5 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.
FDA Recall
Terminated
·Talladium Inc·Product code EIH·August 6, 2020
Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional.
FDA Recall
Terminated
·Talladium Inc·Product code EBG·October 9, 2020
ORAcollect RNA: ORE-100
FDA Recall
Open, Classified
·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code QJR·February 18, 2022
PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.
FDA Recall
Terminated
·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code PPM·June 24, 2020
ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025
FDA Recall
Open, Classified
·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code OYJ·February 18, 2022