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    Ортопедические элементы марки Biomed для дентальной имплантации и зубного протезирования

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    ФСЗ 2012/12238

    Дата государственной регистрации

    14.06.2012

    Срок действия регистрационного удостоверения

    Наименование медицинского изделия

    Ортопедические элементы марки Biomed для дентальной имплантации и зубного протезирования (см. Приложение на 9 листах)I. Ортопедические элементы марки Biomed для дентальной имплантации и зубного протезирования:1. Адаптеры угловые: 1.1. GCS/GBC Angulations Adapter 15°, long, Ti6Al4V (BM1302).1.2. GCS/GBC Angulations Adapter 15°, short, Ti6Al4V (BM1303).1.3. GCS/GBC Angulations adapter 25°, long, Ti6Al4V (BM1304).1.4. GCS/GBC Angulations adapter 25°, short, Ti6Al4V (BM1305).1.5. GCS/GBC Angulation Adapter 15°, circonia (BM1306).1.6. GCS/GBC Angulation Adapter 25°, circonia (BM1307).1.7. GCS/GBC Burn-out angulations adapter 15°, Plastic (BM1308).2. Абатменты:2.1. Burn-out abutment for abutment analog, Plastic (BM1310).2.2. Anatomic Abutment D 1.5, TiGr2 (BM1410).2.3. Anatomic Abutment D 3 TiGr2 (BM1411).2.4. Anatomic Abutment D 4 TiGr2 (BM1412).2.5. Anatomic Abutment D 15 1.5, TiGr2 (BM1413).2.6. Anatomic Abutment D 25 1.5, TiGr2; (BM1414).2.7. Anatomic Abutment D 15 3, TiGr2 (BM1415).2.8. Anatomic Abutment D 25 3, TiGr2 (BM1416).2.9. Anatomic Abutment D 1.5, Zirkon (BM1417).2.10. Anatomic Abutment D 3, Zirkon (BM1418).2.11. Anatomic Abutment D 4, Zirkon (BM1419).2.12. Anatomic Abutment D 15 Degr. 1.5, Zirkon (BM1420).2.13. Anatomic Abutment D 25 Degr. 1.5 (BM1421).2.14. Anatomic Abutment D 15 Degr. 3, Zirkon (BM1422).2.15. Anatomic Abutment D 25 Degr. 1.5, Zirkon (BM1423). 2.16. GIH Abutment straight, Ti6Al4V (BM3030).2.17. GIH Abutment angled 15o, 1mmh, Ti6Al4V (BM3031).2.18. GIH Abutment angled 15o, 2mmh, Ti6Al4V (BM3032).2.19. GIH Abutment angled 15o, 3mmh, Ti6Al4V (BM3033).2.20. GIH Abutment angled 25o, 1mmh, Ti6Al4V (BM3034).2.21. GIH Abutment angled 25o, 2mmh, Ti6Al4V (BM3035).2.22. GIH Abutment angled 25o, 3mmh, Ti6Al4V (BM3036).2.23. GIH Srew-in Abutment for without hex, Ti6Al4V (BM3038).2.24. GIH Abutment narrow Ti6Al4V (BM3039).2.25. GIH straight lock Abutment, 2mmh, Ti6Al4V (BM3045).2.26. GIH straight lock Abutment, 4mmh, Ti6Al4V (BM3046).2.27. Multiunit Abumtment Hexacone 20 Degr. internally round, Ti6Al4V (BM3060).2.28. Castable abutment for screw on abutment, 10.5mmh, Plastic (BM3119).2.29. Reverse cone abutment for HC, 20 degr. incl. screw, Ti6Al4V (BM3062).2.30. Soldering abutment for GIH, CoCrMo (BM3063).2.31. Screw abutment, 0.5mmh, Ti6Al4V (BM3121).2.32. Screw abutment, 1.5mmh, Ti6Al4V (BM3122).2.33. Screw abutment, 2.5mmh, Ti6Al4V (BM3123).2.34. Plastic lock abutment, incl screw (Ti6Al4V) (BM3131).2.35. GIH Multiunit abutment ext. Hex, Ti6Al4V (BM3146).2.36. GIH Multiunit abutment, round, Ti6Al4V (BM3147).2.37. Castable abutment for Multiunit, Plastic (BM3149).2.38. Ball abutment for fittings 2.5mm, Ti6Al4V (BM3154).2.39. Ball abutment 2.5mm, 0.5mmh, Ti6Al4V (BM3155).2.40. Ball abutment 2.5mm, 2.0mmh, Ti6Al4V (BM3156).2.41. Ball abutment 2.5mm, 4.0mmh, Ti6Al4V (BM3157).2.42. TLA15 GIO, incl. Screw, Ti6Al4V (BM4040).2.43. TLA25 GIO, incl. Screw, Ti6Al4V (BM4041).2.44. TLA GIO, incl. Screw, Ti6Al4V (BM4042).2.45. Burn-out abutment for TOI, Plastic (BM5121).2.46. Metal Abutment GBC small, Ti6Al4V (BM6024).2.47. Metal Abutment TOI large, Ti6Al4V (BM6025).2.48. TLA2 15 GBL NC, Ti6Al4V (BM6030).2.49. TLA2 15 GBL RC, Ti6Al4V (BM6031).2.50. TAB GBL RC Abutment, Ti6Al4V (BM6032).2.51. Platform Offset Zirkon Okta Lock Abutment, 0.5 mmh (BM6530).2.52. Platform Offset Zirkon Okta Lock Abutment, 1.0 mmh (BM6531).2.53. Platform Offset Zirkon Okta Lock Abutment 2.0 mmh (BM6532).2.54. Platform Offset Titanium Okta Lock Abutment 0.5 mmh, Ti6Al4V (BM6533).2.55. Platform Offset Titanium Okta Lock Abutment 1.0 mmh, Ti6Al4V (BM6534).2.56. Platform Offset Titanium Okta Lock Abutment 15 degr., Ti6Al4V (BM6535).2.57. Okta Abutment GIO/GCO (BM6580).2.58. Titan cementing abutment GIO/GCO (BM6594).2.59. Titan lock abutment GIO/GCO (BM6596).2.60. Titan lock abutment, angulated 15 degr. GIO/GCO (BM6597).2.61. CMF Soldering Lock Abutment, 4mmh, CoCrMo (BM6614).2.62. Multiunit Abutment Xign 35 Degr. internally round, Ti6Al4V (BM7530).2.63. Multiunit Abutment Xign 20 Degr. internally round, Ti6Al4V (BM7531).2.64. Reverse cone abutment for Xign, 20 degr. incl. screw, Ti6Al4V (BM7532).2.65. Straight lock Abutment for GXi 3.0 2, Ti6Al4V (BM7591).2.66. Straight lock Abutment for GXi 3.0 3, Ti6Al4V (BM7592).2.67. Straight lock Abutment for GXi 3.0 5, Ti6Al4V (BM7593).2.68. Straight lock Abutment for GXi 3.4 1, Ti6Al4V (BM7594).2.69. Straight lock Abutment for GXi 3.4 2, Ti6Al4V (BM7595).2.70. Straight Abutment for GXi 3.4 3, Ti6Al4V (BM7596).2.71. Straight lock Abutment for GXi 3.4 5, Ti6Al4V (BM7597).2.72. Straight lock Abutment for GXi 3.4 8, Ti6Al4V (BM7598).2.73. Straight lock Abutment for GXi 3.8 1, Ti6Al4V (BM7599).2.74. Straight lock Abutment for GXi 3.8 2, Ti6Al4V (BM7600).2.75. Straight lock Abutment for GXi 3.8 3, Ti6Al4V (BM7601).2.76. Straight lock Abutment for GXi 3.8 5, Ti6Al4V (BM7602).2.77. Straight lock Abutment for GXi 4.5 1, Ti6Al4V (BM7603).2.78. Straight lock Abutment for GXi 4.5 2, Ti6Al4V (BM7604).2.79. Straight lock Abutment for GXi 4.5 3, Ti6Al4V (BM7605).2.80. Angulated lock Abutment GXi 3.4 1, 15 Degr.Ti6Al4V (BM7606).2.81. Angulated lock Abutment GXi 3.4 2, 15 Degr.Ti6Al4V (BM7607).2.82. Angulated lock Abutment GXi 3.4 3, 15 Degr.Ti6Al4V (BM7608).2.83. Angulated lock Abutment GXi 3.8 1, 15 Degr.Ti6Al4V (BM7609).2.84. Angulated lock Abutment GXi 3.8 2, 15 Degr.Ti6Al4V (BM7610).2.85. Angulated lock Abutment GXi 3.8 4, 15 Degr.Ti6Al4V (BM7611).2.86. Angulated lock Abutment GXi 4.5/5.5 1, 15 Degr.Ti6Al4V (BM7612).2.87. Angulated lock Abutment GXi 4.5/5.5 2, 15 Degr.Ti6Al4V (BM7613).2.88. Angulated lock Abutment GXi 4.5/5.5 4, 15 Degr.Ti6Al4V (BM7614).2.89. Abutment for GDV 3.8 1 (BM7616).2.90. Abutment for GDV 3.8 2 (BM7617).2.91. Abutment for GDV 3.8 1, 15 (BM7618).2.92. Screw-on Abutment GXi 3.4 2, Ti6Al4V (BM7635).2.93. Screw-on Abutment GXi 3.8 2, Ti6Al4V (BM7636).2.94. Screw-on Abutment GXi 3.8 4, Ti6Al4V (BM7637).2.95. Screw-on Abutment GXi 4.5/5.5 2, Ti6Al4V (BM7638).2.96. Screw-on Abutment GXi 4.5/5.5 4, Ti6Al4V (BM7706).3. Аналоги:3.1. Abutment analog for angulation adapter, AL (BM1309).3.2. GCS/GBC Implant analog with 5 sleeves, AL/Plastic (BM1314).3.3. Analog for GCS/GBC, AL (BM1315).3.4. Implant analog for GCS/GBC small, pack of 5, Plastic (BM1316).3.5. Abutment analog, AL (BM1321).3.6. GIH Sleeve analog, small, with 5 sleeves, AL/Plastic (BM1396).3.7. GIH Sleeve Analog, large, with 5 sleeves, AL/Plastic (BM1397).3.8. Analog for GCS K. Ti6Al4V (BM1324).3.9. GIH Implant analog, NS (BM3103).3.10. GIH Implant analog for DualHex, NS (BM3104).3.11. GIH M-Analog for DualHex, small, AL/Plastic (BM3108).3.12. GIH M-Analog, small, AL/Plastic (BM3109).3.13. Analog for screw on abutment, Ti6Al4V (BM3118).3.14. Analog for srew abutment, Ti6Al4V (BM3126).3.15. External Okta Analog (BM6584).3.16. Bezeichnung Biomed (BM6585).3.17. Plastic analog with brass core, GIO/GCO, 4 pc. (BM6590).3.18. Aluminium Analog with brass core, GIO/GCO, 4 pc. (BM6591).3.19. Implant Analogue GXi 3.4 (BM7627).3.20. Implant Analogue GXi 3.8 (BM7628).3.21. Implant Analogue GXi 4.5/5.5 (BM7629).3.22. Implant Analogue GDv 3.8 (BM7630).3.23. Sleeve Analogue GXi 3.4 (BM7631).3.24. Sleeve Analogue GXi 3.8 (BM7632).3.25. Sleeve Analogue GXi 4.5/5.5 (BM7633).3.26. Laboratory analog for Multiunit, Ti6Al4V (BM3150).3.27. IAB M-Laboranalog kompl. zu TOI Typ B, Al/Plastic-C (BM5099).3.28. Implant analog with 5 sleeves, AL/Plastic (BM5119).3.29. Implant analog, pack of 5, Plastic (BM5120).3.30. Implant analog GIO/GCO (BM6572).3.31. Implant Sleve Analog GIO/GCO (BM6573).4. Стержни для слепков:4.1. Impression post,internally round, AL (BM1311).4.2. Impression post, anti-rotation, AL (BM1312).4.3. Impression post 5, for TOI/GBC large head, pack of 5, Plastic (BM1393).4.4. Impression post round, for GBC/GCS, pack of 5, Plastic (BM1394).4.5. Impression post 4K, for GBC/GCS, pack of 5, Plastic (BM1395).4.6. Impression post for screw on abutments, Ti6Al4V (BM3117).5. Колпачки выжигаемые:5.1. Castable crown base for GBC/GCS, int. round, Plastic (BM1317).5.2. Castable crown base for GBC/GCS, anti rotation, Plastic (BM1318).5.3. Cap for GCS K, Plastic (BM1358).5.4. Nylon cap white, 1200 g (BM1325).5.5. Nylon cap pink, 800 g (BM1326).5.6. Nylon cap yellow, 500 g (BM1327).5.7. Bar Coping for GIH, internaly round, CoCrMo (BM3061).5.8. Burnout piece 12mm, round, Plastic (BM3127).5.9. Burnout piece 12mm, anti rotation, Plastic (BM3128).5.10. Burnout piece incl. metal base, Ti6Al4V/Plastic (BM3130).6. Ретракторы десневые:6.1. Gingiva retractor for GCS E, Plastic (BM1319).6.2. Gingiva-Retraktor, Plastic (BM1357).7. Винты:7.1. GIH Surgical Screw, 5.5mm, Ti6Al4V (BM3029).7.2. GIH Surgical Screw, 2.9/3.7/4.5mm, Ti6Al4V (BM3037).7.3. GIH straight screw on Abutment, 3mmh, Ti6Al4V (BM3113).7.4. GIH straight screw on Abutment, 4mmh, Ti6Al4V (BM3114).7.5. GIH straight screw on Abutment, 5mmh, Ti6Al4V (BM3115).7.6. GIH straight screw on Abutment, 6mmh, Ti6Al4V (BM3116).7.7. Screw for abutment bridges/bases, Ti6Al4V (BM3120).7.8. Screw long, Ti6Al4V (BM3125).7.9. Screw for multiunits, Ti6Al4V (BM3153).7.10. Drive screw 6mml, Wst. pack of 5, Ti6Al4V (BM5090).7.11. Drive screw 9mml, Wst. pack of 5, Ti6Al4V (BM5091).7.12. Bone screw 2.4 6, yellow, pack of 5, Ti6Al4V (BM5092).7.13. Bone screw 2.4 8, yellow, pack of 5, Ti6Al4V (BM5093).7.14. Bone screw 2.4 10, yellow, pack of 5, Ti6Al4V (BM5094).7.15. Bone screw 2.7 8, yellow, pack of 5, Ti6Al4V (BM5095).7.16. Bone screw 2.7 10, yellow, pack of 5, Ti6Al4V (BM5096).7.17. Healing Screw 2 mm GIO/GCO (BM6549).7.18. Healing Screw 4 mm GIO/GCO (BM6550).7.19. Healing Screw 5 mm GIO/GCO (BM6551).7.20. Surgical Screw GIO/GCO (BM6554).7.21. Screw for Okta Lock Transfer (BM6579).7.22. Prosthetical Screw 365 (BM6582).7.23. Prosthetical Screw 415 (BM6583).7.24. Screw for Titan lock abutment (BM6598).7.25. Abutment Transfer Screw M2 (BM6599).7.26. Abutment Transfer Screw, long, M2 (BM6600).7.27. Prosthetical Screw 350 (BM6588).7.28. Surgical Screw GXI 3.0, Ti6Al4V (BM7571).7.29. Surgical Screw GXI 3.4, Ti6Al4V (BM7572).7.30. LOC GIO 2.5 (BM6592).7.31. LOC GIO 4 (BM6593).7.32. Surgical Screw GXI 3.8, Ti6Al4V (BM7573).7.33. Surgical Screw GXI 4.5, Ti6Al4V (BM7574).8. Основы:8.1. TempBase®, protection cap, Plastic (BM1320).8.2. GCS/GBC Temporary base, Ertacetal (BM1300).8.3. GCS Cementable ball, Ti6Al4V (BM1301).8.4. Gold base for low-fusing gold alloys, Au (BM3144).8.5. Gold base for high-fusing gold alloys, Au (BM3145).8.6. Temporary base 2mmh for GIO (BM6547).8.7. Temporary base 4mmh for GIO (BM6548).8.8. Crown-Base 1, for TCA, CoCrMo (BM6604).8.9. Soldering Base for GXI, CoCrMo (BM7533).8.10. Temporary Base Gxi 3.4 3, Plastic/Ti6Al4V (BM7587).8.11. Temporary Base Gxi 3.8 3, Plastic/Ti6Al4V (BM7588).8.12. Temporary Base Gxi 4.5 3, Plastic/Ti6Al4V (BM7589).8.13. Temporary Base Gxi 3.0, Plastic/Ti6Al4V (BM7590).8.14. Castable crown base Gxi (BM7615).9. Гильзы:9.1. Steel housing for Nylon caps, SS (BM1329).9.2. Guide jacket for pilot drill (BM6537).10. Трансферы:10.1. Transfer post, Ti6Al4V (BM3124).10.2. Multiunit transfer coping, temporary base, Ti6Al4V (BM3151).10.3. Multiunit transfer straight, Ti6Al4V (BM3152).10.4. Okta Lock Transfer GIO (BM6571).10.5. Ext. Okta Transfer GIO/GCO (BM6581).10.6. Long Transfer GXi 3.0, Ti6Al4V (BM7619).10.7. Long Transfer GXi 3.4, Ti6Al4V (BM7620).10.8. Long Transfer GXi 3.8, Ti6Al4V (BM7621).10.9. GIH Closed Tray Post, long, NS (BM3105).10.10. GIH Closed Tray post, short, NS (BM3106).10.11. GIH Pick Up Post, NS (BM3107).10.12. Long Transfer GXi 4.5/5.5, Ti6Al4V (BM7622).10.13. Lock Transfer GXi 3.0, Ti6Al4V (BM7623).10.14. Lock Transfer Gxi 3.4, Ti6Al4V (BM7624).10.15. Lock Transfer GXi 3.8, Ti6Al4V (BM7625).10.16. Lock Transfer GXi 4.5/5.5, Ti6Al4V (BM7626).11. Локалайзеры:11.1. Localicer for GIH, 2mmh, Ti6Al4V (BM3140).11.2. Localicer for GIH, 4mmh, Ti6Al4V (BM3141).11.3. Localicer: Analog and impression cap, AL (BM3142).11.4. Localicer: set with 4 caps and 1 Housing (BM3143).11.5. Localicer for Multiunit, Ti6Al4V (BM3148).11.6. Localicer Implant A, Ti6Al4V (BM1200).11.7. Localicer Implant B, Ti6Al4V (BM1201).11.8. Localizer GXi 3.4 2, Ti6Al4V (BM7643).11.9. Localizer GXi 3.4 3, Ti6Al4V (BM7644).11.10. Localizer GXi 3.4 4, Ti6Al4V (BM76450).11.11. Localizer GXi 3.8 2, Ti6Al4V (BM764).11.12. Localizer GXi 3.8 3, Ti6Al4V (BM7647).11.13. Localizer GXi 3.8 4, Ti6Al4V (BM7648).11.14. Localizer GXi 4.5/5.5 2, Ti6Al4V (BM7649).11.15. Localizer GXi 4.5/5.5 3, Ti6Al4V (BM7650).11.16. Localizer GXi 4.5/5.5 4, Ti6Al4V (BM7651).12. Цилиндры фрезерующие:12.1. Milling cylinder Gxi 3.0, Ti6Al4V (BM7639).12.2. Milling cylinder Gxi 3.4, Ti6Al4V (BM7640).12.3. Milling cylinder Gxi 3.8, Ti6Al4V (BM7641).12.4. Milling cylinder Gxi 4.5/5.5, Ti6Al4V (BM7642).13. Абатмент выжигаемый: 13.1. Castable for BM 3110, Plastik (BM3110).13.2. Castable for BM 3045, 3046, Plastik (BM3111).13.3. Castable for Platform Offset Abutments, Plastic (BM6536).13.4. Castable GIO/GCO (BM6575).13.5. Castable 15 Degr. GIO/GCO (BM6576).13.6. Castable 20 Degr. GIO/GCO (BM6577).13.7. Castable 25 Degr. GIO/GCO (BM6578).13.8. External Okta Castable, antirotation (BM6586).13.9. External Okta Castable, round (BM6587).13.10. Biomed Castable for Straight Lock Abumtents, Plastic (BM7634).14. Формирователи десны:14.1. Healing Screw GXi 3.0 2, Ti6Al4V (BM7579).14.2. Healing Screw GXi 3.0 4, Ti6Al4V (BM7580).14.3. Healing Screw GXi 3.4 2, Ti6Al4V (BM7581).14.4. Healing Screw Gxi 3.4 4, Ti6Al4V (BM7582).14.5. Healing Screw GXi 3.8 2, Ti6Al4V (BM7583).14.6. Healing Screw GXI 3.8 4, Ti6Al4V (BM7584).14.7. Healing Screw GXI 4.5 2, Ti6Al4V (BM7585).14.8. Healing Screw GXI 4.5 4, Ti6Al4V (BM7586).14.9. Gingiva Shaper 3mm, Ti6Al4V (BM3165).14.10. Gingiva Shaper 5mm, Ti6Al4V (BM3166).

    Наименование организации – заявителя

    ООО "Результат-Аудит"

    Место нахождения организации-заявителя

    127572, Россия, г. Москва, ул. Клинская, д.6, оф.212

    Юридический адрес организации-заявителя

    127572, Россия, г. Москва, ул. Абрамцевская, д. 14А

    Наименование организации-производителя или организации-изготовителя

    "Доктор Иде Денталь АГ"

    Место нахождения организации-производителя или организации – изготовителя

    , Швейцария, Дальнее зарубежье, Dr. Ihde Dental AG, Dorfplatz 11, CH-8737 Gommiswald, Switzerland

    Юридический адрес организации-производителя или организации – изготовителя

    , Швейцария, Дальнее зарубежье, Dr. Ihde Dental AG, Dorfplatz 11, CH-8737 Gommiswald, Switzerland

    ОКП/ОКПД2

    94 3800

    Класс потенциального риска применения медицинского изделия

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    Назначение медицинского изделия, установленное производителем

    Адрес места производства или изготовления медицинского изделия

    Dorfplatz 11, CH-8737 Gommiswald, Switzerland

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    Контакты дистрибутора в России №1

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