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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 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.

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. 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.

Related Devices (Code: EBF)

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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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