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FDA 510(k)

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

K-Number: K241673 · 2024-10-15

ApplicantShenzhen Piocreat 3D Technology Co., Ltd.
Decision Date2024-10-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Shenzhen Piocreat 3D Technology Co., Ltd.. The 510(k) number is K241673.

When was Denture Base Resin (PN-Denture (Red, White)) approved by the FDA?

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

What company makes Denture Base Resin (PN-Denture (Red, White))?

Denture Base Resin (PN-Denture (Red, White)) is manufactured by Shenzhen Piocreat 3D Technology Co., Ltd..

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.

Related Clinical Trials

NCT07544849 A Randomized Split-Mouth Clinical Trial Comparing Resin Infiltration and Microabrasion for Early Caries Lesions COMPLETED

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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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