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FDA 510(k)

FREEPRINT temp

K-Number: K200273 · 2020-10-27

ApplicantDetax GmbH & Co. KG
Decision Date2020-10-27
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FREEPRINT temp is the device name listed in this FDA 510(k) record. The listed applicant is Detax GmbH & Co. KG. It received FDA 510(k) clearance on 2020-10-27 under 510(k) number K200273. 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 FREEPRINT temp?

FREEPRINT temp is a medical device that received FDA 510(k) clearance on 2020-10-27. The listed applicant is Detax GmbH & Co. KG. The 510(k) number is K200273.

When did FREEPRINT temp receive FDA 510(k) clearance?

FREEPRINT temp received FDA 510(k) clearance on 2020-10-27, under 510(k) number K200273.

Who is the listed applicant for FREEPRINT temp?

The FDA 510(k) record lists Detax GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FREEPRINT temp?

The FDA product code for FREEPRINT temp is EBG.

Other records listing Detax GmbH & Co. KG 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.

K200461Freeprint dentureK162654mollosil plus

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 ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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