Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039441248

FEI Number

3039441248

Entity Name

ISTAR DENTAL LAB

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 303, Yuheng Building, Xinggang Tongchuanghui, No. 6099 Bao'an Avenue, Xinhe Community, Fuhai Subdistrict, Bao'an District, Shenzhen Guangdong 518100, CN

Establishment Type(s)

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

Owner / Operator

Istar dental lab (Owner Number: 10093740)

Owner / Operator Contact Address

Room 303, Yuheng Building, Xinggang Tongchuanghui, No. 6099 Bao'an Avenue, Xinhe Community, Fuhai Subdistrict, Bao'an District, Shenzhen, CN-GD 518100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Valplast: PRD-upper and lower Clear Aligner: Essix and TPU

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSK	Dentures, Partial	Unknown	Class N	N/A	2025-06-30
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2025-06-30

Official Correspondent

Nan Zeng

US Agent Details

Yueting Zhu Business: SOUTH BAY INNOVATION LLC Email: southbayinnovation@southbayinnovation.com Phone: (424) 3769142

Related Public Records

Same Entity

Istar dental lab

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3007268434	ADS DENTAL LAB LTD.	Shenzhen Guangdong, CN
3038291058	ADVANCE DENTAL EXPORT PRIVATE LIMITED	Surat Gujarat, IN
3011275893	PROMAX DENTAL LABORATORY	Zhuhai Guangdong, CN
3014270094	M/S LEIXIR RESOURCES PVT. LTD	GURUGRAM Haryana, IN
3010594724	PREFERRED DENTAL LABORATORY, INC.	Roseland, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039441248. Last updated year: 2026. Please use registration number 3039441248 when referencing this establishment in official correspondence.