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SMILEDIRECTCLUB ALIGNERS ANDRETAINERS SYSTEM - COFEPRIS Registration 139C2021 SSA

Access comprehensive regulatory information for SMILEDIRECTCLUB ALIGNERS ANDRETAINERS SYSTEM (SMILEDIRECTCLUB ALIGNERS ANDRETAINERS SYSTEM) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 139C2021 SSA and manufactured by EMERGO,S.DER.L.DEC.V.. The device was registered on February 05, 2021.

This page provides complete registration details including product type (IV. DENTAL SUPPLIES), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.

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COFEPRIS Official Data
Clase II
139C2021 SSA
SMILEDIRECTCLUB ALIGNERS ANDRETAINERS SYSTEM
COFEPRIS Analysis ID: 139C2021 SSA
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Product Use / Uso del Producto
Spanish

CONSISTE EN UNA SERIE DE APARATOS DEORTODONCIA(ALINEADORES)EXTRAÍBLESDEPLÁSTICO TRANSPARENTE, PRESCRITOS PORUN ODONTÓLOGO. LOS ALINEADORESMUEVEN SUAVEMENTE LOS DIENTES DELPACIENTE EN PEQUEÑOS INCREMENTOSDESDESUESTADOORIGINALAUNESTADOMÁS ÓPTIMO Y TRATADO. EL RETENEDORCONSISTEENUNAPARATODEORTODONCIAREMOVIBLE DE PLÁSTICO TRANSPARENTE,PRESCRITOS POR UN ODONTÓLOGO, QUEESTÁ DISEÑADO PARA MANTENER LOSDIENTES EN POSICIÓN DESPUÉS DE LAALINEACIÓN.

English

IT CONSISTS OF A SERIES OF REMOVABLE TRANSPARENT PLASTIC ORTHODONTIC APPLIANCES (ALIGNERS), PRESCRIBED BY A DENTIST. THE ALIGNERS GENTLY MOVE THE PATIENT'S TEETH IN SMALL INCREMENTS FROM THEIR ORIGINAL STATE TO A MORE OPTIMAL AND TREATED STATE. THE RETAINER CONSISTS OF A REMOVABLE CLEAR PLASTIC ORTHODONTIC APPLIANCE, PRESCRIBED BY A DENTIST, WHICH IS DESIGNED TO HOLD THE TEETH IN POSITION AFTER ALIGNMENT.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
IV. INSUMOS DE USO ODONTOLÓGICO
Product Type (English)
IV. DENTAL SUPPLIES
Trade Name (Spanish)
ALINEADORORTODÓNCICOYRETENEDORPARA ORTODONCIA
Trade Name (English)
ALIGNANTORTHODONTICOR retainerfor ORTHODONTICS
Registration Information
Analysis ID
139C2021 SSA
Registration Date
February 05, 2021
Manufacturer / Fabricante
Name (Spanish)
EMERGO,S.DER.L.DEC.V.
Name (English)
EMERGO,S.DER. L.DEC.V.