Coltene Whaledent Inc

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Known Names

coltene whaledent, coltene /whaledent

Recent Recalls

NumberClassProductDate
Z-1208-2023Class IISciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing harJanuary 20, 2023
Z-1494-2021Class IIDental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for labMarch 18, 2021
Z-0466-2021Class IIClinic Pack 100 Pieces FG 57 100057C (100057C)October 20, 2020
Z-0468-2021Class IIStrauss 25 Carbide Dental Burs (100057XXV)October 20, 2020
Z-0464-2021Class IIAlpen Clinic 100 Carbide Instruments (R100057C)October 20, 2020
Z-0467-2021Class IICEI Cutting Edge Instruments (PTC-57C)October 20, 2020
Z-0465-2021Class IIFG 57 100057X (100057X)October 20, 2020
Z-2420-2020Class IIHYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to bJune 3, 2020
Z-2422-2020Class IIHYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended tJune 3, 2020
Z-2419-2020Class IIHYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended toJune 3, 2020
Z-2421-2020Class IIHYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to June 3, 2020
Z-0376-2019Class IIParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B DeAugust 21, 2018
Z-1883-2018Class IIAlpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cuttinApril 13, 2018
Z-2151-2014Class IILatex Dental Dams labeled as Non-Latex Dental DamsDecember 11, 2013