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    Ортопедические элементы марки SIC для дентальной имплантации и зубного протезирования, в н

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    Регистрационный номер

    РЗН 2013/728

    Дата государственной регистрации

    11.06.2013

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    Наименование медицинского изделия

    Ортопедические элементы марки SIC для дентальной имплантации и зубного протезирования, в наборах и отдельных упаковкахI. Ортопедические элементы марки SIC для дентальной имплантации и зубного протезирования, в наборах:1. Набор Locator® Matrix Set, 5-part1.1. Локатор замещения Locator® Replacement Male, clear, 2.3 kg retention force ? 4 шт.1.2. Локатор замещения Locator® Replacement Male, pink, 1.4 kg retention force - 4 шт.1.3. Локатор замещения Locator® Replacement Male, blue, 0.7 kg retention force - 4 шт.1.4. Гнездо матрицы The Locator® matrix housing.1.5. Кольцо Polymerisation aid.II. Ортопедические элементы марки SIC для дентальной имплантации и зубного протезирования, в отдельных упаковках:1. Трансферы:1.1. SIC Transfer Caps: Ø 3.3 mm; Ø 4.2 mm - 5 шт.1.2. SIC Transfer Cap, reposition, for SICmax onepiece.1.3. SIC Transfer Abutment Ø 3.3 mm, reposition (incl. SIC Standard Fixation Screw and Transfer Cap Ø 3.3 mm).1.4. SIC Transfer Abutment Ø 3.3 mm, reposition, long (incl. SIC Standard Fixation Screw and Transfer Cap Ø 3.3 mm).1.5. SIC Transfer Abutment Ø 3.3 mm, Open Tray Technique (incl. SIC Fixation Screw 17.5 mm).1.6. SIC Transfer Abutment Ø 3.3 mm, Open Tray Technique (incl. SIC Fixation Screw 22.5 mm).1.7. SIC Transfer Abutment Ø 3.3 mm, Open Tray Technique, long (incl. SIC Fixation Screw 22.5 mm). 1.8. SIC Transfer Abutment Ø 3.3 mm, Open Tray Technique, long (incl. SIC Fixation Screw 27.5 mm).1.9. SIC Transfer Abutment Ø 4.2 mm, reposition (incl. SIC Standard Fixation Screw and Transfer Cap Ø 4.2 mm).1.10. SIC Transfer Abutment Ø 4.2 mm, reposition, long (incl. SIC Standard Fixation Screw and Transfer Cap Ø 4.2 mm).1.11. SIC Transfer Abutment "Safe on Four", reposition (incl. SIC Fixation Screw "Safe on Four" and Transfer Cap Ø 3.3 mm).1.12. SIC Transfer Abutment Ø 4.2 mm, Open Tray Technique (incl. SIC Fixation Screw 17.5 mm).1.13. SIC Transfer Abutment Ø 4.2 mm, Open Tray Technique (incl. SIC Fixation Screw 22.5 mm).1.14. SIC Transfer Abutment Ø 4.2 mm, Open Tray Technique, long (incl. SIC Fixation Screw 22.5 mm).1.15. SIC Transfer Abutment Ø 4.2 mm, Open Tray Technique, long (incl. SIC Fixation Screw 27.5 mm).2. Абатменты SIC Standard Abutment прямые с фиксирующим винтом:2.1. SIC Standard Abutment Ø 3.3 mm, anterior, straight: GH 1.0 mm; GH 2.0 mm; GH 3.0 mm; GH 5.0 mm (incl. SIC Standard Fixation Screw).2.2. SIC Standard Abutment Ø 3.3 mm, posterior, straight: GH 1.5 mm; GH 3.0 mm; GH 5.0 mm (incl. SIC Standard Fixation Screw).2.3. SIC Standard Abutment Ø 4.2 mm, anterior, straight: GH 1.0 mm; GH 2.0 mm; GH 3.0 mm; GH 5.0 mm; GH 7.0 mm (incl. SIC Standard Fixation Screw).2.4. SIC Standard Abutment Ø 4.2 mm, posterior, straight: GH 1.5 mm; GH 3.0 mm; GH 5.0 mm; GH 7.0 mm (incl. SIC Standard Fixation Screw).2.5. SIC Standard Abutment, straight, for cementation, for SICmax onepiece.2.6. SIC Standard Abutment CAD/CAM: Ø 3.3 mm; Ø 4.2 mm, straight, reamable (incl. SIC Standard Fixation Screw)3. Абатменты SIC Standard Abutment угловые с фиксирующим винтом:3.1. SIC Standard Abutment Ø 3.3 mm, anterior, 15° angle: GH 1.0 mm; GH 3.0 mm; GH 5.0 mm (incl. SIC Standard Fixation Screw).3.2. SIC Standard Abutment Ø 3.3 mm, posterior, 15° angle: GH 1.5 mm; GH 3.0 mm; GH 5.0 mm (incl. SIC Standard Fixation Screw).3.3. SIC Standard Abutment Ø 3.3 mm, 16° angle, GH 1.5 mm, for "Safe on Four" (incl. SIC Fixation Screw, short).3.4. SIC Standard Abutment Ø 3.3 mm, 30° angle, GH 1.5 mm, for "Safe on Four" (incl. SIC Fixation Screw, short).3.5. SIC Standard Abutment Ø 4.2 mm, anterior, 15° angle: GH 1.0 mm; GH 3.0 mm; GH 5.0 mm; GH 7.0 mm (incl. SIC Standard Fixation Screw).3.6. SIC Standard Abutment Ø 4.2 mm, posterior, 15° angle: GH 1.5 mm; GH 3.0 mm; GH 5.0 mm; GH 7.0 mm (incl. SIC Standard Fixation Screw).3.7. SIC Standard Abutment, 15° angle, for cementation, for SICmax onepiece.3.8. SIC Standard Abutment Ø 4.2 mm, 16° angle, GH 1.5 mm, for "Safe on Four" (incl. SIC Fixation Screw, short).3.9. SIC Standard Abutment Ø 4.2 mm, 30° angle, GH 1.5 mm, for "Safe on Four" (incl. SIC Fixation Screw, short).4. Абатменты SIC ?Flex Star? Universal Cast-to Abutment:4.1. SIC ?Flex Star? Universal Cast-to Abutment Ø 3.3 mm, for non-precious alloy (incl. SIC Standard Fixation Screw).4.2. SIC ?Flex Star? Universal Cast-to Abutment Ø 3.3 mm, high-fusing alloy (incl. SIC Standard Fixation Screw).4.3. SIC ?Flex Star? Universal Cast-to Abutment Ø 3.3 mm, for non-precious alloy, for bridgework (incl. SIC Standard Fixation Screw).4.4. SIC ?Flex Star? Universal Cast-to Abutment Ø 3.3 mm, high-fusing alloy, for bridgework (incl. SIC Standard Fixation Screw).4.5. SIC ?Flex Star? Universal Cast-to Abutment Ø 4.2 mm, for non-precious alloy (incl. SIC Standard Fixation Screw).4.6. SIC ?Flex Star? Universal Cast-to Abutment Ø 4.2 mm, high-fusing alloy (incl. SIC Standard Fixation Screw).4.7. SIC ?Flex Star? Universal Cast-to Abutment Ø 4.2 mm, for non-precious alloy, for bridgework (incl. SIC Standard Fixation Screw).4.8. SIC ?Flex Star? Universal Cast-to Abutment Ø 4.2 mm, high-fusing alloy, for bridgework (incl. SIC Standard Fixation Screw).5. Абатменты SIC ?White Star? Zirconium Oxide Abutments:5.1. SIC ?White Star? Zirconium Oxide Abutment Ø 3.3 mm, GH 1.5 mm, burn-onable (incl. SIC Standard Fixation Screw).5.2. SIC ?White Star? Zirconium Oxide Abutment Ø 3.3 mm, GH 3.0 mm, burn-onable (incl. SIC Standard Fixation Screw).5.3. SIC ?White Star? Zirconium Oxide Abutment Ø 4.2 mm, GH 1.5 mm, burn-onable (incl. SIC Standard Fixation Screw).5.4. SIC ?White Star? Zirconium Oxide Abutment Ø 4.2 mm, GH 3.0 mm, burn-onable (incl. SIC Standard Fixation Screw).6. Абатменты SIC Bar and Bridge Abutments:6.1. SIC Bar and Bridge Abutment Ø 3.3 mm: GH 1.5 mm; GH 3.0 mm.6.2. SIC Bar and Bridge Abutment Ø 4.2 mm: GH 1.5 mm; GH 3.0 mm.6.3. SIC Bar and Bridge Abutment "Safe on Four" Ø 3.3 mm, GH 1.5 mm (incl. SIC Fixation Post "Safe on Four" GH 1.5 mm).6.4. SIC Bar and Bridge Abutment "Safe on Four" Ø 3.3 mm, GH 3.0 mm (incl. SIC Fixation Post "Safe on Four" GH 3.0 mm).6.5. SIC Bar and Bridge Abutment "Safe on Four" Ø 4.2 mm, GH 1.5 mm (incl. SIC Fixation Post "Safe on Four" GH 1.5 mm).6.6. SIC Bar and Bridge Abutment "Safe on Four" Ø 4.2 mm, GH 3.0 mm (incl. SIC Fixation Post "Safe on Four" GH 3.0 mm).6.7. SIC Crown Base, Cast-to, for Bar and Bridge Abutments Ø 3.3/4.2 mm (for non-precious alloy).6.8. SIC Crown Base, Cast-to, for Bar and Bridge Abutments Ø 3.3/4.2 mm (high-fusing alloy).6.9. SIC Bar Coping for Bar and Bridge Abutments Ø 3.3/4.2 mm.7. Абатменты:7.1. SIC Conical Abutment for Provisional Implants.7.2. SIC Standard Abutment CAD/CAM Ø 3.3 mm, straight, GH 0.5 mm, for Brånemark System® RP (incl. SIC Screw Set for Brånemark System®).7.3. SIC Ball and Socket Abutment Ø 3.3 mm: GH 2.0 mm; GH 4.0 mm.7.4. SIC Telescopic Abutment Ø 3.3 mm, straight, reamable (incl. SIC Standard Fixation Screw).7.5. Steco Magnetic Abutment Ø 4.2 mm.7.6. SIC Ball and Socket Abutment Ø 4.2 mm: GH 2.0 mm; GH 4.0 mm.7.7. SIC Telescopic Abutment Ø 4.2 mm, straight, reamable (incl. SIC Standard Fixation Screw).7.8. SIC Wax-Up Abutment, straight, residue-free burn-out, for SICmax onepiece.8. Матрицы:8.1. Inner Assembly Matrix, blue (for model).8.2. Inner Matrix, gold, suitable for activation.8.3. Inner Matrix, yellow, light.8.4. Inner Matrix, green, standard.8.5. Inner Matrix, red, strong.9. Связывающая основа с фиксирующим винтом SIC Bonding Base:9.1 SIC Bonding Base CAD/CAM Ø 3.3 mm, straight, GH 0.3 mm (incl. SIC Standard Fixation Screw).9.2. SIC Bonding Base CAD/CAM Ø 3.3 mm, straight, GH 0.3 mm, for bridgework (incl. SIC Standard Fixation Screw).9.3. SIC Bonding Base CAD/CAM Ø 3.3 mm, 15° angle, GH 0.3 mm (incl. SIC Fixation Screw, short).9.4. SIC Standard Abutment CAD/CAM Ø 3.3 mm, straight, reamable (incl. SIC Standard Fixation Screw).9.5. SIC Bonding Base CAD/CAM Ø 4.2 mm, straight, GH 0.3 mm (incl. SIC Standard Fixation Screw).9.6. SIC Bonding Base CAD/CAM Ø 4.2 mm, straight, GH 0.3 mm, for bridgework (incl. SIC Standard Fixation Screw).9.7. SIC Bonding Base CAD/CAM Ø 4.2 mm, 15° angle, GH 0.3 mm (incl. SIC Fixation Screw, short).9.8. SIC Standard Abutment CAD/CAM Ø 4.2 mm, straight, reamable (incl. SIC Standard Fixation Screw).10. Восковая основа с фиксирующим винтом SIC Wax-Up Base:10.1. SIC Wax-Up Base CAD/CAM Ø 3.3 mm (incl. SIC Standard Fixation Screw).10.2. SIC Wax-Up Base CAD/CAM Ø 4.2 mm (incl. SIC Standard Fixation Screw).11. Аттачменты 11.1. SIC O-Ring Attachment for SICmax onepiece.11.2. SIC O-Ring Attachment for Provisional Implants.11.3. SIC Retention Attachment, for cementation, for SICmax onepiece.12. Винты:12.1. SIC Fixation Screw 17.5 mm, for Transfer Abutment, Open Tray Technique.12.2. SIC Fixation Screw 22.5 mm, for Transfer Abutment, Open Tray Technique.12.3. SIC Fixation Screw 27.5 mm, for Transfer Abutment, Open Tray Technique.12.4. SIC Standard Fixation Screw.12.5. SIC Horizontal Screw, length-adjustable (for transversal screw connection).12.6. SIC Fixation Screw for Crown Base: GH 1.5 mm; GH 3.0 mm.12.7. SIC Fixation Screw for Bar Coping: GH 1.5 mm; GH 3.0 mm.12.8. SIC Fixation Screw "Safe on Four".12.9. SIC Standard Fixation Screw red, for Ceramic Abutment CAD/CAM.12.10. SIC Fixation Screw, short.12.11. SIC Fixation Screw Brånemark System® RP, Interface.12.12. SIC Fixation Screw Brånemark System® for Transfer Abutment RP, Open Tray Technique.13. Винт-заглушка SIC «Augmentation Plus» Cover Screws: Ø 3.3 mm for SICace Screw Implants, Ø 3.4 mm and Ø 4.0 mm.13.1. SIC «Augmentation Plus» Cover Screw Ø 3.3 mm (incl. SIC «Augmentation Plus» Fixation Screw).Ø 4.2 mm for SICace Screw Implants, Ø 5.0 mm.13.2. SIC «Augmentation Plus» Cover Screw Ø 4.2 mm (incl. SIC «Augmentation Plus» Fixation Screw).14. Локаторы:14.1. Locator® Attachment Ø 3.3 mm: GH 0.0 mm; GH 1.0 mm; GH 2.0 mm; GH 3.0 mm; GH 4.0 mm; GH 5.0 mm, incl. Locator® Matrix Set 935717.14.2. Locator® Attachment Ø 4.2 mm: GH 0.0 mm; GH 1.0 mm; GH 2.0 mm; GH 3.0 mm; GH 4.0 mm; GH 5.0 mm, incl. Locator® Matrix Set 935717.14.3. Locator® Impression Post.14.4. Locator® Lab Implant14.5. Locator® Replacement Male, clear, 2.3 kg retention force ? 4 шт.14.6. Locator® Replacement Male, pink, 1.4 kg retention force ? 4 шт.14.7. Locator® Replacement Male, blue, 0.7 kg retention force ? 4 шт.14.8. Locator® Replacement Male, extended application, green, 1.8 kg retention force ? 4 шт.14.9. Locator® Replacement Male, extended application, orange, 0.9 kg retention force ? 4 шт.14.10. Locator® Replacement Male, extended application, red, 0.5 kg retention force ? 4 шт.14.11. Locator® Replacement Male, grey, no retention force ? 4 шт.15. Адаптеры: 15.1 SIC Scan Adapter for SICmax onepiece, for digital modelling of CAD/CAM Customized Milled Abutments.15.2 SIC Scan Adapter Ø 3.3 mm, for digital modelling of CAD/CAM Customized Milled Abutments (incl. SIC Standard Fixation Screw).15.3. SIC Scan Adapter Ø 4.2 mm, for digital modelling of CAD/CAM Customized Milled Abutments (incl. SIC Standard Fixation Screw).15.4. SIC Scan Adapter for "Safe on Four".16. Фиксирующие кольца:16.1. SIC Replacement O-Ring for SICmax onepiece, hard, green ? 10 шт.16.2. SIC Replacement O-Ring for SICmax onepiece, soft, red ? 10 шт.17. Лабораторные аналоги17.1. SIC Lab Implant for SICmax onepiece.17.2. SIC Lab Implant: Ø 3.3 mm; Ø 4.2 mm.17.3. SIC Lab Implantat "Safe on Four". 17.4. Steco Lab Implant for Magnetic Abutment.17.5. Lab Implant for Ball and Socket Attachments.18. Заготовки SIC Crown Base:18.1. SIC Crown Base "TITANIUM?, for "Safe on Four" (incl. SIC Fixation Screw "Safe on Four").18.2. SIC Crown Base "High fusing Alloy", for "Safe on Four" (incl. SIC Fixation Screw "Safe on Four").18.3. SIC Crown Base "For Non-Precious Alloy", for "Safe on Four" (incl. SIC Fixation Screw "Safe on Four").19. Формирователи десны SIC Gingiva Shaper:19.1. SIC Gingiva Shaper Ø 3.3 mm, cylindrical: GH 2.0 mm; GH 3.0 mm; GH 4.0 mm; GH 5.0 mm; GH 7.0 mm.19.2. SIC Gingiva Shaper Ø 4.2 mm, cylindrical: GH 2.0 mm; GH 3.0 mm; GH 4.0 mm; GH 5.0 mm; GH 7.0 mm.19.3. SIC Gingiva Shaper Ø 3.3 mm, concave, anterior: GH 1.0 mm; GH 2.0 mm; GH 3.0 mm; GH 4.0 mm; GH 5.0 mm.19.4. SIC Gingiva Shaper Ø 4.2 mm, concave, anterior: GH 1.0 mm; GH 2.0 mm; GH 3.0 mm; GH 4.0 mm; GH 5.0 mm; GH 7.0 mm.19.5. SIC Gingiva Shaper Ø 3.3 mm, concave, posterior: GH 1.5 mm; GH 3.0 mm; GH 4.0 mm; GH 5.0 mm19.6. SIC Gingiva Shaper Ø 4.2 mm, concave, posterior: GH 1.5 mm; GH 3.0 mm; GH 4.0 mm; GH 5.0 mm; GH 7.0 mm.19.7. SIC Gingiva Shaper for "Safe on Four", cylindrical.20. Колпачки:20.1. Retention Cap, universal.20.2. Spacer for Retention Cap, universal.21. Штифт:21.1. SIC Fixation Post "Safe on Four": GH 1.5 mm; GH 3.0 mm.22. Стандартная балка:22.1. SIC Standard Bar, round, Ø 2.0 mm, 50 mm, gold.23. Балочный замок: 23.1. SIC Bar Clip, 50 mm, gold.24. Сварной имплантат для абатмента балок и мостов: 24.1. SIC Soldering Implant Ø 3.3 mm, for Bar and Bridge Abutment. 24.2. SIC Soldering Implant Ø 4.2 mm, for Bar and Bridge Abutment.25. Магнит для протеза: 25.1. Steco Magnet for Prosthesis.26. Позиционирующая манжета для магнитного абатмента: 26.1. Steco Positioning Cuff for Magnetic Abutment.27. Установочное приспособление для магнитного абатмента:27.1. Steco Insertion Tool for Magnetic Abutment.28. Втулка для горизонтального винта: 28.1. SIC Sleeve for Horizontal Screw (high-fusing alloy).29. Приспособление для позиционирования: 30.1. SIC Positioning Aid 16° and 30° for "Safe on Four".30. Пластина: 31.1. Block-Out Aid (distance plate) ? 2 шт.31. Кольцо:32.1. Polymerisation Aid (PVC ring) - 10 шт.III. Производители:1. SIC invent AG, Birmannsgasse 3, CH - 4055 Basel, Switzerland2. CPM Präzisionsdrehtechnik GmbH, Im Rott 5-10, 69493 Hirschberg, Germany.3. ZEST ANCHORS, LLC, 2061 Wineridge Place, Escondido CA 92029, USA.4. ELOS MEDTECH PINOL A/S, Engvej 33, DK-3330 Gørløse, Denmark.5. SIMEDA S.A., Z.I. Eselborn-Lentzweiler, 18, Op der Sang, 9779 Eselborn, Luxembourg.

    Наименование организации – заявителя

    ООО "Свисс Имплант Компани"

    Место нахождения организации-заявителя

    125319, Россия, Московская область, г. Москва, ул. Красноармейская, д. 23, кв. 56

    Юридический адрес организации-заявителя

    125319, Россия, Московская область, г. Москва, ул. Красноармейская, д. 23, кв. 56

    Наименование организации-производителя или организации-изготовителя

    СИК инвент АГ

    Место нахождения организации-производителя или организации – изготовителя

    , Швейцария, Дальнее зарубежье, SIC invent AG, Birmannsgasse 3, CH - 4055 Basel, Switzerland

    Юридический адрес организации-производителя или организации – изготовителя

    , Швейцария, Дальнее зарубежье, SIC invent AG, Birmannsgasse 3, CH - 4055 Basel, Switzerland

    ОКП/ОКПД2

    94 3820

    Класс потенциального риска применения медицинского изделия

    2а

    Назначение медицинского изделия, установленное производителем

    Адрес места производства или изготовления медицинского изделия

    1. SIC invent AG, Birmannsgasse 3, CH - 4055 Basel, Switzerland.2. CPM Präzisionsdrehtechnik GmbH, Im Rott 5-10, 69493 Hirschberg, Germany.3. ZEST ANCHORS, LLC, 2061 Wineridge Place, Escondido CA 92029, USA.4. ELOS MEDTECH PINOL A/S, Engvej 33, DK-3330 Gørløse, Denmark.5. SIMEDA S.A., Z.I. Eselborn-Lentzweiler, 18, Op der Sang, 9779 Eselborn, Luxembourg.

    Контакты производителя медицинского изделия

    Контакты дистрибутора в России №1

    Контакты дистрибутора в России №2

    Контакты дистрибутора в России №3

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