FDA 510(k)

DentCare Aligners

Numéro K : K222918 · 2022-11-25

Date de décision2022-11-25

Code produitNXC

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

DentCare Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Dentcare Dental Lab Pvt , Ltd.. It received FDA 510(k) clearance on 2022-11-25 under 510(k) number K222918. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the DentCare Aligners?

DentCare Aligners is a medical device that received FDA 510(k) clearance on 2022-11-25. The listed applicant is Dentcare Dental Lab Pvt , Ltd.. The 510(k) number is K222918.

When did DentCare Aligners receive FDA 510(k) clearance?

DentCare Aligners received FDA 510(k) clearance on 2022-11-25, under 510(k) number K222918.

Who is the listed applicant for DentCare Aligners?

The FDA 510(k) record lists Dentcare Dental Lab Pvt , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DentCare Aligners?

The FDA product code for DentCare Aligners is NXC.

Essais cliniques associés

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Dispositifs connexes (Code : NXC)

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited K250739Primeprint Direct AlignerDreve Dentamid GmbH

Source officielle

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