510(k) K000710

MD 10, SEM, SM 12, CBM by NOUVAG AG — Product Code EFB

K000710 is an FDA 510(k) premarket notification submitted by NOUVAG AG for the device "MD 10, SEM, SM 12, CBM". The FDA issued a decision of Substantially Equivalent on May 11, 2000. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. NOUVAG AG has at least 10 other 510(k) clearances on record.