510(k) K990682

PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) by Nsk Nakanishi, Inc. — Product Code EKX

K990682 is an FDA 510(k) premarket notification submitted by Nsk Nakanishi, Inc. for the device "PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)". The FDA issued a decision of Substantially Equivalent on March 24, 1999. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Nsk Nakanishi, Inc. has at least 10 other 510(k) clearances on record.