BEUDAMED
    93 results · 17ms · Sources: EU EUDAMED, US FDA

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    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

    PREMISE KIT, PART NO. 32612, UNIDOSE PREMISE MASTER KIT, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32814, 10 PACK UNIDOSE PREMISA A3.5 (INTERNATIONAL ONLY), dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32837, 10 PACK UNIDOSE PREMISA TRANSLUCENT AMBER (INTERNATIONAL ONLY), dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32822, 10 PACK UNIDOSE PREMISA C3 (INTERNATIONAL ONLY), dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32672, 10 PACK UNIDOSE PREMISE B1 OPAQUE, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32664, 10 PACK UNIDOSE PREMISE D3, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    37% Etching Gel-1ml syringe 50 pk, part # T06B The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.

    FDA Recall
    Terminated ·Kerr/pentron Dba Kerr Corporation And Pentron Clinical·Product code EBF·March 31, 2011

    Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

    FDA Recall
    Terminated ·Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany·Product code EBF·July 9, 2019

    PREMISE, PART NO. 32666, 10 PACK UNIDOSE PREMISE XL1, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32676, 10 PACK UNIDOSE PREMISE TRANS AMBER, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32669, 10 PACK UNIDOSE PREMISE A3 OPAQUE, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32650, 10 PACK UNIDOSE PREMISE A1, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32824, 10 PACK UNIDOSE PREMISA D2 (INTERNATIONAL ONLY), dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    Flow Tec Nano-Hybrid Flowable Affected Product Syringe Part No. Value Pack Part. No. Shade BEN3784-514 BEN3786-754 A1 BEN3784-532 BEN3786-763 A2 BEN3784-541 BEN3784-738 A3 BEN3784-550 BEN3784-747 A3.5 BEN3784-569 BEN3784-756 A4 BEN3784-578 BEN3784-765 B1 BEN3784-596 BEN3784-774 B2 BEN3784-603 BEN3784-783 C1 BEN3784-612 BEN3784-792 C2 BEN3784-621 BEN3784-809 C3 BEN3784-649 BEN3784-818 D2 BEN3784-722 BEN3784-818 Universal Opaque BEN3784-685 BEN3784-827 A0 BEN3784-701 BEN3784-836 Incisal. The intended use of this device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artiste Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code EBF·March 3, 2011

    Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% filled by volume with 0.7 m average particle size. Dentin Shades: fluorescent properties to replicate natural dentin. Available in 18 dentin shades. Enamel Shades: opalescent properties to replicate enamel. Available in 16 enamel shades including pearl, translucent, and opaque shades. Component: N/A

    FDA Recall
    Open, Classified ·Ultradent Products, Inc.·Product code EBF·August 2, 2024

    PREMISE, PART NO. 32651, 10 PACK UNIDOSE PREMISE A2, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32830, 10 PACK UNIDOSE PREMISA DESTIN A3 (INTERNATIONAL ONLY), dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32661, 10 PACK UNIDOSE PREMISE C3, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32656, 10 PACK UNIDOSE PREMISE B2, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008