BEUDAMED
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    Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008

    FDA Recall
    Terminated ·Straumann USA LLC·Product code OAT·September 28, 2007

    Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008

    FDA Recall
    Terminated ·Straumann USA LLC·Product code OAT·September 28, 2007

    Straumann T-Sleeve 2.8mm, height 6mm, guided Article Number: 034.055V46 Intended for use as a drilling guide to prepare a site for placement of a dental implant into the dental implant site.

    FDA Recall
    Terminated ·Straumann Manufacturing Inc.·Product code NDP·June 4, 2009

    Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.

    FDA Recall
    Terminated ·Straumann USA LLC·Product code NDP·May 27, 2021

    Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810

    FDA Recall
    Terminated ·Straumann Usa, Llc·Product code EGG·January 10, 2008

    Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used

    FDA Recall
    Terminated ·Straumann USA, LLC·Product code DZE·September 24, 2014

    Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.

    FDA Recall
    Terminated ·Straumann USA, LLC·Product code NDP·March 12, 2012

    Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.

    FDA Recall
    Terminated ·Straumann USA, LLC·Product code NDP·October 27, 2014

    Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107

    FDA Recall
    Terminated ·Straumann USA LLC·Product code DZE·November 30, 2021

    Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment in edentulous or partially edentulous patients. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function a Straumann Narrow CrossFit CARES ZrO2 abutment is attached by screw to the dental implant. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.

    FDA Recall
    Terminated ·Straumann USA, LLC·Product code NHA·July 11, 2012

    Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery.

    FDA Recall
    Terminated ·Straumann USA, LLC·Product code DZE·September 19, 2014

    Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089

    FDA Recall
    Terminated ·Straumann USA LLC·Product code DZE·November 30, 2021

    Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107

    FDA Enforcement
    Class II ·Terminated·Straumann USA LLC·January 26, 2022

    Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089

    FDA Enforcement
    Class II ·Terminated·Straumann USA LLC·January 26, 2022

    Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment in edentulous or partially edentulous patients. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function a Straumann Narrow CrossFit CARES ZrO2 abutment is attached by screw to the dental implant. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.

    FDA Enforcement
    Class II ·Terminated·Straumann USA, LLC·August 15, 2012

    Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery.

    FDA Enforcement
    Class II ·Terminated·Straumann USA, LLC·October 29, 2014

    Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.

    FDA Enforcement
    Class II ·Terminated·Straumann USA, LLC·January 21, 2015

    Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Straumann USA LLC·August 11, 2021

    Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used

    FDA Enforcement
    Class II ·Terminated·Straumann USA, LLC·November 12, 2014