FDA 510(k)

Denture Base Resin (PN-Denture (Red, White))

Numéro K : K241673 · 2024-10-15

DemandeurShenzhen Piocreat 3D Technology Co., Ltd.

Date de décision2024-10-15

Code produitEBF

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

Denture Base Resin (PN-Denture (Red, White)) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Piocreat 3D Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-15 under 510(k) number K241673. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Denture Base Resin (PN-Denture (Red, White))?

Denture Base Resin (PN-Denture (Red, White)) is a medical device that received FDA 510(k) clearance on 2024-10-15. The listed applicant is Shenzhen Piocreat 3D Technology Co., Ltd.. The 510(k) number is K241673.

When did Denture Base Resin (PN-Denture (Red, White)) receive FDA 510(k) clearance?

Denture Base Resin (PN-Denture (Red, White)) received FDA 510(k) clearance on 2024-10-15, under 510(k) number K241673.

Who is the listed applicant for Denture Base Resin (PN-Denture (Red, White))?

The FDA 510(k) record lists Shenzhen Piocreat 3D Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Denture Base Resin (PN-Denture (Red, White))?

The FDA product code for Denture Base Resin (PN-Denture (Red, White)) is EBF.

Essais cliniques associés

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Source officielle

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