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MAARC DENTAL-Calx-O
SHIVA PRODUCTS · Model 9102/1.5x2 · UDI-DI 08906110440403
KIF
Prescription
1
510(k) clearances
703
Adverse events
2
Recalls
76
Facilities
Description
It is a water based white paste consisting of premixed Calcium Hydroxide and Barium Sulphate. Supplied in a multi dose syringe with disposable pre-bent cannulas for dispensing.
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 |
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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.