FDA 510(k)

Xelis Dental 2.0

K-Number: K193369 · 2020-04-14

Decision Date2020-04-14

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Xelis Dental 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Infinitt Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2020-04-14 under 510(k) 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. The listed applicant is Infinitt Healthcare Co., Ltd.. The 510(k) number is K193369.

When did Xelis Dental 2.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for Xelis Dental 2.0?

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

What is the FDA product code for Xelis Dental 2.0?

The FDA product code for Xelis Dental 2.0 is LLZ.

Other records listing Infinitt Healthcare 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.

K243449INFINITT DPS K193498Infinitt RT PACS K172803Infinitt PACS 7.0

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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.