Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012896103

FEI Number

3012896103

Entity Name

SHENZHEN BALINDA TECHNOLOGY CO.,LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Second Floor, Building K, Yuanling Industrial Park, Zhixuanhan, Shangwu Community, Shiyan Street, Shenzhen Guangdong 518125, CN

Establishment Type(s)

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

Owner / Operator

Shenzhen Balinda Technology Co.,Ltd (Owner Number: 10056420)

Owner / Operator Contact Address

Second Floor, Building K, Yuanling Industrial Park, Zhixuanhan, Shangwu Community, Shiyan Street, Shenzhen, CN-GD 518125, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nasal Syringe,Ear Syringe,JJ Care Ear Irrigation Kit Denture Cleaning Tablet, Denture Cleanser Nasal Spray Facial Cleaning Brush Comedo Blackhead Remover Massage Brush Aligner Retainer Case/Dental Retainer Case/Orthodontic Mouthguard Case/ Denture Retainer Box Stethoscope Teeth Whitening Powder/Teeth whitening foam Teeth Whitening Kit/Teeth Whitening Pen/Teeth Whitening Gel//Teeth Whitening Strips Ear Wax Removal kit/ Ear Cleaner Dental Floss Nasal Aspirator Oral Irrigator Nozzle Tips for water flosser Nasal Irrigator Toothbrush Sterilizer/Toothbrush Sanitizer/UV Sanitizer For Toothbrushes Dental Scaler/Tartar Remover/Plaque Remover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2022-07-03
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2024-12-19
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2023-12-25
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2018-09-25
ILW	Adaptor, Grooming	Physical Medicine	Class 1	890.5050	2017-12-07
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2018-09-25
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2024-12-19
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2018-09-25
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2021-12-23
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2021-12-23
JES	Floss, Dental	Dental	Class 1	872.6390	2018-09-25
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2021-12-23
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2017-12-07
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2018-09-25
NOB	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	Dental	Class 1	872.6855	2023-12-25
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2023-12-25

Official Correspondent

Bruce Fu

US Agent Details

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

Related Public Records

Same Entity

Shenzhen Balinda 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
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012896103. Last updated year: 2026. Please use registration number 3012896103 when referencing this establishment in official correspondence.