Home › Zendo Direct AG › Select Calcium Hydroxide Liner LC
Select Calcium Hydroxide Liner LC
Zendo Direct AG · Model CAL-LINER · UDI-DI 07540208000387
EJK
Prescription
10
510(k) clearances
14
Adverse events
1
Recalls
50
Facilities
Description
Light cure radiopaque calcium hydroxide liner - 2 ml syringe
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-06-05 | Axcentria Pharmaceuticals, LLC | 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.