BEUDAMED
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    WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; WAXING COPING, CONT, 6.5MM,ANG, REF ZOCWAX6A; WAXING COPING, CONT, 6.5MM, REF ZOCWAX6S

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code NDP·July 10, 2017

    WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; WAXING COPING, CONT, 6.5MM,ANG, REF ZOCWAX6A; WAXING COPING, CONT, 6.5MM, REF ZOCWAX6S

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·October 4, 2017

    Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments.

    FDA Recall
    Terminated ·Philips North America, LLC·Product code MKJ·January 14, 2020

    ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code DZE·July 10, 2017

    "***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental Framework***Biomet 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 800-342-5454 www.biomet3i.com Please consult instructions for use and recommendation***For Dental Lab use ONLY Non-sterile/For single Use***" Indicated for use in restorative procedure to affix the final prosthesis to the abutment. Coping and frameworks provide the base structure for final porcelain application as the final step of creating a restoration. The devices are intended to be used to create final restoration for dental reconstruction with either a prepared tooth or dental implant abutment.

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NSP·December 1, 2010

    Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 4, 2020

    ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·October 4, 2017

    Index Coping Surgical Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Provide Impression Coping Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Locator Abutment Impression Coping Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Standard Abutment Transfer Coping Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Certain Pick-up Coping Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Pick-Up Impression Coping Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code DZE·November 25, 2015

    IOL Transfer Impression Coping Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Implant Twist Lock TM Coping Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Certain Twist Lock TM Coping Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Conical Abutment Pick-up Coping Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    IOL Pick-Up Impression Coping Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Certain EP Pick-Up Coping Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Certain Straight Pick Up Coping Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015