FDA 510(k)

Illusion Aligner Pro: Illusion Aligner FLX

Numéro K : K233356 · 2024-08-08

Date de décision2024-08-08

Code produitNXC

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

Illusion Aligner Pro: Illusion Aligner FLX is the device name listed in this FDA 510(k) record. The listed applicant is Laxmi Dental Export Pvt., Ltd.. It received FDA 510(k) clearance on 2024-08-08 under 510(k) number K233356. 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 Illusion Aligner Pro: Illusion Aligner FLX?

Illusion Aligner Pro: Illusion Aligner FLX is a medical device that received FDA 510(k) clearance on 2024-08-08. The listed applicant is Laxmi Dental Export Pvt., Ltd.. The 510(k) number is K233356.

When did Illusion Aligner Pro: Illusion Aligner FLX receive FDA 510(k) clearance?

Illusion Aligner Pro: Illusion Aligner FLX received FDA 510(k) clearance on 2024-08-08, under 510(k) number K233356.

Who is the listed applicant for Illusion Aligner Pro: Illusion Aligner FLX?

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

What is the FDA product code for Illusion Aligner Pro: Illusion Aligner FLX?

The FDA product code for Illusion Aligner Pro: Illusion Aligner FLX 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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