Data / Medical devices / China / Shenzhen Piocreat 3D Technology Co., Ltd
Shenzhen Piocreat 3D Technology Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Piocreat 3D Technology Co., Ltd is registered with the FDA (registration 3022545323) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 15, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3022545323
- Address
- 3rd Floor, Building 1, No. 156 Huawang Road, Langkou Community, Dalang Street, Longhua District, Shenzhen Guangdong, China, 518109
- Owner or operator
- Shenzhen Piocreat 3D Technology Co., Ltd (10087763)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 6, 2023
- Registered through
- 2026
- Brand names listed
- Denture Base Resin(PN-Denture (Red,White)), PioNext Dental Model Resin (Models: PN-IBT, PN-Try-in, PN-Splint, PN-Splint Flex), PioNext Dental Model Resin (Models: PN-Model, PN-Model 2, PN-RD, PN-WM, PN-CIT, PN-SG, PN-Cast, PN-GM)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 15, 2024 | K241673 | Denture Base Resin (PN-Denture (Red, White)) | EBF | Substantially Equivalent | Shenzhen Piocreat 3D Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Material, Tooth Shade, Resin
- All makers of Denture, Plastic, Teeth
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Additively Manufactured, Preformed, Resin Denture Tooth
- All makers of Material, Impression Tray, Resin
Updated October 15, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.