FDA-Device2018-05-23Class II
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
Coltene Whaledent Inc
Hazard
The products are labeled with an incorrect product number.
Sold states
The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada
Affected count
11
Manufactured in
235 Ascot Pkwy, Cuyahoga Falls, OH, United States
Products
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1883-2018Don't want to check this manually?
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