510(k) K230895

CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, by Cefla S.C. — Product Code EBW

K230895 is an FDA 510(k) premarket notification submitted by Cefla S.C. for the device "CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,". The FDA issued a decision of Substantially Equivalent on April 1, 2024. 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.