FDA Registration
Active
🇨🇳 China
SHENZHEN PIOCREAT 3D TECHNOLOGY CO., LTD
Reg #: 3022545323
·
FEI: 3022545323
·
Expires 2026
Products
6
Proprietary Names
3
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- SHENZHEN PIOCREAT 3D TECHNOLOGY CO., LTD
- Registration Number
- 3022545323
- FEI Number
- 3022545323
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3rd Floor, Building 1, No. 156 Huawang Road, Langkou Community, Dalang Street, Longhua District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K241673
Owner / Operator
- Firm Name
- Shenzhen Piocreat 3D Technology Co., Ltd
- Operator Number
- 10087763
- Address
- Rm 1308 Bldg 3, Jincheng Ind Park,Longhua Dist
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518109
- Country
- CN
- Correspondent
- Jason Cai
US Agent
- Business Name
- Simply Shipped, LLC
- Contact Name
- Mike Ryan
- Address
- 12745 W Townsend St
- City
- Brookfield
- State
- WI
- ZIP
- 53005
- Country
- US
- [email protected]
- Phone
- 414 3264114
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2023-04-06 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2024-10-29 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2024-10-29 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2024-10-29 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2024-10-29 |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | Class 2 | Dental | No | 2024-10-29 |
Proprietary Names
PioNext Dental Model Resin (Models: PN-Model, PN-Model 2, PN-RD, PN-WM, PN-CIT, PN-SG, PN-Cast, PN-GM)
PioNext Dental Model Resin (Models: PN-IBT, PN-Try-in, PN-Splint, PN-Splint Flex)
Denture Base Resin(PN-Denture (Red,White))
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device