FDA 510(k)

Dental Handpiece

K-Number: K192809 · 2020-08-25

Decision Date2020-08-25

Product CodeEFA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Dental Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Nx Co., Ltd.. It received FDA 510(k) clearance on 2020-08-25 under 510(k) number K192809. The device is classified under product code EFA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Handpiece?

Dental Handpiece is a medical device that received FDA 510(k) clearance on 2020-08-25. The listed applicant is Micro-Nx Co., Ltd.. The 510(k) number is K192809.

When did Dental Handpiece receive FDA 510(k) clearance?

Dental Handpiece received FDA 510(k) clearance on 2020-08-25, under 510(k) number K192809.

Who is the listed applicant for Dental Handpiece?

The FDA 510(k) record lists Micro-Nx Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Handpiece?

The FDA product code for Dental Handpiece is EFA.

Other records listing Micro-Nx Co., Ltd. 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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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.