510(k) K892894

S-FILE, S-FINDER, S-ENGINE FILE by Svenska Dental Instruments AB — Product Code EKS

K892894 is an FDA 510(k) premarket notification submitted by Svenska Dental Instruments AB for the device "S-FILE, S-FINDER, S-ENGINE FILE". The FDA issued a decision of Substantially Equivalent on May 24, 1989. The device falls under product code EKS (File, Pulp Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. Svenska Dental Instruments AB has at least 3 other 510(k) clearances on record.