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Dispositivos MédicosAtivo

osstem instrumental 5

82285310026
Informações Gerais

Nome do produto

osstem instrumental 5

Número de registro

82285310026

Nome técnico

Instrumento Cirurgico Para Implantes Dentarios

Classe de risco

I

Processo

25351226755202205

Empresa Detentora

Razão social

OSSTEM IMPLANT BRASIL LTDA

CNPJ

32.356.774/0001-46

Fabricante

OSSTEM IMPLANT CO., LTD

País de fabricação

CORÉIA DO SUL

Registro

Situação

Ativo

Vencimento

Registro vigente

Validade prevista: 04/08/2027

Histórico de Situação
VálidoATIVO07/05/2026

Detectado a cada sincronização diária com a ANVISA.

Apresentações / Modelos(156)

  • ABBE52L

    BONE EJECTOR 104 (L)

  • AHD09LH

    HANDE DRIVER 8.0 D(Ø) X 28.0 (L) - LONGO

  • AHD09MSH

    HANDE DRIVER 8.0 D(Ø) X 15.0 (L) - CURTO

  • AHD09SH

    HANDE DRIVER 8.0 D(Ø) X 23.0 (L) - CURTO

  • AHD12EH

    HANDE DRIVER 8.0 D(Ø) X 35.0 (L) - LONGO

  • AHD12LH

    HANDE DRIVER 8.0 D(Ø) X 28.0 (L) - LONGO

  • AHD12MH

    HANDE DRIVER 8.0 D(Ø) X 25.0 (L) - LONGO

  • AHD12MSH

    HANDE DRIVER 8.0 D(Ø) X 15.0 (L) - CURTO

  • AHD12SH

    HANDE DRIVER 8.0 D(Ø) X 23.0 (L) - CURTO

  • APG201

    POSITIONING GUIDE 5.0 D(Ø) X 21.5 (L)

  • APG202

    POSITIONING GUIDE 8.0 D(Ø) X 17.5 (L)

  • APG203

    POSITIONING GUIDE 13.0 D(Ø) X 17.5 (L)

  • ASD05LH

    HANDE DRIVER 8.0 D(Ø) X 28.0 (L) - LONGO

  • ASD05SH

    HANDE DRIVER 8.0 D(Ø) X 23.0 (L) - CURTO

  • CITQW-1185A

    RATCHET WRENCH 12.0 D(Ø) X 85.25 (L)

  • ESD60S

    EXCELLENT SOLID ABUTMENT DRIVER 6.0 D(Ø) X 16.5 (L) - SQUARE

  • FRSDM23

    SCREW DRIVER 3.5 D(Ø) X 18.5 (L) – MINI

  • FRSDR25

    SCREW DRIVER 4.1 D(Ø) X 18.5 (L) – REGULAR

  • FRSDW30

    SCREW DRIVER 4.6 D(Ø) X 18.5 (L) – LARGO

  • FRTE480

    REAMER TIP 4.1 D(Ø) X 50.0 (L)

  • FRTE600

    REAMER TIP 5.0 D(Ø) X 50.0 (L)

  • FRTS480

    REAMER TIP 3.22 D(Ø) X 50.0 (L)

  • FRTS600

    REAMER TIP 3.4 D(Ø) X 50.0 (L)

  • GSNMT32E

    NOMOUNT TORQUE DRIVER 3.2 D(Ø) X 28.3 (L) - TS

  • GSNMT32L

    NOMOUNT TORQUE DRIVER 3.2 D(Ø) X 21.3 (L) - TS

  • GSNMT32S

    NOMOUNT TORQUE DRIVER 3.2 D(Ø) X 14.3 (L) - TS

  • GSNMT35E

    NOMOUNT TORQUE DRIVER 3.5 D(Ø) X 28.3 (L) - TS

  • GSNMT35L

    NOMOUNT TORQUE DRIVER 3.5 D(Ø) X 21.3 (L) - TS

  • GSNMT35S

    NOMOUNT TORQUE DRIVER 3.5 D(Ø) X 14.3 (L) - TS

  • GSRFRT400

    REAMER TIP 3.32 D(Ø) X 50.0 (L)

  • GSRFRT450

    REAMER TIP 3.9 D(Ø) X 50.0 (L)

  • GSRFRT500

    REAMER TIP 4.18 D(Ø) X 50.0 (L)

  • GSRFRT600

    REAMER TIP 4.93 D(Ø) X 50.0 (L)

  • HST75

    BONE SEPARATOR 7.0 D(Ø) X 76.7 (L)

  • IHD20H

    HANDE DRIVER 8.0 D(Ø) X 21.0 (L) - 2.0 INT.HEX

  • IHD27H

    HANDE DRIVER 8.0 D(Ø) X 21.0 (L) - 2.7 INT.HEX

  • MX30

    TORQUE WRENCH SET TW30CB + ORC

  • ORD45L

    TS RIGID OUTER DRIVER 4.95 D(Ø) X 21.5 (L)

  • ORD45S

    TS RIGID OUTER DRIVER 4.95 D(Ø) X 16.5 (L)

  • ORTR18

    RE-TAP 2.35 D(Ø) X 30.5 (L)

  • OTSD07

    SLOT DRIVER 5.0 D(Ø) X 21.5 (L)

  • SD60S

    SOLID ABUTMENT DRIVER 5.0 D(Ø) X 16.5 (L) - SQUARE

  • SNBC1114

    BONE CONDENSER 1.1 D(Ø) X 1.4 D(Ø) X 174 (L)

  • SNBCH30

    BONE CARRIER 3.0 D(Ø) X 36.9 (L) - BONE CARRIER HEAD

  • SNBCH35

    BONE CARRIER 3.5 D(Ø) X 36.9 (L) - BONE CARRIER HEAD

  • SNBCS35

    SNBCH35 + MJH

  • SSNMT39L

    NOMOUNT TORQUE DRIVER 3.9 D(Ø) X 27.2 (L) - SS

  • SSNMT39S

    NOMOUNT TORQUE DRIVER 3.9 D(Ø) X 17.2 (L) - SS

  • TIHD20L

    TORQUE DRIVER 3.4 D(Ø) X 19.5 (L) - LONG / 2.0 INT.HEX

  • TIHD20S

    TORQUE DRIVER 3.4 D(Ø) X 15.5 (L) - SHORT / 2.0 INT.HEX

  • TIHD27

    TORQUE DRIVER 3.7 D(Ø) X 15.5 (L) - LONG / 2.7 INT.HEX

  • TRHD09L

    TORQUE DRIVER 2.0 D(Ø) X 26.5 (L) - LONG / 0.9 HEX

  • TRHD09S

    TORQUE DRIVER 2.0 D(Ø) X 19.5 (L) - SHORT / 0.9 HEX

  • TRHD12E

    TORQUE DRIVER FOR TORQUE WRENCH 2.1 D(Ø) X 31.5 (L)

  • TRHD12L

    TORQUE DRIVER FOR TORQUE WRENCH 2.1 D(Ø) X 26.5 (L)

  • TRHD12LR

    REPAIR TORQUE DRIVER FOR TORQUE WRENCH 1.6 D(Ø) X 26.5 (L) - LONGO

  • TRHD12M

    TORQUE DRIVER FOR TORQUE WRENCH 2.1 D(Ø) X 21.5 (L)

  • TRHD12MS

    TORQUE DRIVER FOR TORQUE WRENCH 2.1 D(Ø) X 14.5 (L)

  • TRHD12S

    TORQUE DRIVER FOR TORQUE WRENCH 2.1 D(Ø) X 19.5 (L)

  • TRHD12SR

    REPAIR TORQUE DRIVER FOR TORQUE WRENCH 1.6 D(Ø) X 19.5 (L) - CURTO

  • TRSD05E

    TORQUE DRIVER FOR TORQUE WRENCH 0.47 D(Ø) X 31.5 (L)

  • TRSD05L

    TORQUE DRIVER FOR TORQUE WRENCH 0.47 D(Ø) X 26.5 (L)

  • TRSD05S

    TORQUE DRIVER FOR TORQUE WRENCH 0.47 D(Ø) X 19.5 (L)

  • TW30B

    TORQUE WRENCH 11.2 D(Ø) X 104.4 (L) - OSSTEM

  • TW30CB

    TORQUE WRENCH SET 11.0 D(Ø) X 88.1 (L)

  • TW400B

    TORQUE WRENCH 11.2 D(Ø) X 121.0 (L)

  • ABM ABMH + ABMC + ABMG + ABMB – BONE MILL SET

  • ABMB BONE MILL 73.0 D(Ø) X 34.0 (L) – BONE MILL BASE

  • ABMC BONE MILL 14.9 D(Ø) X 55.0 (L) – BONE MILL CHISEL

  • ABMG BONE MILL 27.9 D(Ø) X 21.5 (L) – BONE MILL GRINDER

  • ABMH BONE MILL 50.0 D(Ø) X 207.5 (L) – BONE MILL HAMMER

  • ADG DEPTH GAUGE 3.4 D(Ø) X 78.0 X 19.0 (L)

  • AORD O-RING ABUTMENT DRIVER 8.0 D(Ø) X 18.5 (L)

  • ASMEL MOUNT EXTENSION 4.8 D(Ø) X 14.5 (L) - LONGO

  • ASMES MOUNT EXTENSION 4.8 D(Ø) X 20.5 (L) - CURTO

  • ASOW OPEN WRENCH 3.54 D(Ø) X 59.0 (L)

  • ERFM REMOVAL TOOL FOR FIXTURE MOUNT 1.15 D(Ø) X 20.0 (L) - MINI

  • ERFW REMOVAL TOOL FOR FIXTURE MOUNT 2.0 D(Ø) X 20.0 (L) - WIDE

  • ESDRL EXCELLENT SOLID ABUTMENT DRIVER 7.5 D(Ø) X 19.0 (L) - ROUND

  • ESDRS EXCELLENT SOLID ABUTMENT DRIVER 7.5 D(Ø) X 13.0 (L) - ROUND

  • ESDSL EXCELLENT SOLID ABUTMENT DRIVER 5.5 D(Ø) X 18.5 (L) - SQUARE

  • ESDSS EXCELLENT SOLID ABUTMENT DRIVER 5.5 D(Ø) X 12.5 (L) - SQUARE

  • FRDFE FIXTURE WRENCH 10.0 D(Ø) X 100.0 (L)

  • FRSC FINISHING REAMER 10.0 D(Ø)

  • GSMFDE FIXTURE DRIVER 2.34 D(Ø) X 34.1 (L) - TS

  • GSMFDL FIXTURE DRIVER 2.34 D(Ø) X 24.1 (L) - TS

  • GSMFDS FIXTURE DRIVER 2.34 D(Ø) X 17.1 (L) - TS

  • GSRFDE FIXTURE DRIVER 2.83 D(Ø) X 34.1 (L) - TS

  • GSRFDL FIXTURE DRIVER 2.83 D(Ø) X 24.1 (L) - TS

  • GSRFDS FIXTURE DRIVER 2.83 D(Ø) X 17.1 (L) - TS

  • GTHGS TS TISSUE HEIGTH GAUGE 3.0 X 3.5 D(Ø) X 75.0 (L)

  • HRFR REMOVAL TOOL FOR FIXTURE MOUNT 1.5 D(Ø) X 19.6 (L) - REGULAR

  • LWC L-WRENCH 5.3 D(Ø) X 86.0 (L)

  • MJH BONE CARRIER 7.9 D(Ø) X 108 (L) – MULTI JOINT HANDLE

  • MSDS MS DEPTH GAUGE 20.0 D(Ø) X 95.0 (L)

  • MSDS DRIVER SEPARATOR 5.0 D(Ø) X 30.0 (L)

  • MSDTS TORQUE DRIVER FOR DENTURE 5.0 D(Ø) X 13.5 (L)

  • MSPTL TORQUE DRIVER FOR NARROW RIDGE 3.2 D(Ø) X 21.5 (L)

  • OARH ESR HANDLE 7.0 D(Ø) X 107.86 (L)

  • OARTMEL ABUTMENT REMOVAL TIP 2.25 D(Ø) X 34.1 (L) - MINI

  • OARTML ABUTMENT REMOVAL TIP 2.25 D(Ø) X 21.5 (L) - MINI

  • OARTMS ABUTMENT REMOVAL TIP 2.25 D(Ø) X 16.2 (L) - MINI

  • OARTREL ABUTMENT REMOVAL TIP 2.3 D(Ø) X 34.1 (L) - REGULAR

  • OARTRL ABUTMENT REMOVAL TIP 2.6 D(Ø) X 18.5 (L) - REGULAR

  • OARTRS ABUTMENT REMOVAL TIP 2.6 D(Ø) X 13.5 (L) - REGULAR

  • ODG DEPTH GAUGE 1.7 X 3.54 D(Ø) X 66.8 (L)

  • ODRL OCTA ABUTMENT DRIVER 6.9 D(Ø) X 19.4 (L) - ROUND

  • ODRS OCTA ABUTMENT DRIVER 6.9 D(Ø) X 13.4 (L) - ROUND

  • ODSL OCTA ABUTMENT DRIVER 5.0 D(Ø) X 18.5 (L) - SQUARE

  • ODSS OCTA ABUTMENT DRIVER 5.0 D(Ø) X 12.5 (L) - SQUARE

  • OGSRL GUIDE 3.5 D(Ø) X 17.1 (L) - SS, ANODIZING (GREEN)

  • OGSRS GUIDE 3.5 D(Ø) X 17.1 (L) - SS, ANODIZING (GREEN)

  • OGTML GUIDE 3.5 D(Ø) X 20.2 (L) - TS, ANODIZING (GREEN)

  • OGTMS GUIDE 3.5 D(Ø) X 15.2 (L) - TS, ANODIZING (GREEN)

  • OGTRL GUIDE 3.5 D(Ø) X 16.5 (L) - TS, ANODIZING (GREEN)

  • OGTRS GUIDE 3.5 D(Ø) X 11.5 (L) - TS, ANODIZING (GREEN)

  • OGUML GUIDE 3.5 D(Ø) X 17.9 (L) - US, ANODIZING (GREEN)

  • OGUMS GUIDE 3.5 D(Ø) X 12.9 (L) - US, ANODIZING (GREEN)

  • OGURL GUIDE 4.1 D(Ø) X 17.9 (L) - US, ANODIZING (GREEN)

  • OGURS GUIDE 4.1 D(Ø) X 12.9 (L) - US, ANODIZING (GREEN)

  • OGUWL GUIDE 5.0 D(Ø) X 17.9 (L) - US, ANODIZING (GREEN)

  • OGUWS GUIDE 5.0 D(Ø) X 12.9 (L) - US, ANODIZING (GREEN)

  • OMDH MACHINE DRIVE HANDLE 7.0 D(Ø) X 11.0 (L)

  • ORC TORQUE CONNECTOR 8.0 D(Ø) X 10.2 (L) - ROUND

  • ORC TORQUE WRENCH SET 8.0 D(Ø) X 10.2 (L)

  • ORDML RIGID OUTER DRIVER 4.5 D(Ø) X 21.5 (L) – LONGO

  • ORDMS RIGID OUTER DRIVER 4.5 D(Ø) X 16.5 (L) – CURTO

  • ORDRL RIGID OUTER DRIVER 5.5 D(Ø) X 21.5 (L) – LONGO

  • ORDRS RIGID OUTER DRIVER 5.5 D(Ø) X 16.5 (L) – CURTO

  • ORDWL RIGID OUTER DRIVER 6.5 D(Ø) X 21.5 (L) – LONGO

  • ORDWS RIGID OUTER DRIVER 6.5 D(Ø) X 16.5 (L) – CURTO

  • ORTM RE-TAP 2.35 D(Ø) X 31.0 (L)

  • ORTR RE-TAP 2.35 D(Ø) X 28.0 (L)

  • ORVDML REVERSE DRIVER 1.2 D(Ø) X 31.9 (L) – MINI / LONGO

  • ORVDRL REVERSE DRIVER 1.45 D(Ø) X 26.9 (L) – REGULAR / LONGO

  • ORVDRS REVERSE DRIVER 1.45 D(Ø) X 31.9 (L) – REGULAR / CURTO

  • OSDG DEPTH GAUGE 1.7 X 3.54 D(Ø) X 66.8 (L)

  • OTE TORQUE EXTENSION 6.5 D(Ø) X 16.0 (L)

  • SDRL SOLID ABUTMENT DRIVER 4.8 D(Ø) X 19.0 (L) - ROUND

  • SDRS SOLID ABUTMENT DRIVER 4.8 D(Ø) X 13.0 (L) - ROUND

  • SDSL SOLID ABUTMENT DRIVER 5.0 D(Ø) X 18.5 (L) - ROUND

  • SDSS SOLID ABUTMENT DRIVER 5.0 D(Ø) X 12.5 (L) - ROUND

  • SMDG DEFECT GAUGE 29.0 D(Ø) X 85.0 (L)

  • SNDG DEPTH GAUGE 85.0 X 26.0 (L)

  • SSRFDE FIXTURE DRIVER 3.8 D(Ø) X 34.1 (L) - SS

  • SSRFDL FIXTURE DRIVER 3.8 D(Ø) X 24.1 (L) - SS

  • SSRFDS FIXTURE DRIVER 3.8 D(Ø) X 17.1 (L) - SS

  • TASB TRANSFER ABUTMENT SEPARATE BODY 4.0 D(Ø) X 39.39 (L)

  • TASD TRANSFER ABUTMENT SEPARATE DRIVER 1.32 D(Ø) X 18.1 (L)

  • TAST TRANSFER ABUTMENT SEPARATE TOOL TASD + TASB

  • TIDHC DRIVER HANDLE 9.9 D(Ø) X 13.0 (L)

  • TQHD TORQUE HANDLE 3.96 D(Ø) X 139.0 (L)

  • TQWCB TORQUE WRENCH 11.2 D(Ø) X 104.47 (L) - HIOSSEN

  • USMFDL FIXTURE DRIVER 3.5 D(Ø) X 20.5 (L) - US

  • USRFDL FIXTURE DRIVER 4.1 D(Ø) X 20.5 (L) - US

  • USWFDL FIXTURE DRIVER 5.1 D(Ø) X 20.5 (L) - US

Instruções de Uso e Arquivos(1)

Instruções de uso _ Osstem Instrumento 5.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T1734281618/08/2022, 13:58Exp. 4571433221

A atualização destes documentos é executada pela empresa responsável pela regularização do produto.

Documentos Técnicos(1)

447007422104/08/2022

MATERIAL – Notificação de Dispositivo Médico Classe I

Publicado deferimento

Petição primária

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Fonte: Dados Abertos ANVISA + API Oficial ANVISA
Última atualização: 12 de Outubro de 2026
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