Данные о регистрационном удостоверении на Мн-7.120217/7.006-2304
- Помощь в регистрации медицинских изделий в Росздравнадзоре (РУ)
- Внесение изменений в действующее регистрационное удостоверение (ВИРД)
- Разработка всех необходимых документов для регистрации (подготовка регистрационного досье)
- Проведение испытаний (технические, клинические, токсикологические)
изделия медицинского назначения
Наименование
Инструментарий стоматологический эндодонтический: инструменты для препарирования корневого канала
Производитель
FKG Dentaire Sarl, ШВЕЙЦАРИЯ
Адрес: Le Cret-du-Locle 4, 2322 Le Cret-du-Locle
Производственная площадка
FKG Dentaire Sarl, ШВЕЙЦАРИЯ. Адрес: Le Cret-du-Locle 4, 2322 Le Cret-du-Locle
Заявитель
FKG Dentaire Sarl, ШВЕЙЦАРИЯ
Номер удостоверения
ИМ-7.107471/2305
Рег. номер товара
Мн-7.120217/7.006-2304
Состав
в составе:
01.7B0.00.0EO.FK Bio RaCe BR0, 8%, 19mm, # 25, handle DM; 01.7B0.00.0EP.FK Bio RaCe BR1, 5 %, 21mm # 15, handle DM; 01.7B0.00.0EQ.FK Bio RaCe BR2, 4 %, 21mm, # 25, handle DM; 01.7B0.00.0ER.FK; Bio RaCe BR3, 6 %, 21mm, # 25, handle DM; 01.7B0.00.0ES.FK Bio RaCe BR4, 4 %, 21mm, # 35, handle DM; 01.7B0.00.0ET.FK Bio RaCe BR5, 4 %, 21mm, # 40, handle DM; 01.7B0.00.0EU.FK Bio RaCe BR6, 4 %, 21mm, # 50, handle DM; 01.7B0.00.0EV.FK Bio RaCe BR7, 2 %, 21mm, # 60, handle DM; 01.7B0.00.0EW.FK Bio RaCe BR4C, 2 %, 21mm, # 35, handle DM; 01.7B0.00.0EX.FK Bio RaCe BR5C, 2 %, 21mm, # 40, hadle DM; 01.7B0.00.0EY.FK Bio RaCe BR1, 5 %, 25mm # 15, handle DM; 01.7B0.00.0EZ.FK Bio RaCe BR2, 4 %, 25mm, # 25, handle DM; 01.7B0.00.0FA.FK Bio RaCe BR3, 6 %, 25mm, # 25, handle DM; 01.7B0.00.0FB.FK Bio RaCe BR4, 4 %, 25mm, # 35, handle DM; 01.7B0.00.0FC.FK Bio RaCe BR5, 4 %, 25mm, # 40, handle DM; 01.7B0.00.0FD.FK Bio RaCe BR6, 4 %, 25mm, # 50, handle DM; 01.7B0.00.0FE.FK Bio RaCe BR7, 2 %, 25mm, # 60, handle DM; 01.7B0.00.0FF.FK Bio RaCe BR4C, 2 %, 25mm, # 35, handle DM; 01.7B0.00.0FG.FK Bio RaCe BR5C, 2 %, 25mm, # 40, hadle DM; 01.7B0.00.0FH.FK Bio RaCe BR1, 5 %, 31mm # 15, handle DM; 01.7B0.00.0FI.FK Bio RaCe BR2, 4 %, 31mm, # 25, handle DM; 01.7B0.00.0FJ.FK Bio RaCe BR3, 6 %, 31mm, # 25, handle DM; 01.7B0.00.0FK.FK Bio RaCe BR4, 4 %, 31mm, # 35, handle DM; 01.7B0.00.0FL.FK Bio RaCe BR5, 4 %, 31mm, # 40, handle DM; 01.7B0.00.0FM.FK Bio RaCe BR6, 4 %, 31mm, # 50, handle DM; 01.7B0.00.0FN.FK Bio RaCe BR7, 2 %, 31mm, # 60, handle DM; 01.7B0.00.0FO.FK Bio RaCe BR4C, 2 %, 31mm, # 35, handle DM; 01.7B0.00.0FP.FK Bio RaCe BR5C, 2 %, 31mm, # 40, hadle DM; S1.7B0.00.0FC.FK BT-Race 40: 4%, # 40, 21 mm, handle BT; S1.7B0.00.0FD.FK BT-Race 40: 4%, # 40, 25 mm, handle BT; S1.7B0.00.0FE.FK BT-Race 40: 4%, # 40, 31 mm, handle BT; S1.7B0.00.0FF.FK BT-Race 50: 4%, # 50, 21 mm, handle BT; S1.7B0.00.0FG.FK BT-Race 50: 4%, # 50, 25 mm, handle BT; S1.7B0.00.0FH.FK BT-Race 50: 4%, # 50, 31 mm, handle BT; S1.7B0.00.SCN.FK BT-Race: 2 x (BT1 6% # 10 handle CI + BT2 0% # 35 handle BT + BT3 4% # 35, 21 mm, handle BT); S1.7B0.00.SCO.FK BT-Race: 2 x (BT1 6% # 10 handle CI + BT2 0% # 35 handle BT + BT3 4% # 35, 25 mm, handle BT); S1.7B0.00.SCP.FK BT-Race: 2 x (BT1 6% # 10 handle CI + BT2 0% # 35 handle BT + BT3 4% # 35, 31 mm, handle BT); 01.7B0.00.SAA.FK iRaCe: R1, taper 6%, # 15 + R2, taper 4%, # 25 + R3, taper 4%, # 30, 25 mm, handle CI; 01.7B0.00.SAB.FK iRaCe Plus: 2 x R1a, taper 2%, # 20 + 2 x R1b, taper 2%, # 25, 25 mm, handle CI; 01.7B0.00.SAC.FK iRaCe: R1, taper 6%, #15 + R2, taper 4%, # 25 + R3, taper 4%, # 30, 21 mm, handle CI; 01.7B0.00.SAD.FK iRaCe Plus: 2 x R1a, taper 2%, # 20 + 2 x R1b, taper 2%, # 25, 21 mm, handle CI; 01.7B0.00.SAE.FK iRaCe: R1, taper 6%, # 15 + R2, taper 4%, # 25 + R3, taper 4%, № # 30, 31 mm, handle CI; 01.7B0.00.SAF.FK iRaCe Plus: 2 x R1a, taper 2%, # 20 + 2 x R1b, taper 2%, # 25, 31 mm, handle CI; S1.7B0.00.SAA.FK iRaCe: R1, 6%, # 15 + R2, 4%, # 25 + R3, 4%, # 30, 21 mm, handle court CI; S1.7B0.00.SAB.FK iRaCe: R1, 6%, # 15 + R2, 4%, # 25 + R3, 4%, # 30, 25 mm, handle court CI; S1.7B0.00.SAC.FK iRaCe: R1, 6%, # 15 + R2, 4%, # 25 + R3, 4%, # 30, 31 mm, handle court CI; S1.7B0.00.SAD.FK iRaCe Plus: 2 x R1a, 2%, # 20 + 2 x R1b, con. 2%, # 25, 21 mm, handle court CI; S1.7B0.00.SAE.FK iRaCe Plus: 2 x R1a, 2%, # 20 + 2 x R1b, con. 2%, # 25, 25 mm, handle court CI; S1.7B0.00.SAF.FK iRaCe Plus: 2 x R1a, 2%, # 20 + 2 x R1b, con. 2%, # 25, 31 mm, handle court CI; 01.7B0.00.0AA.FK RaCe 706 Ni-Ti, Taper 6%, 25 mm, Nr 15, handle CI; 01.7B0.00.0AB.FK RaCe 704 Ni-Ti, Taper 4%, 25 mm, Nr 25, handle CI; 01.7B0.00.0AC.FK RaCe 704 Ni-Ti, Taper 4%, 25 mm, Nr 30, handle CI; 01.7B0.00.0AE.FK RaCe 702 Ni-Ti, Taper 2%, 25 mm, Nr 25, handle CI; 01.7B0.00.0AF.FK RaCe 704 Ni-Ti, Taper 4%, 25 mm, Nr 35, handle CI; 01.7B0.00.0AG.FK RaCe 706 Ni-Ti, Taper 6%, 21 mm, Nr 15, handle CI; 01.7B0.00.0AH.FK RaCe 704 Ni-Ti, Taper 4%, 21 mm, Nr 25, handle CI; 01.7B0.00.0AI.FK RaCe 704 Ni-Ti, Taper 4%, 21 mm, Nr 30, handle CI; 01.7B0.00.0AK.FK RaCe 702 Ni-Ti, Taper 2%, 21 mm, Nr 25, handle CI; 01.7B0.00.0AL.FK RaCe 706 Ni-Ti, Taper 6%, 31 mm, Nr 15, handle CI; 01.7B0.00.0AM.FK RaCe 704 Ni-Ti, Taper 4%, 31 mm, Nr 25, handle CI; 01.7B0.00.0AN.FK RaCe 704 Ni-Ti, Taper 4%, 31 mm, Nr 30, handle CI; 01.7B0.00.0AP.FK RaCe 702 Ni-Ti, Taper 2%, 31 mm, Nr 25, handle CI; 01.7B0.00.0AS.FK RaCe 702 Ni-Ti, Taper 2%, 21 mm, # 30, handle CI; 01.7B0.00.0AT.FK RaCe 702 Ni-Ti, Taper 2%, 21 mm, # 35, handle CI; 01.7B0.00.0AU.FK RaCe 702 Ni-Ti, Taper 2%, 21 mm, # 40, handle CI; 01.7B0.00.0AV.FK RaCe 702 Ni-Ti, Taper 2%, 21 mm, # 45, handle CI; 01.7B0.00.0AW.FK RaCe 702 Ni-Ti, Taper 2%, 21 mm, # 50, handle CI; 01.7B0.00.0AX.FK; RaCe 702 Ni-Ti, Taper 2%, 21 mm, # 55, handle CI; 01.7B0.00.0AY.FKRaCe 702 Ni-Ti, Taper 2%, 21 mm, # 60, handle CI; 01.7B0.00.0BA.FK RaCe 702 Ni-Ti, Taper 2%, 25 mm, # 15, handle CI; 01.7B0.00.0BB.FK RaCe 704 Ni-Ti, Taper 4%, 25 mm, # 20, handle CI; 01.7B0.00.0BC.FK RaCe 702 Ni-Ti, Taper 2%, 25 mm, # 30, handle CI; 01.7B0.00.0BD.FK RaCe 702 Ni-Ti, Taper 2%, 25 mm, # 35, handle CI; 01.7B0.00.0BE.FK RaCe 702 Ni-Ti, Taper 2%, 25 mm, # 40, handle CI; 01.7B0.00.0BF.FK RaCe 702 Ni-Ti, Taper 2%, 25 mm, # 45, handle CI; 01.7B0.00.0BG.FK RaCe 702 Ni-Ti, Taper 2%, 25 mm, # 50, handle CI; 01.7B0.00.0BH.FK RaCe 702 Ni-Ti, Taper 2%, 25 mm, # 55, handle CI; 01.7B0.00.0BI.FK RaCe 702 Ni-Ti, Taper 2%, 25 mm, # 60, handle CI; 01.7B0.00.0BL.FK RaCe 702 Ni-Ti, Taper 2%, 31 mm, # 30, handle CI; 01.7B0.00.0BM.FK RaCe 702 Ni-Ti, Taper 2%, 31 mm, # 35, handle CI; 01.7B0.00.0BN.FK RaCe 702 Ni-Ti, Taper 2%, 31 mm, # 40, handle CI; 01.7B0.00.0BO.FK RaCe 702 Ni-Ti, Taper 2%, 31 mm, # 45, handle CI; 01.7B0.00.0BP.FK RaCe 702 Ni-Ti, Taper 2%, 31 mm, # 50, handle CI; 01.7B0.00.0BQ.FK RaCe 702 Ni-Ti, Taper 2%, 31 mm, # 55, handle CI; 01.7B0.00.0BR.FK RaCe 702 Ni-Ti, Taper 2%, 31 mm, # 60, handle CI; 01.7B0.00.0BT.FK RaCe 704 Ni-Ti, Taper 4 %, 21 mm, # 15, handle CI; 01.7B0.00.0BU.FK RaCe 704 Ni-Ti, Taper 4 %, 21 mm, # 20, handle CI; 01.7B0.00.0BV.FK RaCe 704 Ni-Ti, Taper 4%, 21 mm, # 35, handle CI; 01.7B0.00.0BW.FK RaCe 704 Ni-Ti, Taper 4%, 21 mm, # 40, handle CI; 01.7B0.00.0BX.FK RaCe 704 Ni-Ti, Taper 4%, 21 mm, # 50, handle CI; 01.7B0.00.0BZ.FK Race 704 Ni-Ti, Taper 4%, 25 mm, # 15, handle CI; 01.7B0.00.0CA.FK RaCe 704 Ni-Ti, Taper 4%, 25 mm, # 40, handle CI; 01.7B0.00.0CB.FK RaCe 704 Ni-Ti, Taper 4%, 25 mm, # 50, handle CI; 01.7B0.00.0CD.FK RaCe 704 Ni-Ti, Taper 4%, 31 mm, # 15, handle CI; 01.7B0.00.0CE.FK RaCe 704 Ni-Ti, Taper 4%, 31 mm, # 20, handle CI; 01.7B0.00.0CF.FK RaCe 704 Ni-Ti, Taper 4%, 31 mm, # 35, handle CI; 01.7B0.00.0CG.FK RaCe 704 Ni-Ti, Taper 4%, 31 mm, # 40, handle CI; 01.7B0.00.0CH.FK RaCe 704 Ni-Ti, Taper 4%, 31 mm, # 50, handle CI; 01.7B0.00.0CJ.FK RaCe 706 Ni-Ti, Taper 6%, 21 mm, # 20, handle CI; 01.7B0.00.0CK.FK RaCe 706 Ni-Ti, Taper 6%, 21 mm, # 25, handle CI; 01.7B0.00.0CL.FK RaCe 706 Ni-Ti, Taper 6%, 21 mm, # 30, handle CI; 01.7B0.00.0CN.FK RaCe 706 Ni-Ti, Taper 6%, 25 mm, # 20, handle CI; 01.7B0.00.0CO.FK RaCe 706 Ni-Ti, Taper 6%, 25 mm, # 25, handle CI; 01.7B0.00.0CP.FK RaCe 706 Ni-Ti, Taper 6%, 25 mm, # 30, handle CI; 01.7B0.00.0CQ.FK RaCe 706 Ni-Ti, Taper 6%, 25 mm, # 40, handle CI; 01.7B0.00.0CS.FK RaCe 706 Ni-Ti, Taper 6%, 31 mm, # 20, handle CI; 01.7B0.00.0CT.FK RaCe 706 Ni-Ti, Taper 6%, 31 mm, # 25, handle CI; 01.7B0.00.0CU.FK RaCe 706 Ni-Ti, Taper 6%, 31 mm, # 30, handle CI; 01.7B0.00.0CV.FK RaCe 706 Ni-Ti, Taper 6%, 31 mm, # 35, handle CI; 01.7B0.00.0CW.FK RaCe 706 Ni-Ti, Taper 6%, 31 mm, # 40, handle CI; 01.7B0.00.0CX.FK RaCe 706 Ni-Ti, Taper 6%, 21 mm, # 35, handle CI; 01.7B0.00.0CY.FK RaCe 706 Ni-Ti, Taper 6%, 21 mm, # 40, handle CI; 01.7B0.00.0CZ.FK RaCe 706 Ni-Ti, Taper 6%, 25 mm, # 35, handle CI; S1.XB0.00.0AF.FK XP-endo Shaper, # 30, 21 mm (x6); S1.XB0.00.0AG.FK XP-endo Shaper, # 30, 25 mm (x6); S1.XB0.00.0AH.FK XP-endo Shaper, # 30, 31 mm (x6); S1.XB0.00.0AJ.FK XP-endo Shaper, # 30, 21 mm (x3); S1.XB0.00.0AK.FK XP-endo Shaper, # 30, 25 mm (x3); S1.XB0.00.0AL.FK XP-endo Shaper, # 30, 31 mm (x3); S1.XB0.00.SAA.FK XP-endo Shaper sequence 21mm: 2x (1x K-file # 10, 1x K-file # 15, 1x XP-endo Shaper); S1.XB0.00.SAB.FK XP-endo Shaper sequence 25mm: 2x (1x K-file # 10, 1x K-file # 15, 1x XP-endo Shaper); S1.XB0.00.SAC.FK XP-endo Shaper Plus sequence 21mm: 2x (1x K-file #10, 1x K-file #15, 1x XP-endo Shaper, 1x XP-endo Finisher # 25); S1.XB0.00.SAD.FK XP-endo Shaper Plus sequence 25mm: 2x (1x K-file # 10, 1x K-file # 15, 1x XP-endo Shaper, 1x XP-endo Finisher # 25)
01.7B0.00.SAG.FK Базовый набор Bio RaCe (Basic set Bio RaCe): BR0, 19 mm, # 25, con. 8%, + BR1, 25 mm, # 15, taper 5% + BR2, 25 mm, # 25, taper 4%, + BR3, 25 mm, # 25, taper 6 % + BR4, 25 mm, # 35, taper 4 % + BR5, 25 mm, # 40, taper 4% handle DM;
01.7B0.00.SAH.FK Расширенный набор Bio RaCe (Extended Set Bio RaCe): BR6, 25 mm, # 50, taper 4% + BR7, 25 mm, # 60, taper 2% + BR4C, 25 mm, # 35, taper 2 % + BR5C, 25 mm, # 40, taper 2 %, handle DM;
01.7B0.00.SAJ.FK Базовый набор Bio RaCe (Basic set Bio RaCe): BR0, 19 mm, # 25, con. 8%, + BR1, 21 mm, # 15, taper 5% + BR2, 21 mm, # 25, taper 4%, + BR3, 21 mm, # 25, taper 6 % + BR4,21 mm, # 35, taper 4 % + BR5, 21 mm, # 40, taper 4% handle DM;
01.7B0.00.SAK.FK Базовый набор Bio RaCe (Basic set Bio RaCe): BR0, 19 mm, # 25, con. 8%, + BR1, 31 mm, # 15, taper 5% + BR2, 31 mm, # 25, taper 4%, + BR3, 31 mm, # 25, taper 6 % + BR4,31 mm, # 35, taper 4 % + BR5, 31 mm, # 40, taper 4% handle DM;
01.7B0.00.SAL.FK Расширенный набор Bio RaCe (Extended Set Bio RaCe): BR6, 21 mm, # 50, taper 4% + BR7, 21 mm, # 60, taper 2% + BR4C, 21 mm, # 35, taper 2 % + BR5C, 21 mm, # 40, taper 2 %, handle DM;
01.7B0.00.SAM.FK Расширенный набор Bio RaCe (Extended Set Bio RaCe): BR6, 31 mm, # 50, taper 4% + BR7, 31 mm, # 60, taper 2% + BR4C, 31 mm, # 35, taper 2 % + BR5C, 31 mm, # 40, taper 2 %, handle DM
Назначение
В соответствии с инструкцией по использованию
Дата регистрации
2019-05-28 16:54:24
Срок действия
2024-05-28 16:54:24