14 results
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56ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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FG 57 100057X (100057X)
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EJL·October 20, 2020
Alpen Clinic 100 Carbide Instruments (R100057C)
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EJL·October 20, 2020
Clinic Pack 100 Pieces FG 57 100057C (100057C)
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EJL·October 20, 2020
Strauss 25 Carbide Dental Burs (100057XXV)
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EJL·October 20, 2020
CEI Cutting Edge Instruments (PTC-57C)
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EJL·October 20, 2020
ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation.
FDA Recall
Terminated
·Coltene Whaledent Inc·Product code ELR·August 21, 2018
HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EJG·June 3, 2020
HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EJG·June 3, 2020
HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EJG·June 3, 2020
HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EJG·June 3, 2020
Latex Dental Dams labeled as Non-Latex Dental Dams
FDA Recall
Terminated
·Coltene Whaledent Inc·Product code EIE·December 11, 2013
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
FDA Recall
Terminated
·Coltene Whaledent Inc·Product code EJL·April 13, 2018
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EFB·January 20, 2023
Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741
FDA Recall
Open, Classified
·Coltene Whaledent Inc·Product code EBL·March 18, 2021