510(k) K152959

Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes by Sybron Dental Specialties — Product Code KIF

K152959 is an FDA 510(k) premarket notification submitted by Sybron Dental Specialties for the device "Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes". The FDA issued a decision of Substantially Equivalent on April 14, 2016. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Sybron Dental Specialties has at least 10 other 510(k) clearances on record.