stopper Drill etc. ※ The Instruments that is not inserted surgically(like Connector, Driver etc.) → only to assist in the procedure Surgical non-invasive devices that perform to help for implant surgery and don't modify hard tissue/ soft tissue. Product lines are as follows: - Handpiece C Đọc toàn bộ tài liệu