510(k) K243546

AH Plus Endodontic Sealer by Dentsply Sirona, Inc. — Product Code KIF

K243546 is an FDA 510(k) premarket notification submitted by Dentsply Sirona, Inc. for the device "AH Plus Endodontic Sealer". The FDA issued a decision of Substantially Equivalent on February 13, 2025. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Dentsply Sirona, Inc. has at least 10 other 510(k) clearances on record.