FDA Device Intelligence
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Resin, Root Canal Filling

FDA product code KIF · Class 2 · Dental

423
Registered devices
703
Adverse events
2
Recalls
144
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2016-08-31Ormco/SybronendoSybronEndo 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 e
2009-02-23Sybron Dental SpecialtiesSybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in the catalyst. This crystallization may affect proper

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.