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
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
По надзору в сфере здравоохранения
Ф.И.О
(печать)
_подпись_
_подпись_