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FDA 510(k)

Dental Handpiece, Model CA160, CA160L, and CA500L

K-Number: K220577 · 2022-07-29

Decision Date2022-07-29
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Handpiece, Model CA160, CA160L, and CA500L is a medical device manufactured by Micro-Nx Co., Ltd.. It received FDA 510(k) clearance on 2022-07-29 under approval number K220577. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Handpiece, Model CA160, CA160L, and CA500L?

Dental Handpiece, Model CA160, CA160L, and CA500L is a medical device that received FDA 510(k) clearance on 2022-07-29. It is manufactured by Micro-Nx Co., Ltd.. The 510(k) number is K220577.

When was Dental Handpiece, Model CA160, CA160L, and CA500L approved by the FDA?

Dental Handpiece, Model CA160, CA160L, and CA500L received FDA 510(k) clearance on 2022-07-29, under approval number K220577.

What company makes Dental Handpiece, Model CA160, CA160L, and CA500L?

Dental Handpiece, Model CA160, CA160L, and CA500L is manufactured by Micro-Nx Co., Ltd..

What is the FDA product code for Dental Handpiece, Model CA160, CA160L, and CA500L?

The FDA product code for Dental Handpiece, Model CA160, CA160L, and CA500L is EGS.

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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.