Home GUDID 05060483012155 Prosthetic Silicone Materials
Primary DI 05060483012155
Brand Prosthetic Silicone Materials
Company TECHNOVENT LIMITED
Model TechSil 25 – 500g
Catalog number S25(500g)
Device description Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
Published 2024-07-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name GBI Material, External Aesthetic Restoration, Used With Adhesive
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GBI Material, External Aesthetic Restoration, Used With Adhesive General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05060483012155 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05060483012155 05060483012155 5060483012155
GMDN Terms# Term, Definition table Term Definition Dental appliance fabrication material, resin A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date. Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 225835156 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05060483010496 Magnabutments B-MA1-S Mini Magnabutment (Branemark) – S-Range B-MA1-S 2024-10-14 05060483010502 Magnabutments B-MA2-S Maxi Magnabutment (Branemark) – S-Range B-MA2-S 2024-10-14 05060483010519 Magnabutments E-MA1-S Mini Magnabutment (Cochlear Vistafix, hist E-MA1-S 2024-10-14 05060483010526 Magnabutments E-MA2-S Maxi Magnabutment (Cochlear Vistafix, hist E-MA2-S 2024-10-14 05060483010540 Magnabutments S-MA2-S Maxi Magnabutment (Straumann ITI) – S-Rang S-MA2-S 2024-10-14 05060483010601 Magnabutments P-MA1-5.0-S Mini Magnabutment (Medicon, 5.0mm) – S P-MA1-5.0-S 2024-10-14 05060483010625 Magnabutments P-MA2-1.6-S Maxi Magnabutment (Medicon, 1.6mm) – S P-MA2-1.6-S 2024-10-14 05060483010632 Magnabutments P-MA2-3.5-S Maxi Magnabutment (Medicon, 3.5mm) – S P-MA2-3.5-S 2024-10-14 05060483010649 Magnabutments P-MA2-5.0-S Maxi Magnabutment (Medicon, 5.0mm) – S P-MA2-5.0-S 2024-10-14 05060483010656 Magnabutments P-MA2-6.5-S Maxi Magnabutment (Medicon, 6.5mm) – S P-MA2-6.5-S 2024-10-14 05060483010663 Magnabutments IE-MA1-S Mini Magnabutment (Southern Implants) – S IE-MA1-S 2024-10-14 05060483010670 Magnabutments IE-MA2-S Maxi Magnabutment (Southern Implants) – S IE-MA2-S 2024-10-14 05060483010687 Magnabutments IT-MA1-S Mini Magnabutment (Southern Implants) – S IT-MA1-S 2024-10-14 05060483010694 Magnabutments IT-MA2-S Maxi Magnabutment (Southern Implants) – S IT-MA2-S 2024-10-14 05060483010700 Magnabutments HX-MA1-S Mini Magnabutment (Southern Implants) – S HX-MA1-S 2024-10-14 05060483010717 Magnabutments HX-MA2-S Maxi Magnabutment (Southern Implants) – S HX-MA2-S 2024-10-14 05060483010076 Prosthetic Adhesives ProBond Adhesive 37ml G609 2024-07-22 05060483010755 ‘MagnaCap’ Magnetic Retention System Mini Magnacap Astra Uni Abutment S-Range AMC1-S 2024-07-22 05060483010762 ‘MagnaCap’ Magnetic Retention System Maxi Magnacap Astra Uni Abutment S-Range AMC2-S 2024-07-22 05060483010779 ‘MagnaCap’ Magnetic Retention System Mini Magnacap - Lab Analogue B-LAC1 2024-07-22
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