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Dispositivos MédicosAtivo

Limas para Motor Denco

82124100002
Informações Gerais

Nome do produto

Limas para Motor Denco

Número de registro

82124100002

Nome técnico

Limas Para Odontologia

Classe de risco

I

Processo

25351325104202370

Empresa Detentora

Razão social

DENTELINE INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS LTDA

CNPJ

25.265.400/0001-50

Fabricante

DENTELINE INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS LTDA

País de fabricação

BRASIL

Registro

Situação

Ativo

Vencimento

Registro vigente

Validade prevista: 05/06/2028

Histórico de Situação
VálidoATIVO07/05/2026

Detectado a cada sincronização diária com a ANVISA.

Apresentações / Modelos(201)

  • D-FILES D1

  • D-FILES D2

  • D-FILES D3

  • D-FILES SORTIDA D1 , D2 , D3

  • D-Shaper BLUE 01/09

  • D-Shaper BLUE 15/02

  • D-Shaper BLUE 15/03

  • D-Shaper BLUE 16/02

  • D-Shaper BLUE 16/03

  • D-Shaper BLUE 17/04

  • D-Shaper BLUE 20/04

  • D-Shaper BLUE 25/04

  • D-Shaper BLUE 25/06

  • D-Shaper BLUE 25/08

  • D-Shaper BLUE 25/09

  • D-Shaper BLUE 30/04

  • D-Shaper BLUE 35/04

  • D-Shaper BLUE 40/04

  • D-Shaper BLUE 50/04

  • D-Shaper BLUE 60/03

  • D-Shaper BLUE 70/03

  • D-Shaper BLUE Assortment Kit 01/09 ( Gold ), 16/02 ( Gold ), 20/04 ( BLUE ), 25/04 ( BLUE ), 30/04 ( BLUE ), 35/04 ( BLUE ).

  • D-Shaper BLUE Assortment Kit 25/08 ( Gold ), 16/02 ( Gold ), 20/04 ( BLUE ), 25/04 ( BLUE ), 30/04 ( BLUE ), 35/04 ( BLUE ).

  • D-Shaper BLUE Assortment Kit 25/09 ( Gold ), 16/02 ( Gold ), 20/04 ( BLUE ), 25/04 ( BLUE ), 30/04 ( BLUE ), 35/04 ( BLUE ).

  • D-Shaper BLUE Assortment Kit 40/04 ( BLUE ), 50/04 ( BLUE ), 60/03 ( Gold ), 70/03 ( BLUE).

  • D-Shaper BLUE Assortment Kit GlidePath 15/03 ( BLUE ), 16/02 ( BLUE ) , 17/04 ( BLUE ).

  • D-Shaper Chameleon 01/09

  • D-Shaper Chameleon 15/02

  • D-Shaper Chameleon 15/03

  • D-Shaper Chameleon 16/02

  • D-Shaper Chameleon 16/03

  • D-Shaper Chameleon 17/04

  • D-Shaper Chameleon 20/04

  • D-Shaper Chameleon 25/04

  • D-Shaper Chameleon 25/06

  • D-Shaper Chameleon 25/08

  • D-Shaper Chameleon 25/09

  • D-Shaper Chameleon 30/04

  • D-Shaper Chameleon 35/04

  • D-Shaper Chameleon 40/04

  • D-Shaper Chameleon 50/04

  • D-Shaper Chameleon 60/03

  • D-Shaper Chameleon 70/03

  • D-Shaper Chameleon Assortment Kit 01/09 ( Chameleon ), 16/02 ( Chameleon ), 20/04 ( Chameleon ), 25/04 ( Chameleon ), 30/04 ( Chameleon ), 35/04 ( Chameleon ).

  • D-Shaper Chameleon Assortment Kit 25/08 ( Chameleon ), 16/02 ( Chameleon ), 20/04 ( Chameleon ), 25/04 ( Chameleon ), 30/04 ( Chameleon ), 35/04 ( Chameleon ).

  • D-Shaper Chameleon Assortment Kit 25/09 ( Chameleon ), 16/02 ( Chameleon ), 20/04 ( Chameleon ), 25/04 ( Chameleon ), 30/04 ( Chameleon ), 35/04 ( Chameleon ).

  • D-Shaper Chameleon Assortment Kit 40/04 ( Chameleon ), 50/04 ( Chameleon ), 60/03 ( Chameleon ), 70/03 ( Chameleon ).

  • D-Shaper Chameleon Assortment Kit GlidePath 15/03 ( Chameleon ), 16/02 ( Chameleon ) , 17/04 ( Chameleon ).

  • D-Shaper Gold 01/09

  • D-Shaper Gold 15/02

  • D-Shaper Gold 15/03

  • D-Shaper Gold 16/02

  • D-Shaper Gold 16/03

  • D-Shaper Gold 17/04

  • D-Shaper Gold 20/04

  • D-Shaper Gold 25/04

  • D-Shaper Gold 25/06

  • D-Shaper Gold 25/08

  • D-Shaper Gold 25/09

  • D-Shaper Gold 30/04

  • D-Shaper Gold 35/04

  • D-Shaper Gold 40/04

  • D-Shaper Gold 50/04

  • D-Shaper Gold 60/03

  • D-Shaper Gold 70/03

  • D-Shaper Gold Assortment Kit 01/09 ( Gold ), 16/02 ( Gold ), 20/04 ( Gold ), 25/04 ( Gold ), 30/04 ( Gold ), 35/04 ( Gold ).

  • D-Shaper Gold Assortment Kit 25/08 ( Gold ), 16/02 ( Gold ), 20/04 ( Gold ), 25/04 ( Gold ), 30/04 ( Gold ), 35/04 ( Gold ).

  • D-Shaper Gold Assortment Kit 25/09 ( Gold ), 16/02 ( Gold ), 20/04 ( Gold ), 25/04 ( Gold ), 30/04 ( Gold ), 35/04 ( Gold ).

  • D-Shaper Gold Assortment Kit 40/04 ( Gold ), 50/04 ( Gold ), 60/03 ( Gold ), 70/03 ( Gold ).

  • D-Shaper Gold Assortment Kit GlidePath 15/03 ( Gold ), 16/02 ( Gold ) , 17/04 ( Gold ).

  • D-SUPER FILES GOLD F1

  • D-SUPER FILES GOLD F2

  • D-SUPER FILES GOLD F3

  • D-SUPER FILES GOLD F4

  • D-SUPER FILES GOLD F5

  • D-SUPER FILES GOLD S1

  • D-SUPER FILES GOLD S2

  • D-SUPER FILES GOLD Sortida Sx , S1 , S2 , F1 , F2 , F3

  • D-SUPER FILES GOLD Sx

  • Dual Shaper 16

  • Dual Shaper 20/04

  • Dual Shaper 25/04

  • Dual Shaper 25/06

  • Dual Shaper Sortida SX , 16 , 20/04 , 25/04 , 25/06

  • Dual Shaper SX

  • Kids Files 25/04

  • Kids Files 25/06

  • Kids Files 30/04

  • Kids Files 40/04

  • Kids Files Sortida 25/04 , 25/06 , 30/04 , 40/04

  • Only one files Blue R25/08

  • Only one files Blue R40/06

  • Only one files Blue R50/05

  • Only one files Blue Sortida R25 ( Blue ), R40 ( Blue ), R50 ( Blue )

  • Only one files Collors R25/08

  • Only one files Collors R40/06

  • Only one files Collors R50/05

  • Only one files Collors Sortida R25 ( Blue ), R40 ( Blue ), R50 ( Blue )

  • Only one files Gold R25/08

  • Only one files Gold R40/06

  • Only one files Gold R50/05

  • Only one files Gold Sortida R25 ( Gold ), R40 ( Gold ), R50 ( Gold )

  • Only one files R25/08

  • Only one files R40/06

  • Only one files R50/05

  • Only one files Sortida - R25, R40, R50

  • Proflexi Files BLUE 01/09

  • Proflexi Files BLUE 15/02

  • Proflexi Files BLUE 15/03

  • Proflexi Files BLUE 16/02

  • Proflexi Files BLUE 16/03

  • Proflexi Files BLUE 17/04

  • Proflexi Files BLUE 20/04

  • Proflexi Files BLUE 25/04

  • Proflexi Files BLUE 25/06

  • Proflexi Files BLUE 25/08

  • Proflexi Files BLUE 25/09

  • Proflexi Files BLUE 30/04

  • Proflexi Files BLUE 35/04

  • Proflexi Files BLUE 40/04

  • Proflexi Files BLUE 50/04

  • Proflexi Files BLUE 60/03

  • Proflexi Files BLUE 70/03

  • Proflexi Files BLUE Assortment Kit 01/09 ( Gold ), 16/02 ( Gold ), 20/04 ( BLUE ), 25/04 ( BLUE ), 30/04 ( BLUE ), 35/04 ( BLUE ).

  • Proflexi Files BLUE Assortment Kit 25/08 ( Gold ), 16/02 ( Gold ), 20/04 ( BLUE ), 25/04 ( BLUE ), 30/04 ( BLUE ), 35/04 ( BLUE ).

  • Proflexi Files BLUE Assortment Kit 25/09 ( Gold ), 16/02 ( Gold ), 20/04 ( BLUE ), 25/04 ( BLUE ), 30/04 ( BLUE ), 35/04 ( BLUE ).

  • Proflexi Files BLUE Assortment Kit 40/04 ( BLUE ), 50/04 ( BLUE ), 60/03 ( Gold ), 70/03 ( BLUE).

  • Proflexi Files BLUE Assortment Kit GlidePath 15/03 ( BLUE ), 16/02 ( BLUE ) , 17/04 ( BLUE ).

  • PROFLEXI files Chameleon 01/09

  • PROFLEXI files Chameleon 15/02

  • PROFLEXI files Chameleon 15/03

  • PROFLEXI files Chameleon 16/02

  • PROFLEXI files Chameleon 16/03

  • PROFLEXI files Chameleon 17/04

  • PROFLEXI files Chameleon 20/04

  • PROFLEXI files Chameleon 25/04

  • PROFLEXI files Chameleon 25/06

  • PROFLEXI files Chameleon 25/08

  • PROFLEXI files Chameleon 25/09

  • PROFLEXI files Chameleon 30/04

  • PROFLEXI files Chameleon 35/04

  • PROFLEXI files Chameleon 40/04

  • PROFLEXI files Chameleon 50/04

  • PROFLEXI files Chameleon 60/03

  • PROFLEXI files Chameleon 70/03

  • PROFLEXI files Chameleon Assortment Kit 01/09 ( Collors ), 16/02 ( Collors ), 20/04 ( Collors ), 25/04 ( Collors ), 30/04 ( Collors ), 35/04 ( Collors ).

  • PROFLEXI files Chameleon Assortment Kit 25/08 ( Collors ), 16/02 ( Collors ), 20/04 ( Collors ), 25/04 ( Collors ), 30/04 ( Collors ), 35/04 ( Collors ).

  • PROFLEXI files Chameleon Assortment Kit 25/09 ( Collors ), 16/02 ( Collors ), 20/04 ( Collors ), 25/04 ( Collors ), 30/04 ( Collors ), 35/04 ( Collors ).

  • PROFLEXI files Chameleon Assortment Kit 40/04 ( Collors ), 50/04 ( Collors ), 60/03 ( Collors ), 70/03 ( Collors ).

  • PROFLEXI files Chameleon Assortment Kit GlidePath 15/03 ( Collors ), 16/02 ( Collors ) , 17/04 ( Collors ).

  • Proflexi Files Gold 01/09

  • Proflexi Files Gold 15/02

  • Proflexi Files Gold 15/03

  • Proflexi Files Gold 16/02

  • Proflexi Files Gold 16/03

  • Proflexi Files Gold 17/04

  • Proflexi Files Gold 20/04

  • Proflexi Files Gold 25/04

  • Proflexi Files Gold 25/06

  • Proflexi Files Gold 25/08

  • Proflexi Files Gold 25/09

  • Proflexi Files Gold 30/04

  • Proflexi Files Gold 35/04

  • Proflexi Files Gold 40/04

  • Proflexi Files Gold 50/04

  • Proflexi Files Gold 60/03

  • Proflexi Files Gold 70/03

  • Proflexi Files Gold Assortment Kit 01/09 ( Gold ), 16/02 ( Gold ), 20/04 ( Gold ), 25/04 ( Gold ), 30/04 ( Gold ), 35/04 ( Gold ).

  • Proflexi Files Gold Assortment Kit 25/08 ( Gold ), 16/02 ( Gold ), 20/04 ( Gold ), 25/04 ( Gold ), 30/04 ( Gold ), 35/04 ( Gold ).

  • Proflexi Files Gold Assortment Kit 25/09 ( Gold ), 16/02 ( Gold ), 20/04 ( Gold ), 25/04 ( Gold ), 30/04 ( Gold ), 35/04 ( Gold ).

  • Proflexi Files Gold Assortment Kit 40/04 ( Gold ), 50/04 ( Gold ), 60/03 ( Gold ), 70/03 ( Gold ).

  • Proflexi Files Gold Assortment Kit GlidePath 15/03 ( Gold ), 16/02 ( Gold ) , 17/04 ( Gold ).

  • Roll Wave Gold Large 45/05

  • Roll Wave Gold Medium 35/06

  • Roll Wave Gold Primary 25/07

  • Roll Wave Gold Small 20/07

  • Roll Wave Gold SPML Assortmet 20/07 , 25/07 , 35/06 , 45/05

  • SuperFiles F1

  • SuperFiles F2

  • SuperFiles F3

  • SuperFiles F4

  • SuperFiles F5

  • SuperFiles II Gold Sortida X1 , X2 , X3

  • SuperFiles II Gold X1

  • SuperFiles II Gold X2

  • SuperFiles II Gold X3

  • SuperFiles II Gold X4

  • SuperFiles II Gold X5

  • Superfiles III BLUE F2

  • Superfiles III BLUE F3

  • Superfiles III BLUE F4

  • Superfiles III BLUE F5

  • Superfiles III BLUE S1

  • Superfiles III BLUE S2

  • Superfiles III BLUE Sortida Sx , S1 , S2 , F1 , F2 , F3

  • Superfiles III BLUE Sx

  • Superfiles III BLUEF1

  • SuperFiles S1

  • SuperFiles S2

  • SuperFiles Sortida Sx , S1 , S2 , F1 , F2 , F3

  • SuperFiles Sx

Instruções de Uso e Arquivos(1)

IFU - Limas Para Motor Denco - rev00.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T2008468614/06/2023, 20:42Exp. 0604861231

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

Documentos Técnicos(1)

052452523405/06/2023

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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