Cleared Traditional

CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED

K213022 · Cefla S.C. · Dental

May 2022

Decision

231d

Days

Class 1

Risk

About This 510(k) Submission

K213022 is an FDA 510(k) clearance for the CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on May 9, 2022, 231 days after receiving the submission on September 20, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K213022 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2021
Decision Date	May 09, 2022
Days to Decision	231 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF