Cleared Traditional

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 (FDA 510(k) Clearance)

K213022 · Cefla S.C. · Dental device

May 2022

Decision

231d

Days

Class 1

Risk

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. This device is classified as 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 FDA review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K213022 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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