ФСЗ 2010/06758

Регистрационное удостоверение на медицинское изделие ФСЗ 2010/06758
ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ В СФЕРЕ
ЗДРАВООХРАНЕНИЯ
(РОСЗДРАВНАДЗОР)
РЕГИСТРАЦИОННОЕ УДОСТОВЕРЕНИЕ
НА МЕДИЦИНСКОЕ ИЗДЕЛИЕ
от 02.07.2018 № ФСЗ 2010/06758
На медицинское изделие
Инструменты стоматологические марки Straumann для дентальной имплантации в наборах и отдельных упаковках с принадлежностямиI. Инструменты стоматологические марки Straumann для дентальной имплантации в наборах: 1. Набор остеотомов для поднятия дна синуса (Osteotome instrument kit, for sinus floor elevation) (вид 120400): - Остеотом Osteotome straight, for sinus floor elevation: Ø2.8 mm; Ø3.5 mm; Ø4.2 mm; - Остеотом Osteotome angled, for sinus floor elevation: Ø2.8 mm; Ø3.5 mm; Ø4.2 mm; - Ограничитель глубины Depth stop for osteotomes: Ø2.8 mm; Ø3.5 mm; Ø 4.2 mm. 2. Набор остеотомов для уплотнения кости (Osteotome instrument kit, for bone condensation): - Остеотом Osteotome straight, for bone condensation: Ø2.2 mm; Ø2.8 mm; Ø3.5 mm; Ø4.2 mm; - Остеотом Osteotome angled, for bone condensation: Ø2.2 mm; Ø2.8 mm; Ø3.5 mm; Ø4.2 mm; - Ограничитель глубины Depth stop for osteotomes: Ø2.2 mm; Ø2.8 mm; Ø3.5 mm; Ø4.2 mm. 3. Набор сверл (Drill set, short/long, drill stop compatible for D mm implant): - Drill set, short, drill stop compatible for D 3.3mm implant, D 2.2, 2.8mm, length 33mm, single-patient use (арт. 040.440S); - Drill set, long, drill stop compatible for D 3.3mm implant, D 2.2, 2.8mm, length 41mm, single-patient use (арт. 040.441S); - Drill set, short, drill stop compatible for D 4.1mm implant, D 2.2, 2.8, 3.5mm, length 33mm, single-patient use (арт. 040.443S); - Drill set, long, drill stop compatible for D 4.1mm implant, D 2.2, 2.8, 3.5mm, length 41mm, single-patient use (арт. 040.444S); - Drill set, short, drill stop compatible for D 4.8mm implant, D 2.2, 2.8, 3.5, 4.2mm, length 33mm, single-patient use (арт. 040.446S); - Drill set, long, drill stop compatible for D 4.8mm implant, D 2.2, 2.8, 3.5, 4.2mm, length 41mm, single-patient use (арт. 040.447S). II. Инструменты стоматологические марки Straumann для дентальной имплантации в отдельных упаковках (виды: 275450, 300030, 300020, 121050, 125050, 333910, 236190, 236030, 238610, 182770, 182070, 118570, 162160, 181150, 147730, 147770, 120160): 1. Сверла профильные: - BL/NNC profile drill: Ø 3.3/4.1/4.8 mm, short/long; Ø 3.3/4.1/4.8, guided, L 37 mm; - SP Profile drill: WN, short/long, Ø 4.8 mm, L 23.8mm/32.8 mm; RN, short/long, Ø 3.3/4.1 mm, L 24mm/ 25mm/33mm/34 mm; - SP Profile drill: Ø 3.3/4.1 mm, RN, guided, L 35 mm; - TE Profile drill: Ø 3.3/4.1 mm, RN, guided, L 37 mm; - TE Profile drill: RN, short/long, Ø 3.3/4.1 mm, L 28mm/37 mm; WN, short/long, Ø 4.8 mm, L 28mm/37 mm; - BLT Profile Drill: short/long, Ø2.9/ 3.3 / 4.1/ 4.8 mm, L 25mm/ 33 mm; - BLT Profile Drill guided: Ø3.3 / 4.1/ 4.8 mm, L 36 mm; - Mucosa punch: Ø 3.4/4.0/4.7mm, guided, L 30 mm; - BL Bone Profiler Oval Platform Ø4mm, L 28mm; - Bone profiler for RN, L 28mm, needed guiding cylinder:049.082; - Bone profiler for WN, L 25mm, needed guiding cylinder:049.082; - BL Bone Profiler 1, Ø 5.2 mm, L 23mm; - BL Bone Profiler 2, Ø 6.6 mm, L 23mm; - BL Bone Profiler 3, Ø 6 mm, L 23mm. 2. Сверла шаровидные Round bur: Ø 2.3/3.1/1.4 mm. 3. Сверла игловидные: - Needle Drill, short, Ø 1.6mm, L 33mm; - Needle Drill, long, Ø 1.6mm, L 41mm. 4. Сверла направляющие: - Glide Hole Drill Ø 1.5 mm, stop=20 mm, L 37.0 mm; - Residual Ridge Drill Ø 1.25 mm, stop=16 mm, L 37.0 mm; - Pilot drill 1, short, Ø 2.2 mm, L 33 mm; - Pilot drill 1, long, Ø 2.2 mm, L 41 mm; - Pilot drill 2, short, Ø 2.8 mm, L 33 mm; - Pilot drill 2, long, Ø 2.8 mm, L 41 mm; - Pilot drill: Ø2.2 mm, short, 16mm, guided, L32 mm; Ø2.2 mm, long, 20 mm, guided, L36 mm; Ø2.2 mm, x-long, 24 mm, guided, L 40 mm; - BLT Drill: short/long, Ø 2.8/3.5/4.2mm, L 33 mm/ 41 mm; - BLT Pilot Drill: short/long, Ø 2.2mm, L 33/ 41 mm; - BLT Drill guided: Ø 2.8/3.5/4.2mm, short/medium/ long; - BLT Pilot Drill guided, Ø 2.2mm, short/medium/long. 5. Сверла спиральные: - Twist drill PRO: short, Ø 3.5mm, L 33mm; long, Ø 3.5mm, L 41mm; short, Ø 4.2mm, L 33mm; long, Ø 4.2mm, L 41mm; - Twist drill PRO: Ø 2.8mm, short, 16 mm, guided, L 32mm; Ø 2.8mm, long, 20 mm, guided, L 36mm; Ø 2.8mm, x-long, 24 mm, guided, L 40mm; - Twist drill PRO: Ø3.5 mm, short, 16 mm, guided, L 32mm; Ø3.5 mm, long, 20 mm, guided, L 36mm; Ø3.5 mm, x-long, 24 mm, guided, L 40mm; Ø4.2 mm, short, 16 mm, guided, L 32mm; Ø4.2 mm, long, 20 mm, guided, L 36mm; Ø4.2mm, x-long, 24 mm, guided, L 40mm. 6. Метчики: - BL/TE/NNC Tap f. adapter: f. Ø 3.3/4.1/4.8 mm implants, L 23mm; - S/SP Tap for adapter: Ø 3.3/4.1/4.8 mm, L 23 mm; - S/SP Tap for ratchet, short: Ø 3.3/4.1/4.8 mm, L 30 mm; - Tap, long: Ø 3.3/4.1mm, L 34 mm; - S/SP Tap for ratchet, long, Ø 4.8 mm, L 34 mm; - BL/TE/NNC Tap f. handpiece: Ø3.3/4.1/4.8 mm, guided, L 42 mm; - S/SP Tap f. handpiece: Ø3.3/4.1/4.8 mm, guided, L 42 mm; - Tap for transversal screw retention; - BLT Tap: Ø2.9/3.3/4.1/4.8 mm, L 25mm; - BLT Tap guided: Ø3.3/4.1/4.8 mm, L 42mm. 7. Остеотомы: - Osteotome straight, for bone condensation: Ø2.2 mm; Ø2.8 mm; Ø3.5 mm; Ø4.2 mm; - Osteotome angled, for bone condensation: Ø2.2 mm; Ø2.8 mm; Ø3.5 mm; Ø4.2 mm; - Osteotome straight, for sinus floor elevation: Ø2.8 mm; Ø3.5 mm; Ø4.2 mm; - Osteotome angled, for sinus floor elevation: Ø2.8 mm; Ø3.5 mm; Ø4.2 mm. 8. Цилиндры: - NC Guiding cylinder for Ø 3.3mm, BL Implant explantation; - RC Guiding cylinder for Ø 4.1mm/ 4.8mm, BL Implant explantation; - Guidе sleeve for implants Ø 4.1mm & Ø 3.5mm, Ø 4.2 mm, L 5.6mm; - Guiding sleeve for solid screw implants Ø 3.3mm; - Guide sleeve for implants Ø 4.8mm, Ø 4.9 mm, L 6.4mm; - Guide cylinder for implant Ø 4.1mm, Ø 4.2mm, L 10.5mm; - Guide cylinder for implant Ø 4.8mm, Ø 4.9mm, L 10.5mm; - Guide cylinder for implants Ø 3.3mm & Ø 3.5mm, Ø 3.6mm, L 10.5mm; - NC Guiding Cylinder for BL Bone Profiler, Ø 3.25mm, L 12.5mm; - RC Guiding Cylinder for BL Bone Profiler, Ø 3.7mm, L 12.5mm; - SC Guiding cylinder for Ø 2.9mm. 9. Инструмент диагностический: Diagnostic T, L 65mm. 10. Индикатор/глубиномер: - Bone Level implant distance indicator, L 100mm; - Implant distance indicator, L 100mm; - Distance Indicator Additional Component, for BLT Ø 2.9mm; - SC Position Indicator, oval, L 10mm; - Depth gauge Ø3.5mm, L 26mm; - Depth gauge Ø 4.2mm, L 26mm, for Ø 4.8mm implants; - Depth gauge with distance indicator Ø2.2/2.8mm, L 27mm; - Depth Gauge: Ø 2.8/3.5/4.2mm, L 27mm. 11. Штифты: - Alignment pin straight, Ø 2.2mm, L 28mm; - Transfer and Alignment Pin, for Screw-retained Abutments; - Template fixation pin: Ø5.0/2.8mm, guided, L 24 mm; Ø2.8/2.8mm, guided, L 25mm; Ø 5.0/3.5mm, guided, L 24mm; Ø5/4.2mm, guided, L 24mm; - Guide pin for reamer, for synOcta, L 50mm; - Guide pin for reamer; - SC Guiding Pin for BL Bone Profiler, Oval Platform, Ø2.85mm, L 6.4mm; - Alignment Pin Ø 2.2mm, L 27mm. 12. Адаптеры: - Adapter for ratchet: x-short/short/long; - Adapter for handpiece: x-short/short/long; - SP/NNC/TE Guided Adapter: for handpiece, L 23mm / for ratchet, L 16mm; - S Guided Adapter: for handpiece, L 24mm / for ratchet, L 17mm; - BL/BLT Guided Adapter: for handpiece, L 24mm / for ratchet, L 17mm. 13. Кольца Grommets for BL instruments for Surgical Cassette. 14. Инструмент для эксплантации: - 48 h Explantation device for BL Implant: NC/ RC; - 48h Explantation device, for Ø 2.9mm, L 29.7mm; - Explantation drill: medium, for Ø 2.9mm, L 37.5mm; long, for Ø 2.9mm, L 40mm; - Explantation drill: short/ medium/ long, for Ø 3.3/4.1/4.8mm. 15. Отвертки: - Screwdriver handle 1.5 with blade and screw-holding dev. for crosshead screws (арт. 040.360); - Solid abut. driver: short, f. RN solid abut. 6˚, L 13mm; long, f. RN solid abut. 6˚, L 19mm; - Retentive anchor driver L 19 mm; - Screwdriver, L 37 mm; - SCS Screwdriver, for ratchet: x-short / short / long; - AS Screwdriver for ratchet: extra-short / short / long; - SCS Screwdriver for handpiece: x-short / short / long; - AS Screwdriver for handpiece: extra-short / short / long; - TS Hexagonal screwdriver, L 24 mm; - Hexagonal screwdriver, L 30 mm; - Screwdriver for titanium matrix, L 50 mm; 16. Ключи: - Torque control device for ratchet; - Holding key; - Service instrument for ratchet, L 50 mm; - Ratchet, including service instrument, L 84 mm; - Connector for ratchet L 14 mm; - Stop key for guided implants S/SP/TE/BL; - Holding key, for screw-retained abutments, L 85mm. 17. Экстрактор: - Extractor for titanium matrix, L 100 mm. 18. Пинцеты: - Tweezers without titanium plasma-coated tips; - Tweezers with titanium plasma-coated tips; - Instrument Tweezers, L 140mm. 19. Рукоятки: - Screwdriver handle for 046.410/411/412; - Drill handle: Ø2.2mm, 1 mm /3 mm stop, L 104 mm; Ø2.8 mm, 1 mm /3 mm stop, L 104 mm; Ø3.5 mm, 1 mm /3 mm stop, L 104 mm; Ø4.2 mm, 1 mm /3 mm stop, L 104 mm; - C-handle H2, 6 mm stop height, L 89 mm; - C-handle H4, 4 mm stop height, L 89 mm; - C-handle H6, 2 mm stop height, L 89 mm; - Analog holder; - Handle for reamers and Tap for TS, L 65 mm. 20. Активатор Activator set, for all bar matrices three-part. 21. Деактиватор Deactivator for Dolder bar matrices: mini, regular, L 66 mm. 22. Шаблоны рентгеновские X-ray reference sphere Ø5 mm. 23. Щёточки: - Cleaning brush for ratchet; - TiBrush. 24. Гильзы: - Drill sleeve with collar; - Sleeve: Ø5 mm, H 5 mm, guided; Ø2.8 mm, H 6 mm, guided; - T-sleeve: Ø5 mm, H 5 mm, guided; Ø 2.8 mm, H 6 mm, guided. 25. Инструмент вспомогательный: - Reamer for 45° shoulder; - Drill Stop aid; - Screwdriver Handling Aid AS; - Release aid: S / N/ R/W for Loxim; - SC Polishing Aid, L16mm; - Planning guide. 26. Фрезы Milling cutter: Ø2.8/3.5/4.2 mm, guided L 32.5 mm. 27. Ограничители глубины Depth stop for osteotomes: Ø2.2/2.8/3.5/4.2 mm. III. Принадлежности: 1. Кассеты: - Straumann surgical cassette (арт. 040.165); - Prosthetic cassette for instruments (арт. 041.022); - Ultrasonic Cleaning Cassette; - Bone Block Fixation Сassette 1.5; - Surgical cassette, for guided surgery. 2. Контейнер Screw container with lid, for Straumann surgical cassette (арт. 041.047). 3. Винт процессинговый Lab Processing Screw, for Screw-retained Abutments.
Настоящее регистрационное удостоверение выдано
ООО "Штрауманн"
Производитель
"Институт Штрауманн АГ"
Место производства медицинского изделия
, Швейцария, Institut Straumann AG, Peter Merian-Weg 12, 4002 Basel, Switzerland
Номер регистрационного досье № ФСЗ 2010/06758
Вид медицинского изделия: см. приложение
Класс потенциального риска применения медицинского изделия: 2а
Код Общероссийского классификатора продукции для
медицинского изделия: 32.50.11.000
Приказом Росздравнадзора от 02.07.2018 № ________
Допущено к обращению на территории Российской Федерации.
Руководитель Федеральной службы
По надзору в сфере здравоохранения
Ф.И.О
(печать)

_подпись_