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FDA 510(k)

DIRECT CROWN

K-Number: K001884 · 2000-10-25

ApplicantFlexible Dimensions, LLC
Decision Date2000-10-25
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIRECT CROWN is the device name listed in this FDA 510(k) record. The listed applicant is Flexible Dimensions, LLC. It received FDA 510(k) clearance on 2000-10-25 under 510(k) number K001884. 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 DIRECT CROWN?

DIRECT CROWN is a medical device that received FDA 510(k) clearance on 2000-10-25. The listed applicant is Flexible Dimensions, LLC. The 510(k) number is K001884.

When did DIRECT CROWN receive FDA 510(k) clearance?

DIRECT CROWN received FDA 510(k) clearance on 2000-10-25, under 510(k) number K001884.

Who is the listed applicant for DIRECT CROWN?

The FDA 510(k) record lists Flexible Dimensions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIRECT CROWN?

The FDA product code for DIRECT CROWN is EBG.

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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

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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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