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FDA 510(k)

ARTEGRAL IMCROWN

K-Number: K061809 · 2006-09-13

ApplicantMerz Dental GmbH
Decision Date2006-09-13
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARTEGRAL IMCROWN is the device name listed in this FDA 510(k) record. The listed applicant is Merz Dental GmbH. It received FDA 510(k) clearance on 2006-09-13 under 510(k) number K061809. 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 ARTEGRAL IMCROWN?

ARTEGRAL IMCROWN is a medical device that received FDA 510(k) clearance on 2006-09-13. The listed applicant is Merz Dental GmbH. The 510(k) number is K061809.

When did ARTEGRAL IMCROWN receive FDA 510(k) clearance?

ARTEGRAL IMCROWN received FDA 510(k) clearance on 2006-09-13, under 510(k) number K061809.

Who is the listed applicant for ARTEGRAL IMCROWN?

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

What is the FDA product code for ARTEGRAL IMCROWN?

The FDA product code for ARTEGRAL IMCROWN is EBG.

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Other records listing Merz Dental GmbH 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.

K173124PEEK BiosolutionK130076PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCSK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHK080556ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADESK071548WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLOREDK030588ARTEGRAL AND POLYSTAR SELECTION

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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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