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FDA 510(k)

DENTCA Crown and Bridge

K-Number: K192806 · 2020-02-05

ApplicantDentca, Inc.
Decision Date2020-02-05
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTCA Crown and Bridge is the device name listed in this FDA 510(k) record. The listed applicant is Dentca, Inc.. It received FDA 510(k) clearance on 2020-02-05 under 510(k) number K192806. 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 DENTCA Crown and Bridge?

DENTCA Crown and Bridge is a medical device that received FDA 510(k) clearance on 2020-02-05. The listed applicant is Dentca, Inc.. The 510(k) number is K192806.

When did DENTCA Crown and Bridge receive FDA 510(k) clearance?

DENTCA Crown and Bridge received FDA 510(k) clearance on 2020-02-05, under 510(k) number K192806.

Who is the listed applicant for DENTCA Crown and Bridge?

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

What is the FDA product code for DENTCA Crown and Bridge?

The FDA product code for DENTCA Crown and Bridge is EBG.

Other records listing Dentca, 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.

K261474DENTCA Tru FlexibleK220042Dentca Base Premium, Dentca Base Hi-ImpactK172398DENTCA DENTURE TeethK162044Dentca Denture Base II

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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