BEUDAMED
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    Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy + Light; catalog number 66009583.

    FDA Recall
    Terminated ·Heraeus Kulzer Inc.·Product code ELW·November 1, 2003

    3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for making precise crown and bridge, inlay, onlay, veneer preparations, removable denture and partial denture impressions.

    FDA Recall
    Terminated ·3M Company Health Care Business 3M Center·Product code ELW·November 21, 2013

    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

    The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.

    FDA Recall
    Terminated ·Kerr Corporation·Product code ELW·February 21, 2012

    Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code ELW·February 4, 2013

    Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code ELW·February 4, 2013

    Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584.

    FDA Recall
    Terminated ·Heraeus Kulzer Inc.·Product code ELW·November 1, 2003

    Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912

    FDA Recall
    Terminated ·Clinician's Choice Dental Products Inc.·Product code ELW·March 18, 2022

    Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase; catalog number 66009582.

    FDA Recall
    Terminated ·Heraeus Kulzer Inc.·Product code ELW·November 1, 2003

    Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code ELW·November 9, 2016

    Bosworth Superbite Zinc Oxide Eugenol Bite Registration Paste Kit; the kit consists of one 3.25 oz. tube of Accelerator - Blue, and one 7.5 oz. tube of Base - White, which are mixed as needed to make the registration paste; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; catalog 0921815

    FDA Recall
    Terminated ·Harry J Bosworth Company·Product code ELW·October 13, 2004

    Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code ELW·November 9, 2016

    Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585.

    FDA Recall
    Terminated ·Heraeus Kulzer Inc.·Product code ELW·November 1, 2003

    Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code ELW·November 9, 2016

    Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 2, 2013

    Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 13, 2013

    Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 6, 2013

    Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. The Extended Brilliance Workplace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The EBW is also provided as a component of PET/CT and SPECT/CT systems, performing the same function as indicated above (also referred to as the NM EBW).

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·October 3, 2009

    Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.

    FDA Enforcement
    Class II ·Terminated·Owen Mumford USA, Inc.·April 8, 2015

    Uni-CP Compression Forceps (spreader); Non-sterile, R only, Catalog number: 339001ND Newdeal, Lyon, France; Integra, 411 Enterprise Drive, Plainsboro, NJ 08536 Intended to open the UNI-Compression Plate olive, which creates a compression.

    FDA Recall
    Terminated ·Integra LifeSciences Corp·Product code HRS·September 30, 2008