Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026312357

FEI Number

3026312357

Entity Name

HANGZHOU SHINING3D DENTAL TECHNOLOGY CO., LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

9-5-2, Tri-River Valley, Wenyan Street, Xiaoshan, Hangzhou Zhejiang 311258, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hangzhou SHINING3D Dental Technology Co., Ltd (Owner Number: 10086991)

Owner / Operator Contact Address

9-5-2, Tri-River Valley, Wenyan Street, Xiaoshan, Hangzhou, CN-ZJ 311258, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Denture Base Resin DT20 Dura-Crown LumiCera Tray Resin TR01 Try-in Resin TN11 A1 Try-in Resin TN11 A2 Try-in Resin TN11 A3 Try-in Resin TN11 A3.5 DT01-LT; DT01-LRP ;DT01-OP ;DT01-DK CX100-A1, CX100-A2, CX100-B1, CX100-BL Try-in Resin TN11 B1; Try-in Resin TN11 B2; Try-in Resin TN11 B3; Try-in Resin TN11 BL; DM03; DM12; OD02; W20; DT01-OR; Indirect Bonding Tray Resin IBT Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) Dura-Arch Splint Soft Resin SS01; Splint Hard Resin SH01

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2025-04-22
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2026-05-15
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2026-05-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-05-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-02-05
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2022-12-29
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-11-17
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2025-11-17
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2025-11-17
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2026-04-27
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2026-04-27
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2023-09-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Hangzhou SHINING3D Dental 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
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
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
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
2950685	CO-ORAL-ITE DENTAL MFG. CO.	DIAMOND SPRINGS, CA, US
3032727	TALON ACRYLICS, INC.	Winchester, OR, US
3008320092	Shandong Huge Dental Material Corporation	Rizhao Shandong, CN
1410097	GC AMERICA INC.	ALSIP, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026312357. Last updated year: 2026. Please use registration number 3026312357 when referencing this establishment in official correspondence.