7 results
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60ms
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Sources: EU EUDAMED, US FDA
ARANZ Medical Limited
Manufacturer
🇳🇿 New Zealand·1 Basic UDI-DI·1 Device
SilhouetteStar
FDA UDI
ARANZ MEDICAL LIMITED·09420071400010·SilhouetteStar™ is a non-contact device used to...
Silhouette
Device
EU MDR
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Eu Md Class 1
·ARANZ Medical Limited·On the market·3 countries
Silhouette
Basic UDI-DI
EU MDR
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Eu Md Class 1
·ARANZ Medical Limited·1 device
mdi Europa GmbH
Authorized representative
🇩🇪 Germany·132 Manufacturers·4741 Devices
Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle distribution. Component: N/A
FDA Recall
Open, Classified
·Ultradent Products, Inc.·Product code EBF·August 2, 2024
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle distribution. Component: N/A
FDA Recall
Open, Classified
·Ultradent Products, Inc.·Product code EBF·August 2, 2024