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FDA 510(k)

VarseoSmile Temp

K-Number: K193553 · 2020-05-18

ApplicantBego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG
Decision Date2020-05-18
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VarseoSmile Temp is the device name listed in this FDA 510(k) record. The listed applicant is Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG. It received FDA 510(k) clearance on 2020-05-18 under 510(k) number K193553. 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 VarseoSmile Temp?

VarseoSmile Temp is a medical device that received FDA 510(k) clearance on 2020-05-18. The listed applicant is Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG. The 510(k) number is K193553.

When did VarseoSmile Temp receive FDA 510(k) clearance?

VarseoSmile Temp received FDA 510(k) clearance on 2020-05-18, under 510(k) number K193553.

Who is the listed applicant for VarseoSmile Temp?

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

What is the FDA product code for VarseoSmile Temp?

The FDA product code for VarseoSmile Temp 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 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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