6 results
·
42ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
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
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
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 Enforcement
Class II
·Terminated·Coltene Whaledent Inc·May 23, 2018
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 Enforcement
Class II
·Terminated·Coltene Whaledent Inc·November 14, 2018
Latex Dental Dams labeled as Non-Latex Dental Dams
FDA Enforcement
Class II
·Terminated·Coltene Whaledent Inc·August 13, 2014