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FDA 510(k)

TempFIT Temporary Crown and Bridge Resin

K-Number: K251271 · 2025-06-23

ApplicantRizhao Huge Biomaterials Company, Ltd.
Decision Date2025-06-23
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TempFIT Temporary Crown and Bridge Resin is the device name listed in this FDA 510(k) record. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2025-06-23 under 510(k) number K251271. 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 TempFIT Temporary Crown and Bridge Resin?

TempFIT Temporary Crown and Bridge Resin is a medical device that received FDA 510(k) clearance on 2025-06-23. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K251271.

When did TempFIT Temporary Crown and Bridge Resin receive FDA 510(k) clearance?

TempFIT Temporary Crown and Bridge Resin received FDA 510(k) clearance on 2025-06-23, under 510(k) number K251271.

Who is the listed applicant for TempFIT Temporary Crown and Bridge Resin?

The FDA 510(k) record lists Rizhao Huge Biomaterials Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for TempFIT Temporary Crown and Bridge Resin 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 Rizhao Huge Biomaterials Company, Ltd. as applicant

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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.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.K242559Digital TempSprintray, Inc.

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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