BEUDAMED
    26 results · 35ms · Sources: EU EUDAMED, US FDA

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    Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code EBF·February 23, 2009

    Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also OmniChek 1.5% and OmniCheck 1.8%

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code JOJ·February 25, 2003

    Neos Vanadium Excavator Part Number 591/0 SCHE

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code EKC·November 14, 2008

    AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code DYJ·June 6, 2013

    Neos Vanadium Excavator Part Number 591/0-6

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code EKC·November 14, 2008

    Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA. Intended as a root canal filling material that is used in conjunction with gutta percha or silver endodontic points.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code KIF·February 23, 2009

    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

    Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code ELW·November 4, 2010

    Artiste Flowable Part Number N28A, Syringe Lot Number 165741 The intended use of the 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 Artist 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·October 22, 2010

    Neos Vanadium Excavator Part Number 591/3 SCHE

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code EKC·November 14, 2008

    Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code KLE·August 24, 2009

    Neos Vanadium Excavator Part Number 591/4

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code EKC·November 14, 2008

    Neos Vanadium Excavator Part Number 591/5 SCHE

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code EKC·November 14, 2008

    Artiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No Shade N28A N28VA A1 N28B N28VB A2 N28C N28VC A3 N28D N28VD A3.5 N28E N28VE A4 N28F N28VF B1 N28G N28VG B2 N28J N28VJ C1 N28K N28VK C2 N28L N28VL C3 N28N N28VP D2 N28R N28VR Universal Opaque N28XA N28VXA A0 N28XC N28VXC 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

    Flow Tec Part Number 3786-754, Syringe Lot Number 165741 The intended use of the 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 Artist 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·October 22, 2010

    Neos Vanadium Excavator Part Number 591/2

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code EKC·November 14, 2008

    Artiste Flowable Value Pack Part Number N28VA, Syringe Lot Number 165741 The intended use of the 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 Artist 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·October 22, 2010

    Flow Tec Part Number 3784-514, Syringe Lot Number 165741 The intended use of the 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 Artist 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·October 22, 2010

    Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code MMP·February 11, 2015

    Neos Vanadium Excavator Part Number 591/0

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code EKC·November 14, 2008