Smart MTA
BioMTA · Model SmMTA-10 · UDI-DI 08800027200023
1
510(k) clearances
703
Adverse events
2
Recalls
76
Facilities
Description
SmartMTA is an ideal material for vital pulp therapy and root repair. With a setting time of 150 seconds and no washout, it is ideal for one-visit treatment. SmartMTA contains no heavy metals and will not discolor after application. SmartMTA has a wide variety of clinical indications such as partial and complete pulpotomy for deciduous teeth, direct and indirect pulp capping, base formation, root repair and prevention of discoloration when used for tooth whitening procedures.
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.