Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022545323

FEI Number

3022545323

Entity Name

SHENZHEN PIOCREAT 3D TECHNOLOGY CO., LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

3rd Floor, Building 1, No. 156 Huawang Road, Langkou Community, Dalang Street, Longhua District, Shenzhen Guangdong 518109, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Piocreat 3D Technology Co., Ltd (Owner Number: 10087763)

Owner / Operator Contact Address

Rm 1308 Bldg 3, Jincheng Ind Park,Longhua Dist, Shenzhen, CN-GD 518109, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241673

PMA Number

N/A

All Registered 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))

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2023-04-06
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2024-10-29
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-10-29
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2024-10-29
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2024-10-29
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2024-10-29

Official Correspondent

Jason Cai

US Agent Details

Mike Ryan Business: Simply Shipped, LLC Email: simplyshipped.agent@gmail.com Phone: (414) 3264114

Related Public Records

Same Entity

Shenzhen Piocreat 3D Technology Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3010622180	MEGA-PHYSIK Ges. fuer physikalische Messtechnik mbh Co KG	Rastatt Baden-Wurttemberg, DE
3009509745	DENT A PHARM PRODUKTIONSGESELLSCHAFT MBH	Barmstedt Schleswig-Holstein, DE
2411056	BUFFALO DENTAL MFG. CO., INC.	SYOSSET, NY, US
1417846	FRICKE DENTAL MFG. CO.	Streamwood, IL, US
3016447764	DSI DENTAL SOLUTIONS LTD	Ashdod Southern, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022545323. Last updated year: 2026. Please use registration number 3022545323 when referencing this establishment in official correspondence.