FDA · official record K233356Substantially Equivalent

Illusion Aligner Pro: Illusion Aligner FLX

Name: Illusion Aligner Pro: Illusion Aligner FLX — FDA K233356
Creator: Laxmi Dental Export Pvt., Ltd.
Keywords: Illusion Aligner Pro: Illusion Aligner FLX, Illusion Aligner Pro: Illusion Aligner FLX, K233356, NXC, FDA

United StatesNXCLaxmi Dental Export Pvt., Ltd.

Verified

Official record identity

FDA application number: K233356
Decision date: August 08, 2024
Published decision: Substantially Equivalent

Classification

Product code: NXC

Published parties

Applicant: Laxmi Dental Export Pvt., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2023-09-29
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.5470

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.