FDA-Device2020-11-25Class II
FG 57 100057X (100057X)
Coltene Whaledent Inc
Hazard
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Sold states
Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Affected count
556
Manufactured in
235 Ascot Pkwy, N/A, Cuyahoga Falls, OH, United States
Products
FG 57 100057X (100057X)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0465-2021Don't want to check this manually?
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