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,— 510(k) K230895

Name: FDA 510(k) clearance K230895
Creator: U.S. Food and Drug Administration
Published: 2024-04-01

Substantially Equivalent

Cefla S.C.

FDA 510(k) clearance K230895 for 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,, Substantially Equivalent on 2024-04-01. 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: 2023-03-31
Decision date: 2024-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Imola, 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.