Coltene Whaledent Inc FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cClass IIJan 20, 2023Screw connection between the turbine head and the push butto	Screw connection between the turbine head and the push button may loosen and fall off during the treatment, an	Class IIDevices	Jan 20, 2023
Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restClass IIMar 18, 2021The incorrect dental pins were packaged and subsequently dis	The incorrect dental pins were packaged and subsequently distributed.	Class IIDevices	Mar 18, 2021