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FDA 510(k)

DIRECT CROWN NATURAL 1

K-Number: K101814 · 2010-09-27

ApplicantCandulor USA, Inc.
Decision Date2010-09-27
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIRECT CROWN NATURAL 1 is the device name listed in this FDA 510(k) record. The listed applicant is Candulor USA, Inc.. It received FDA 510(k) clearance on 2010-09-27 under 510(k) number K101814. 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 NATURAL 1?

DIRECT CROWN NATURAL 1 is a medical device that received FDA 510(k) clearance on 2010-09-27. The listed applicant is Candulor USA, Inc.. The 510(k) number is K101814.

When did DIRECT CROWN NATURAL 1 receive FDA 510(k) clearance?

DIRECT CROWN NATURAL 1 received FDA 510(k) clearance on 2010-09-27, under 510(k) number K101814.

Who is the listed applicant for DIRECT CROWN NATURAL 1?

The FDA 510(k) record lists Candulor USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIRECT CROWN NATURAL 1?

The FDA product code for DIRECT CROWN NATURAL 1 is EBG.

Related Clinical Trials

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 Candulor USA, Inc. 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.

K122852PHYSIOSTAR NFC

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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