FDA 510(k)

TEMP MASTER, PMMA-based dental resin

Numéro K : K243951 · 2025-02-21

DemandeurTaiwan Dental Materials Co., Ltd.

Date de décision2025-02-21

Code produitEBG

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : EBG)

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 Exportação K242559Digital TempSprintray, Inc.

Source officielle

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