FDA-Device2014-08-06Class II
Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.
Novocol, Inc.
Hazard
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
Sold states
Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
Affected count
24
Manufactured in
416 S Taylor Ave, Louisville, CO, United States
Products
Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2129-2014Don't want to check this manually?
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