11 results
·
125ms
·
Sources: EU EUDAMED, US FDA
PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013
FDA 510(k)
FDA Class 2
·Dental
ELITE ZIRCONIA HEAD 28MM STD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code JDI·June 6, 2002
Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.*** Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·August 26, 2013
3I INCISE ZR 6 UNIT FRAMEWORK SHADE 0
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code ELZ·March 12, 2015
BELLATEK® ZIRCONIA ABUTMENT
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·November 5, 2014
DO NOT USE-3I INCISE ZR COPING SHADE 2
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·August 2, 2017
PROCERA BRIDGE ZIRCONIA 4 UNIT MEDIUM
FDA Adverse Event
Malfunction
·NOBEL BIOCARE·Product code NSN·July 19, 2017
SOLERO
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code NEY·December 27, 2024
CERCON BASE DISK WHITE 20 MM
FDA Adverse Event
Injury
·DENTSPLY PROSTHETICS·Product code EIH·October 21, 2016
3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 11.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·October 28, 2014
PERCUTANEOUS CATHETER INSERTION TRAY WITH 8 FRENCH INTRODUCER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DQY·September 30, 2009