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MAARC DENTAL - Sealmax +
SHIVA PRODUCTS · Model 8011/001 · UDI-DI 08906110443053
KIF
Prescription
1
510(k) clearances
703
Adverse events
2
Recalls
76
Facilities
Description
Sealmax+ is a MTA based Bioceramic root canal sealing material supplied in the form of powder and resin. The powder and resin are mixed to produce a root canal sealing material of excellent sealing capacity and tissue compatibility. As a result of its close adaptation to the walls and hydrophobic nature, Sealmax + allows tight sealing of root canal during obturation.
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.