Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008648418

FEI Number

3008648418

Entity Name

ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY CO., LTD.

City/State/Country

Zhengzhou Henan, CN

Establishment Address

Room 301, 3rd Floor, Building 2, No. 52, Hongsong Road, High-tech Industrial Development Zone, Zhengzhou Henan 450001, CN

Establishment Type(s)

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

Owner / Operator

Zhengzhou Huaer Electro-optics Technology Co., Ltd. (Owner Number: 10040158)

Owner / Operator Contact Address

Room 301, 3rd Floor, Building 2, No. 52, Hongsong Road, High-tech Industrial Development Zone, Zhengzhou, CN-HA 450001, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Intra Oral Camera Micro needling therapy system Teeth Cleaning Kit Electric toothbrush Cleanser, Denture, Denture Cleanser, denture cleaning tablets water flosser Heat Source for Bleaching Teeth Teeth Whitening lamp/Machine/Light Mouth tray box ultrasonic cleaner Chewies Vacuum Forming Material, Pro Guard Mouthguard Material, Pro-form Vacuum Forming Material, Pro- Tray Custom Material Ortho Model Resin 3D printing Resin Water-Washable Ortho Model Resin resin material BlanQuest Home Whitening Kit GB-HOM101 Gingival barrier/Gum protector Mouth Tray teeth whitening essence,teeth whitening serum, Teeth whitening gel, dual barrel syringe gel, professional whitening gel, Coconut oil teeth whitening pulling, bamboo toothbrushes, teeth whitening strips, desentitization gel, remineralization gel, oral spray, mouth trays, teeth cleaning and whitening foam, teeth whitening foam toothpaste, Teeth whitening kit, teeth whitening home kit, teeth whitening system, teeth bleaching system, teeth bleaching kit, Teeth whitening powder, Teeth whitening strips, Teeth whitening pen, bleaching pen, teeth whitener, Charcoal Teeth Whitening Powder, Charcoal teeth whitening strips, charcoal foam toothpaste, gingival barriel, gum protector teeth whitening toner GloboDent Whitening Accelerator GB-GWA101 LuxBrite Personal Teeth Whitening System GB-LB101 LuxBrite Refill Kit GB-LX105 BlanQuest Pro Professional Whitening Treatment Kit GB-PRO101 Luxsmile/Selvra Teeth whitening liquid HR-BSG01 Oxygen Dome Facial Machine Preformed impression tray, Plastic impression tray, impression tray Toothbrush Cheek Retractor Red LED Light Therapy Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2022-01-24
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-05-23
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2023-11-24
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2022-11-18
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2021-06-08
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2022-11-18
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2012-03-14
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2019-11-03
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2022-11-29
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2024-10-20
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2021-07-12
EBE	Coating, Denture Hydrophilic, Resin	Dental	Class 2	872.3300	2022-11-18
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2015-11-25
MNE	Orthosis, Moldable, Supportive, Skin Protective	Physical Medicine	Class 1	890.3475	2022-08-03
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2019-11-03
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2024-02-04
EIG	Retractor, All Types	Dental	Class 1	872.4565	2019-11-03
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2024-01-19

Official Correspondent

Kaihui Wang

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (509) 5816099

Related Public Records

Same Entity

Zhengzhou Huaer Electro-optics Technology 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
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

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 3008648418. Last updated year: 2026. Please use registration number 3008648418 when referencing this establishment in official correspondence.