FDA-Device2020-07-01Class II
HYGENIC Wingless Fiesta Kit, Model no. H02790 - 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.
Coltene Whaledent Inc
Hazard
Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Sold states
Pending
Affected count
7,206 forceps
Manufactured in
235 Ascot Pkwy, N/A, Cuyahoga Falls, OH, United States
Products
HYGENIC Wingless Fiesta Kit, Model no. H02790 - 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2422-2020Don't want to check this manually?
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