510(k) K810923

LEE ENDOFILL, ROOT CANAL FILLING RESIN by Lee Pharmaceuticals — Product Code KIF

K810923 is an FDA 510(k) premarket notification submitted by Lee Pharmaceuticals for the device "LEE ENDOFILL, ROOT CANAL FILLING RESIN". The FDA issued a decision of Substantially Equivalent on April 21, 1981. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Lee Pharmaceuticals has at least 10 other 510(k) clearances on record.