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FDA 510(k)

NUBRACE INVISIBLE REMOVABLE ORTHODONTICS

K-Number: K073121 · 2009-02-12

ApplicantNubrace, Inc.
Decision Date2009-02-12
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NUBRACE INVISIBLE REMOVABLE ORTHODONTICS is the device name listed in this FDA 510(k) record. The listed applicant is Nubrace, Inc.. It received FDA 510(k) clearance on 2009-02-12 under 510(k) number K073121. 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 NUBRACE INVISIBLE REMOVABLE ORTHODONTICS?

NUBRACE INVISIBLE REMOVABLE ORTHODONTICS is a medical device that received FDA 510(k) clearance on 2009-02-12. The listed applicant is Nubrace, Inc.. The 510(k) number is K073121.

When did NUBRACE INVISIBLE REMOVABLE ORTHODONTICS receive FDA 510(k) clearance?

NUBRACE INVISIBLE REMOVABLE ORTHODONTICS received FDA 510(k) clearance on 2009-02-12, under 510(k) number K073121.

Who is the listed applicant for NUBRACE INVISIBLE REMOVABLE ORTHODONTICS?

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

What is the FDA product code for NUBRACE INVISIBLE REMOVABLE ORTHODONTICS?

The FDA product code for NUBRACE INVISIBLE REMOVABLE ORTHODONTICS is NXC.

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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.

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