FDA-Device2020-11-25Class II
Clinic Pack 100 Pieces FG 57 100057C (100057C)
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
Clinic Pack 100 Pieces FG 57 100057C (100057C)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0466-2021Don't want to check this manually?
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