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FDA 510(k)

P pro Crown & Bridge

K-Number: K200039 · 2020-07-31

ApplicantDeltamed GmbH
Decision Date2020-07-31
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

P pro Crown & Bridge is the device name listed in this FDA 510(k) record. The listed applicant is Deltamed GmbH. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K200039. 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 P pro Crown & Bridge?

P pro Crown & Bridge is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Deltamed GmbH. The 510(k) number is K200039.

When did P pro Crown & Bridge receive FDA 510(k) clearance?

P pro Crown & Bridge received FDA 510(k) clearance on 2020-07-31, under 510(k) number K200039.

Who is the listed applicant for P pro Crown & Bridge?

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

What is the FDA product code for P pro Crown & Bridge?

The FDA product code for P pro Crown & Bridge is EBG.

Other records listing Deltamed 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.

K2437203Delta UNlimitedK230341ACRIFIXK2125413Delta Denture Base - 3Delta Denture Bond - 3Delta Denture FixK2118043Delta Crown

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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