FDA 510(k)

CURA-Temp

K-Number: K202965 · 2022-12-21

Decision Date2022-12-21

Product CodeEBG

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CURA-Temp is the device name listed in this FDA 510(k) record. The listed applicant is Mgnewton , Ltd.. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K202965. 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 CURA-Temp?

CURA-Temp is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Mgnewton , Ltd.. The 510(k) number is K202965.

When did CURA-Temp receive FDA 510(k) clearance?

CURA-Temp received FDA 510(k) clearance on 2022-12-21, under 510(k) number K202965.

Who is the listed applicant for CURA-Temp?

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

What is the FDA product code for CURA-Temp?

The FDA product code for CURA-Temp is EBG.

Other records listing Mgnewton , 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.

K202963ELEC Master, ELEC Master Dual

Related Devices (Code: EBG)

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.