510(k) K821739

J. MORITA FLEX M-3 TORX HARDPIECE by Pacific Dental Corp. — Product Code EKX

K821739 is an FDA 510(k) premarket notification submitted by Pacific Dental Corp. for the device "J. MORITA FLEX M-3 TORX HARDPIECE". The FDA issued a decision of Substantially Equivalent on June 25, 1982. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Pacific Dental Corp. has at least 10 other 510(k) clearances on record.