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FDA 510(k)

TEMP MASTER, PMMA-based dental resin

K-Number: K243951 · 2025-02-21

ApplicantTaiwan Dental Materials Co., Ltd.
Decision Date2025-02-21
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMP MASTER, PMMA-based dental resin is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Dental Materials Co., Ltd.. It received FDA 510(k) clearance on 2025-02-21 under 510(k) number K243951. 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 TEMP MASTER, PMMA-based dental resin?

TEMP MASTER, PMMA-based dental resin is a medical device that received FDA 510(k) clearance on 2025-02-21. The listed applicant is Taiwan Dental Materials Co., Ltd.. The 510(k) number is K243951.

When did TEMP MASTER, PMMA-based dental resin receive FDA 510(k) clearance?

TEMP MASTER, PMMA-based dental resin received FDA 510(k) clearance on 2025-02-21, under 510(k) number K243951.

Who is the listed applicant for TEMP MASTER, PMMA-based dental resin?

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

What is the FDA product code for TEMP MASTER, PMMA-based dental resin?

The FDA product code for TEMP MASTER, PMMA-based dental resin is EBG.

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 ExportaçãoK242559Digital 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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