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FDA 510(k)

Park Dental Research Aligners

K-Number: K180648 · 2019-01-08

ApplicantPark Dental Research Corporation
Decision Date2019-01-08
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Park Dental Research Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Park Dental Research Corporation. It received FDA 510(k) clearance on 2019-01-08 under 510(k) number K180648. 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 Park Dental Research Aligners?

Park Dental Research Aligners is a medical device that received FDA 510(k) clearance on 2019-01-08. The listed applicant is Park Dental Research Corporation. The 510(k) number is K180648.

When did Park Dental Research Aligners receive FDA 510(k) clearance?

Park Dental Research Aligners received FDA 510(k) clearance on 2019-01-08, under 510(k) number K180648.

Who is the listed applicant for Park Dental Research Aligners?

The FDA 510(k) record lists Park Dental Research Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Park Dental Research Aligners?

The FDA product code for Park Dental Research Aligners is NXC.

Other records listing Park Dental Research Corporation 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.

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Related Devices (Code: NXC)

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.

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Official Source

View on FDA Database →

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

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