Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-2579-2023

U.S. FDA — Device Enforcement · United States · 2023-07-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2579-2023
Date of alert: 2023-07-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Keystone Industries
Product category: device
Product type: Devices

Reported risk: A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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 — recall Z-2579-2023

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