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FDA 510(k)

Resin for Temporary Crown & Bridge

K-Number: K180657 · 2018-12-07

ApplicantDentis Co., Ltd.
Decision Date2018-12-07
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Resin for Temporary Crown & Bridge is the device name listed in this FDA 510(k) record. The listed applicant is Dentis Co., Ltd.. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K180657. 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 Resin for Temporary Crown & Bridge?

Resin for Temporary Crown & Bridge is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K180657.

When did Resin for Temporary Crown & Bridge receive FDA 510(k) clearance?

Resin for Temporary Crown & Bridge received FDA 510(k) clearance on 2018-12-07, under 510(k) number K180657.

Who is the listed applicant for Resin for Temporary Crown & Bridge?

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

What is the FDA product code for Resin for Temporary Crown & Bridge?

The FDA product code for Resin for Temporary Crown & Bridge 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.

NCT07632443PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary RestorationsRECRUITINGNCT03716817TetricCAD Crown Clinical StudyCOMPLETED

Other records listing Dentis Co., Ltd. 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.

K253493Dentis SQ-SL AXEL FixtureK241065ChecQ (AC100)K233921Luvis Chair (LC700C)K241063s-Clean ScanHealing AbutmentK240511Dentis s-Clean SQ-SL FixtureK233544MESHEET

View all 31 devices →

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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