Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006973441

FEI Number

3006973441

Entity Name

Topway Dental Laboratory Co., Ltd

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

8th Floor, Building 1, Jinchi Exhibition Innovation Park, No. 59 Haoye Road, Zhancheng Community, Fuhai Street, Baoan District, Shenzhen Guangdong 518103, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Topway Dental Laboratory Co., Ltd (Owner Number: 10036623)

Owner / Operator Contact Address

8th Floor, Building 1, Jinchi Exhibition Innovation Park, No. 59 Haoye Road, Zhancheng Community, Fuhai Street ,Baoan District, Shenzhen, CN-GD 518103, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042658

PMA Number

N/A

All Registered Proprietary Names

Articulators Preformed Impression Tray Endosseous Dental Implant Abutment

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJP	Articulators	Dental	Class 1	872.3150	2011-05-18
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2011-05-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-05-18

Official Correspondent

Jack Yu

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

Topway Dental Laboratory 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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

Similar Registrations

Registration Number	Establishment Name	Location
3015131021	SCHOEPF FERTIGUNGSTECHNIK GMBH	Bludesch Vorarlberg, AT
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
3011511773	Candulor Dental GmbH	Rielasingen-Worblingen Baden-Wurttemberg, DE
1043617	WHIP-MIX CORP.	LOUISVILLE, KY, US
3001297506	DARLEYS SURGICAL CO.	SIALKOT, PUNJAB, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006973441. Last updated year: 2026. Please use registration number 3006973441 when referencing this establishment in official correspondence.