FDA-Device2014-08-06Class II

Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 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
60
Manufactured in
416 S Taylor Ave, Louisville, CO, United States
Products
Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2128-2014

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