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FDA 510(k)

Park Dental Research Aligners

K-Number: K180648 · 2019-01-08

Decision Date2019-01-08
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Park Dental Research Aligners is a medical device manufactured by Park Dental Research Corporation. It received FDA 510(k) clearance on 2019-01-08 under approval 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. It is manufactured by Park Dental Research Corporation. The 510(k) number is K180648.

When was Park Dental Research Aligners approved by the FDA?

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

What company makes Park Dental Research Aligners?

Park Dental Research Aligners is manufactured by Park Dental Research Corporation.

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

The FDA product code for Park Dental Research Aligners 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.