Home › ORMCO CORPORATION › Pulp Canal Sealer EWT
Pulp Canal Sealer EWT
ORMCO CORPORATION · Model 24746 · UDI-DI 00889989074147
KIF
Prescription
1
510(k) clearances
704
Adverse events
2
Recalls
76
Facilities
Description
Root Canal Sealer - Extended Work Time (1 - Jar (10.5g), 1 - Bottle (4mL))
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-08-31 | Ormco/Sybronendo | SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 20 |
| 2009-02-23 | Sybron Dental Specialties | Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in the catalyst. This crystallization may affect proper canal filling by pre |
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.