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INION BIORESTORE™ SUSTITUTO DE INJERTO ÓSEO SINTÉTICO - INVIMA Registration 4ed7e23b54adda1a4d87aab598715493

Access comprehensive regulatory information for INION BIORESTORE™ SUSTITUTO DE INJERTO ÓSEO SINTÉTICO (INION BIORESTORE™ SYNTHETIC BONE GRAFT SUBSTITUTE) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID 4ed7e23b54adda1a4d87aab598715493 and manufactured by LH S.A.S.. The device was registered on March 08, 2034.

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

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INVIMA Official Data
III
4ed7e23b54adda1a4d87aab598715493
INION BIORESTORE™ SUSTITUTO DE INJERTO ÓSEO SINTÉTICO
INVIMA Analysis ID: 4ed7e23b54adda1a4d87aab598715493
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Product Use / Uso del Producto
Spanish

LOS IMPLANTES INION BIORESTORE™ SON SUSTITUTOS DE INJERTOS ÓSEOS SINTÉTICOS INDICADOS PARA APLICACIÓN EN VACÍOS Y CAVIDADES ÓSEAS NO INTRÍNSECAS DE LA ESTABILIDAD DE LA ESTRUCTURA ÓSEA, SE INTRODUCEN EN VACÍOS Y CAVIDADES ÓSEAS DEL SISTEMA ESQUELÉTICO PARA RELLENAR Y/O AUMENTAR DEFECTOS INTRAÓSEOS DENTALES, ORALES Y MAXILOFACIALES, ASÍ COMO DEFECTOS EN LAS EXTREMIDADES, LA COLUMNA Y LA PELVIS. ESTOS DEFECTOS ÓSEOS PUEDEN SER CONSECUENCIA DE UNA ACCIÓN QUIRÚRGICA O DE UNA LESIÓN TRAUMÁTICA DEL HUESO, POR EJEMPLO: DEFECTOS INFRAÓSEOS PERIODONTALES; AUMENTO DEL BORDE ALVEOLAR (SINUSOTOMÍA, OSTEOTOMÍA O QUISTECTOMÍA); ALVEOLOS DE EXTRACCIÓN DENTARIA (MANTENIMIENTO DEL BORDE O PREPARACIÓN Y COLOCACIÓN DEL IMPLANTE); ELEVACIÓN DE SENOS MAXILARES; DEFECTOS QUÍSTICOS; Y RECONSTRUCCIÓN CRANEOFACIAL. _x000D_ _x000D_ _x000D_

English

INION BIORESTORE™ IMPLANTS ARE SYNTHETIC BONE GRAFT SUBSTITUTES INDICATED FOR APPLICATION IN VOIDS AND NON-INTRINSIC BONE CAVITIES OF BONE STRUCTURE STABILITY, THEY ARE INTRODUCED INTO VOIDS AND BONE CAVITIES OF THE SKELETAL SYSTEM TO FILL AND/OR AUGMENT INTRAOSSEOUS DENTAL, ORAL AND MAXILLOFACIAL DEFECTS, AS WELL AS DEFECTS IN THE EXTREMITIES, SPINE AND PELVIS. THESE BONE DEFECTS CAN BE THE RESULT OF A SURGICAL ACTION OR A TRAUMATIC INJURY TO THE BONE, FOR EXAMPLE: PERIODONTAL INFRAOSSEOUS DEFECTS; AUGMENTATION OF THE ALVEOLAR BORDER (SINUSOTOMY, OSTEOTOMY, OR CYSTECTOMY); TOOTH EXTRACTION SOCKETS (MAINTENANCE OF THE EDGE OR PREPARATION AND PLACEMENT OF THE IMPLANT); MAXILLARY SINUS LIFT; CYSTIC DEFECTS; AND CRANIOFACIAL RECONSTRUCTION. _x000D_ _x000D_ _x000D_

Device Classification
Risk Class / Clase de Riesgo
III
Product Type (Spanish)
MEDICO QUIRURGICOS
Product Type (English)
SURGICAL DOCTOR
Registration Information
Analysis ID
4ed7e23b54adda1a4d87aab598715493
Expire Date
March 08, 2034
Authorized Company / Fabricante
Name (Spanish)
LH S.A.S.
Name (English)
LH S.A.S.