CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED— 510(k) K213022

Name: FDA 510(k) clearance K213022
Creator: U.S. Food and Drug Administration
Published: 2022-05-09

Substantially Equivalent

Cefla S.C.

FDA 510(k) clearance K213022 for CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED, Substantially Equivalent on 2022-05-09. Applicant: Cefla S.C.. Device class: 1.

Clearance details

Applicant: Cefla S.C.
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2021-09-20
Decision date: 2022-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Imola (Bo), IT

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.