FDA-Device2023-03-08Class II
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
Coltene Whaledent Inc
Hazard
Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
Sold states
Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey
Affected count
3896 units
Manufactured in
235 Ascot Pkwy, N/A, Cuyahoga Falls, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1208-2023Don't want to check this manually?
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