FDA 510(k)

“FLNT Base” and “FLNT Temp”

Numéro K : K253380 · 2026-03-02

Date de décision2026-03-02

Code produitEBG

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

“FLNT Base” and “FLNT Temp” is the device name listed in this FDA 510(k) record. The listed applicant is Liaoning Upcera Co., Ltd.. It received FDA 510(k) clearance on 2026-03-02 under 510(k) number K253380. 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 “FLNT Base” and “FLNT Temp”?

“FLNT Base” and “FLNT Temp” is a medical device that received FDA 510(k) clearance on 2026-03-02. The listed applicant is Liaoning Upcera Co., Ltd.. The 510(k) number is K253380.

When did “FLNT Base” and “FLNT Temp” receive FDA 510(k) clearance?

“FLNT Base” and “FLNT Temp” received FDA 510(k) clearance on 2026-03-02, under 510(k) number K253380.

Who is the listed applicant for “FLNT Base” and “FLNT Temp”?

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

What is the FDA product code for “FLNT Base” and “FLNT Temp”?

The FDA product code for “FLNT Base” and “FLNT Temp” is EBG.

Autres dossiers indiquant Liaoning Upcera Co., Ltd. en tant que demandeur

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

K253973Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series K240153Ceramic Etchant (HF-5 and HF-9)K231687Gradual Dental Zirconia Blank K181167Upcera Glaze Paste, Glaze Powder, and Glaze Liquid K162323Tooth Shade Resin Material

Dispositifs connexes (Code : EBG)

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E Exportação K243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.K242559Digital TempSprintray, Inc.

Source officielle

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