Device product
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.
Z-2069-2014
Product summary
- Event
- Event 68480
- Status
- Terminated
- Classification
- Class II
- Quantity
- 528
- Official record key
device-enforcement:Z-2069-2014
Official wording
Reason: 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.
Code information: lot # H13136, exp. August 2014.
Distribution pattern: US distribution to NY and CA
Derived failure modes
-
Labeling or packaging
label does not include