4 results
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29ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.
FDA Recall
Terminated
·Heraeus Kulzer, LLC.·Product code KZP·February 10, 2014
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.
FDA Recall
Terminated
·Heraeus Kulzer, LLC.·Product code LBH·April 23, 2014
BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.
FDA Enforcement
Class II
·Terminated·Heraeus Kulzer, LLC.·March 12, 2014
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.
FDA Enforcement
Class II
·Terminated·Heraeus Kulzer, LLC.·May 28, 2014