510(k) K213022

CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED by Cefla S.C. — Product Code EBW

K213022 is an FDA 510(k) premarket notification submitted by Cefla S.C. for the device "CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED". The FDA issued a decision of Substantially Equivalent on May 9, 2022. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Cefla S.C. has at least 10 other 510(k) clearances on record.