FDAOctober 20, 2020device
CEI Cutting Edge Instruments (PTC-57C)
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
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
- FDAStrauss 25 Carbide Dental Burs (100057XXV)2020-10-20
- FDAHYGENIC Dental Dam Forceps, Model no. H01262 - 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
- 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
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →