FDA 510(k)

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

Numéro K : K213022 · 2022-05-09

Date de décision2022-05-09

Code produitEBW

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED is the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2022-05-09 under 510(k) number K213022. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is 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?

CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED is a medical device that received FDA 510(k) clearance on 2022-05-09. The listed applicant is Cefla S.C.. The 510(k) number is K213022.

When did CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED receive FDA 510(k) clearance?

CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED received FDA 510(k) clearance on 2022-05-09, under 510(k) number K213022.

Who is the listed applicant 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?

The FDA 510(k) record lists Cefla S.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code 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?

The FDA product code 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 is EBW.

Essais cliniques associés

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Autres dossiers indiquant Cefla S.C. en tant que demandeur

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Source officielle

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