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SMILEDIRECTCLUB IMPRESSION KIT - COFEPRIS Registration 1284C2021 SSA

Access comprehensive regulatory information for SMILEDIRECTCLUB IMPRESSION KIT (SMILEDIRECTCLUB IMPRESSION KIT) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1284C2021 SSA and manufactured by EMERGO,S.DER.L.DEC.V.. The device was registered on August 19, 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 I
1284C2021 SSA
SMILEDIRECTCLUB IMPRESSION KIT
COFEPRIS Analysis ID: 1284C2021 SSA
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Product Use / Uso del Producto
Spanish

ELKITDEIMPRESIÓNSMILEDIRECTCLUBESTÁDISEÑADO PARA REPRODUCIR LAESTRUCTURADELOSDIENTESYLASENCÍASDE UN PACIENTE QUE FINALMENTE SEUTILIZARÁ PARA PROPORCIONAR MODELOSPARA PRODUCIR ALINEADORES DEORTODONCIA.

English

THE SMILEDIRECTCLUB PRINTING KIT IS DESIGNED TO REPRODUCE THE STRUCTURE OF A PATIENT'S TEETH AND GUMS WHICH WILL ULTIMATELY BE USED TO PROVIDE MODELS FOR PRODUCING ORTHODONTIC ALIGNERS.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
IV. INSUMOS DE USO ODONTOLÓGICO
Product Type (English)
IV. DENTAL SUPPLIES
Trade Name (Spanish)
KIT DEMATERIAL DE IMPRESIÓN DENTAL,REUTILIZABLE.
Trade Name (English)
KIT OF DENTAL IMPRESSION MATERIAL, REUSABLE.
Registration Information
Analysis ID
1284C2021 SSA
Registration Date
August 19, 2021
Manufacturer / Fabricante
Name (Spanish)
EMERGO,S.DER.L.DEC.V.
Name (English)
EMERGO,S.DER. L.DEC.V.