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FDA 510(k)

NEW OUTLINE

K-Number: K023079 · 2002-10-30

ApplicantAnaxdent GmbH
Decision Date2002-10-30
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEW OUTLINE is the device name listed in this FDA 510(k) record. The listed applicant is Anaxdent GmbH. It received FDA 510(k) clearance on 2002-10-30 under 510(k) number K023079. 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 NEW OUTLINE?

NEW OUTLINE is a medical device that received FDA 510(k) clearance on 2002-10-30. The listed applicant is Anaxdent GmbH. The 510(k) number is K023079.

When did NEW OUTLINE receive FDA 510(k) clearance?

NEW OUTLINE received FDA 510(k) clearance on 2002-10-30, under 510(k) number K023079.

Who is the listed applicant for NEW OUTLINE?

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

What is the FDA product code for NEW OUTLINE?

The FDA product code for NEW OUTLINE is EBG.

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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.

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Other records listing Anaxdent 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.

K112044ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A

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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