510(k) K801687

TORX MICRO-MOTOR LOW SPEED HANDPIECE by Pacific Dental Corp. — Product Code EKX

K801687 is an FDA 510(k) premarket notification submitted by Pacific Dental Corp. for the device "TORX MICRO-MOTOR LOW SPEED HANDPIECE". The FDA issued a decision of Substantially Equivalent on August 4, 1980. 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.