FDA-Device2023-09-20Class II
Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526
Keystone Industries
Hazard
A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.
Affected count
337 units
Manufactured in
480 S Democrat Rd, Gibbstown, NJ, United States
Products
Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2579-2023Don't want to check this manually?
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