Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015353992

FEI Number

3015353992

Entity Name

HUILE DENTURE TECHNOLOGY(HONGKONG)CO,LIMITED

City/State/Country

HONG KONG Hong Kong, CN

Establishment Address

FLAT A(RM7) 20/F YOUNG YA IND BLDG 381-389 SHATSUI ROAD TSUEN WAN NEW TERRITORIES, HONG KONG Hong Kong 999077, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Remanufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

HUILE DENTURE TECHNOLOGY(HONGKONG)CO,LIMITED (Owner Number: 10060321)

Owner / Operator Contact Address

FLAT A(RM7) 20/F YOUNG YA IND BLDG 381-389 SHATSUI ROAD TSUEN WAN NEW TERRITORIES, HONG KONG, CN-HK 999077, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Valplast Clear aligner Porcelain fused to metal crown/bridges E.max crown/bridge zirconia crown/bridges arylic dentures metal framework dentures Porcelain fused to metal crown/bridges E.max crown/bridge zirconia crown/bridges arylic dentures Valplast

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSK	Dentures, Partial	Unknown	Class N	N/A	2020-11-09
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2019-12-11
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2020-11-09
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2020-11-09
ELJ	Teeth, Artificial, Posterior With Metal Insert	Dental	Class 1	872.3900	2019-04-25

Official Correspondent

HUIXIN GAO

US Agent Details

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

Related Public Records

Same Entity

HUILE DENTURE TECHNOLOGY(HONGKONG)CO,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
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

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 3015353992. Last updated year: 2026. Please use registration number 3015353992 when referencing this establishment in official correspondence.