Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030254056

FEI Number

3030254056

Entity Name

SMART DENTAL CAD SOLUTIONS LIMITED

City/State/Country

Zhuhai Guangdong, CN

Establishment Address

5rd Floor,Building 1,No.6 Pingbei 1st Road,Nanping Technological & Industrial Park, Xiangzhou District,, Zhuhai city, Guangdong Province, China., Zhuhai Guangdong 519060, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Smart Dental Cad Solutions Limited (Owner Number: 10089554)

Owner / Operator Contact Address

5rd Floor,Building 1,No.6 Pingbei 1st Road,Nanping Technological & Industrial Park, Xiangzhou District,, Zhuhai city, Guangdong Province, China., Zhuhai, CN-GD 519060, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Restoration, Noble Metal Restoration, Base Metal Full zircinao crown Restoration, resin, crown and bridge Dentures, Partial Ti implant abutment

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJT	Alloy, Gold-Based Noble Metal	Dental	Class 2	872.3060	2023-12-17
NSQ	Restoration, Base Metal	Unknown	Class N	N/A	2023-12-17
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2023-12-17
NSK	Dentures, Partial	Unknown	Class N	N/A	2023-12-17
ELK	Teeth, Artificial, Backing And Facing	Dental	Class 1	872.3910	2023-12-17

Official Correspondent

Xiaoping Liu

US Agent Details

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

Related Public Records

Same Entity

Smart Dental Cad Solutions Limited

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
K915626	Ivoclar North America, Inc.	EZ GOLD	1992-02-25

Similar Registrations

Registration Number	Establishment Name	Location
3003929447	GLOBAL DENTAL TECHNOLOGIES, INC.	Rogers, AR, US
2921595	Sterngold Dental LLC	Attleboro, MA, US
3030154803	A.D.L. DENTAL LAB	Feasterville, PA, US
3011824442	DENTSPLY IH BV	Sevenum Limburg, NL
3007740664	Shenzhen Jiahong Dental Technology Co., Ltd	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030254056. Last updated year: 2026. Please use registration number 3030254056 when referencing this establishment in official correspondence.