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FDA 510(k)

Ceramill A-Temp

K-Number: K191843 · 2019-10-04

ApplicantAmann Girrbach AG
Decision Date2019-10-04
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ceramill A-Temp is the device name listed in this FDA 510(k) record. The listed applicant is Amann Girrbach AG. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K191843. 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 Ceramill A-Temp?

Ceramill A-Temp is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Amann Girrbach AG. The 510(k) number is K191843.

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

Ceramill A-Temp received FDA 510(k) clearance on 2019-10-04, under 510(k) number K191843.

Who is the listed applicant for Ceramill A-Temp?

The FDA 510(k) record lists Amann Girrbach AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ceramill A-Temp?

The FDA product code for Ceramill A-Temp is EBG.

Other records listing Amann Girrbach AG 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.

K260918Zolid LunarisK191836Ceramill A-SplintK171876Ceramill Zolid HT+ white

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

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

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