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510(k) Data Aggregation
K Number
K241673Device Name
Denture Base Resin (PN-Denture (Red, White))
Manufacturer
Date Cleared
2024-10-15
(126 days)
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Piocreat 3D Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Denture Base Resin is a light-curable resin indicated for the fabrication of:
•individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area
•denture bases
Denture Base Resin is intended exclusively for professional dental work.
Device Description
The Denture Base Resin is an alternative to traditional heat cured and auto polymerization resins. The resins are available in two (2) different colors ( white, red). Denture Base Resin can be used with PioNext D Series. PioNext D Series printers include a 3D printing system that utilizes Digital Light Process (DLP) technology, with automatic feeding process, and a UV LED (405nm) curing process. The dental appliance is then cured in the PioNext UV-02 curing chamber and sent back to the dentist for try-in and final adjustment.
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