FDA 510(k)

NEOLab Clear Aligners

K-Number: K203339 · 2021-01-06

Decision Date2021-01-06

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

NEOLab Clear Aligners is the device name listed in this FDA 510(k) record. The listed applicant is New England Ortho Lab, Inc.. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K203339. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOLab Clear Aligners?

NEOLab Clear Aligners is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is New England Ortho Lab, Inc.. The 510(k) number is K203339.

When did NEOLab Clear Aligners receive FDA 510(k) clearance?

NEOLab Clear Aligners received FDA 510(k) clearance on 2021-01-06, under 510(k) number K203339.

Who is the listed applicant for NEOLab Clear Aligners?

The FDA 510(k) record lists New England Ortho Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEOLab Clear Aligners?

The FDA product code for NEOLab Clear Aligners is NXC.

Other records listing New England Ortho Lab, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192338NEOLab Clear Aligners

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.