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FDA 510(k)

Xelis Dental 2.0

K-Number: K193369 · 2020-04-14

ApplicantInfinitt Healthcare Co., Ltd.
Decision Date2020-04-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Xelis Dental 2.0 is a medical device manufactured by Infinitt Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2020-04-14 under approval number K193369. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xelis Dental 2.0?

Xelis Dental 2.0 is a medical device that received FDA 510(k) clearance on 2020-04-14. It is manufactured by Infinitt Healthcare Co., Ltd.. The 510(k) number is K193369.

When was Xelis Dental 2.0 approved by the FDA?

Xelis Dental 2.0 received FDA 510(k) clearance on 2020-04-14, under approval number K193369.

What company makes Xelis Dental 2.0?

Xelis Dental 2.0 is manufactured by Infinitt Healthcare Co., Ltd..

What is the FDA product code for Xelis Dental 2.0?

The FDA product code for Xelis Dental 2.0 is LLZ.

Other Devices by Infinitt Healthcare Co., Ltd.

K172803Infinitt PACS 7.0 K193498Infinitt RT PACS K243449INFINITT DPS

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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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