BEUDAMED
    54 results · 69ms · Sources: EU EUDAMED, US FDA

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    ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·October 9, 2019

    Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code NDP·May 29, 2018

    REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·May 18, 2018

    The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·March 4, 2016

    ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·October 9, 2019

    ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·October 10, 2017

    Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·August 9, 2019

    ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·August 8, 2018

    ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·August 7, 2018

    The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·April 6, 2016

    RePlant Angled Abutment Part Number 6050-52-60

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·July 5, 2016

    Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·May 2, 2017

    DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·December 16, 2015

    Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code NDP·September 6, 2018

    DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code NHA·October 28, 2015

    Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing LLC·Product code DZE·October 11, 2019

    SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing LLC·Product code NHA·January 9, 2019

    Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·October 26, 2018

    SwishPlus Implant Intended for use in support for fixed bridgework.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code NHA·January 19, 2018

    SwishTapered Implant Intended for use in support for fixed bridgework.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·January 19, 2018