BEUDAMED
    167 results · 37ms · Sources: EU EUDAMED, US FDA

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    Dental Foil

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Shanghai Coherz Technologies Co., Ltd.·8 devices

    Dental Foil

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Shanghai Coherz Technologies Co., Ltd.·98 devices

    MCRYL UD 18IN 6-0 S/A P-1 PRM

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAN·November 18, 2019

    3003637274-2016-00010

    FDA Adverse Event
    Malfunction ·February 19, 2016

    3M ESPE RETRACTION CAPSULE

    FDA Adverse Event
    3M DEUTSCHLAND GMBH·Product code MVL·July 24, 2014

    Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023

    TRANSLUX 2WAVE

    FDA Adverse Event
    Injury ·KULZER GMBH·Product code EBZ·January 8, 2020

    TRANSLUX

    FDA Adverse Event
    Injury ·KULZER GMBH - HQ·Product code EBZ·January 15, 2020

    Product names: a) Alginate Dental Impression Material Regular Set, Cinnamon Flavor, Pink Color b) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color c) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color, Dustless d) Alginate Dental Impression Material Regular Set, Cherry Flavor, No color e) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color f) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color, Dustless g) Alginate Dental Impression Material Fast Set, Cherry Flavor, No color All are varieties of alginate dental impression powder packaged in aluminum foil pouches labeled as containing approximately 454 grams (one pound), or in the case of one foreign account, packaged in unlabeled 25 lb. and 39 lb. bulk containers. The alginate impression material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient''s teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. This product was cleared as a prescription device; however, it is not labeled as such.

    FDA Recall
    Terminated ·Rite-Dent Manufacturing Corp.·Product code EHY·September 21, 2005

    Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.

    FDA Enforcement
    Class II ·Terminated·Ivoclar A. G.·November 11, 2015

    Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFX·November 17, 2022

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAN·April 1, 2016

    Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.

    FDA Recall
    Terminated ·Ivoclar A. G. Fl-9494 Schaan Liechtenstein·Product code EBC·October 7, 2015

    VICRYL RAP UND 75CM M1.5 USP4/0 SGLE ARMED PC-3 PRIME

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAM·March 1, 2024

    CREST ORAL DISCLOSING TABLETS

    FDA Adverse Event
    Malfunction ·YOUNG DENTAL MANUFACTURING·Product code LFC·March 18, 2009

    MONOCRYL VIO 27IN USP5-0::S/A BB PLUS VB

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAN·November 1, 2018

    MCRYL VIO 18IN 5-0 S/A P-3 PRM MP

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAN·May 17, 2018

    MONOCRYL SUTURE 27"(70CM) 5-0 VIO

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAN·January 25, 2021

    MONOCRYL POLIGLECAPRONE 25 SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAN·July 9, 2018

    MCRYL VIO 18IN 4-0 S/A P-3 PRM MP

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAN·May 17, 2018