FDA 510(k)

Temporis, Irix Plus

K-Number: K231142 · 2024-04-25

Decision Date2024-04-25

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Temporis, Irix Plus is the device name listed in this FDA 510(k) record. The listed applicant is Dws S.R.L.. It received FDA 510(k) clearance on 2024-04-25 under 510(k) number K231142. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Temporis, Irix Plus?

Temporis, Irix Plus is a medical device that received FDA 510(k) clearance on 2024-04-25. The listed applicant is Dws S.R.L.. The 510(k) number is K231142.

When did Temporis, Irix Plus receive FDA 510(k) clearance?

Temporis, Irix Plus received FDA 510(k) clearance on 2024-04-25, under 510(k) number K231142.

Who is the listed applicant for Temporis, Irix Plus?

The FDA 510(k) record lists Dws S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Temporis, Irix Plus?

The FDA product code for Temporis, Irix Plus is EBF.

Related Devices (Code: EBF)

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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group International K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group International K260805Dual CoreVericom Co., Ltd.

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.