FDA-Device2014-07-23Class II
Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration.
Axcentria Pharmaceuticals, LLC
Hazard
One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use.
Sold states
US distribution to NY and CA
Affected count
528
Manufactured in
306 Keystone Dr, Unit B, Telford, PA, United States
Products
Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2069-2014Don't want to check this manually?
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