Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013600135

FEI Number

3013600135

Entity Name

EKONG TECHNOLOGY CO., LIMITED.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

201-202 Building 1, Sanyu Industrial, Xinwei Fourth Industrial Zone, Xinzhuang Community, Matan Street, Guangming District, Shenzhen Guangdong 518106, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ekong Technology Co., Limited. (Owner Number: 10055631)

Owner / Operator Contact Address

201-202 Building 1, Sanyu Industrial, Xinwei Fourth Industrial Zone, Xinzhuang Community, Matan Street, Guangming District, Shenzhen, CN-GD 518106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disinfectant box for denture, Toothbrush sterilization box Anti Snore Mouth Piece; Snoring Stopper; Anti Snore Mouth Tray; Stop Snoring Solution; Anti Snore Kit; Stop Snoring Solution; Anti Snore Kit; Stop Snoring Device Cheek Retractor; Mouth Opener; Lip Retractor toothbrush; Plastic toothbrush; Bamboo toothbrush Aligner removal tool, Aligner removal, Retainer removal water flosser/ portable water flosser / oral irrigator water flosser / mini water flosser/ electric water flosser Mini Light 1led/3led /5led;Teeth Whitening Light 8led/16led Plusma Light; Teeth Whitening Light; Teeth whitening Led Light; Portable Teeth Whitening Light Teeth Whitening Mini Light; Teeth Whitening Mouth Tray Led Light; Teeth Whitening Mouth Tray Light Smart Teeth Whitening Device; Smart Teeth Whitening Light; Teeth Whitening Lamp; Teeth Whitening Accelerator Vitamin E Swab Dental Dam; Dental Gum Dam; Gum Protector Gel; Gingival Protection Gel Dry Strips; Dissolving Strip; Teeth Whitening Pen; Bleaching Pen, Teeth Whitener; Teeth Whitening Gel Double Barrel Syringe Gel; 3ml/5ml/10ml/PROFESSIONAL WHITENING GEL, Professional Whitening Gel, Dual Barrel Gel; Double Barrel Gel; Dual Barrel Syringe Gel Remineralization Gel/Desensitizing Gel/ syringes of gingival barrier Portable Teeth Whitening kit; Teeth Whitening Strips System; Teeth Bleaching Kit, Teeth Whitening Strips Teeth Whitening Gel Strips; Charcoal teeth whitening strips ,Double Elastic Gel Strips; Teeth Whitening Dry Strips teeth whitening powder/activated charcoal teeth whitening power, Teeth whitening foam Teeth Whitening Kit; Teeth Whitening Home Kit; Teeth Whitening System; Smart Teeth whitening kit; V34 Colour Corrector, V34 Colour Corrector Foam Denture Cleansing Tablet Electric Toothbrush, Sonic Toothbrush, Electric Led Toothbrush, Sonic Led Toothbrush cleaning machine,Multifunctional Cleaner Ultrasonic Cleaner face protection cloths Tongue Scraper Cleaner, tongue cleaner , tongue scraper Stop Snoring Chin Strap; Anti Snore Jaw Supporter; Stop Snoring Solution; Anti Snore Belt, Chin Strap Belt

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2024-12-27
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2017-09-07
EIG	Retractor, All Types	Dental	Class 1	872.4565	2017-09-07
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2017-09-07
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2025-08-01
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2022-12-22
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2017-09-06
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2017-09-06
EIE	Dam, Rubber	Dental	Class 1	872.6300	2017-09-07
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2017-09-06
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2017-09-07
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2017-09-07
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2019-05-13
EAJ	Apron, Leaded	Radiology	Class 1	892.6500	2017-09-07
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2017-08-28
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2017-09-07

Official Correspondent

Hongpeng Xie

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Ekong Technology 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013600135. Last updated year: 2026. Please use registration number 3013600135 when referencing this establishment in official correspondence.