FDA 510(k)

Fixtemp® C&B 4:1

K-Number: K241226 · 2024-05-31

Decision Date2024-05-31

Product CodeEBG

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Fixtemp® C&B 4:1 is the device name listed in this FDA 510(k) record. The listed applicant is Dreve Denatmid GmbH. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K241226. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fixtemp® C&B 4:1?

Fixtemp® C&B 4:1 is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Dreve Denatmid GmbH. The 510(k) number is K241226.

When did Fixtemp® C&B 4:1 receive FDA 510(k) clearance?

Fixtemp® C&B 4:1 received FDA 510(k) clearance on 2024-05-31, under 510(k) number K241226.

Who is the listed applicant for Fixtemp® C&B 4:1?

The FDA 510(k) record lists Dreve Denatmid GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fixtemp® C&B 4:1?

The FDA product code for Fixtemp® C&B 4:1 is EBG.

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E Exportação K243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials 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.