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,

About This 510(k) Submission

K230895 is an FDA 510(k) clearance for the 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,, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Cefla S.C. (Imola, IT). The FDA issued a Cleared decision on April 1, 2024, 367 days after receiving the submission on March 31, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.