FDAApril 13, 2018device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
The products are labeled with an incorrect product number.
What to do
FDA enforcement status: Terminated
Brands named
coltene whaledentcoltene
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASciCan 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: S100012023-01-20
- FDADental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L7412021-03-18
- FDAAlpen Clinic 100 Carbide Instruments (R100057C)2020-10-20
- FDAClinic Pack 100 Pieces FG 57 100057C (100057C)2020-10-20
- FDAFG 57 100057X (100057X)2020-10-20
- FDACEI Cutting Edge Instruments (PTC-57C)2020-10-20
- FDAStrauss 25 Carbide Dental Burs (100057XXV)2020-10-20
- FDAHYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.2020-06-03
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