SHENZHEN BAOTONGHUI INDUSTRIAL CO.,LTD

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3019912897

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3019912897
FEI Number
3019912897
Entity Name
SHENZHEN BAOTONGHUI INDUSTRIAL CO.,LTD
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
501, No. 6-6 Egongling West Road, Liulian, Pingdi, Longgang District, Shenzhen Guangdong 518117, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
SHENZHEN BAOTONGHUI INDUSTRIAL CO.,LTD (Owner Number: 10086151)
Owner / Operator Contact Address
501, No. 6-6 Egongling West Road, Liulian, Pingdi, Longgang District, Shenzhen, CN-GD 518117, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Teeth whitening products Oral care kit Powered toothbrush/Toothbrush head Cotton swabs Tongue scraper Interdental brush, Manual toothbrush/Toothbrush head Orthodontic accessories Water Flosser/Oral Irrigator Dental floss, Dental Floss Pick, Floss threader

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAU Eraser, Dental Stain Dental Class 1 872.6855 2026-04-09
NXZ Dental Hygiene Kit Dental Class 1 872.6855 2026-04-09
JEQ Toothbrush, Powered Dental Class 1 872.6865 2026-04-09
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2026-04-09
LCN Scraper, Tongue Dental Class 1 872.6855 2022-10-18
EFW Toothbrush, Manual Dental Class 1 872.6855 2022-10-18
DYJ Retainer, Screw Expansion, Orthodontic Dental Class 1 872.5410 2022-10-18
EFS Unit, Oral Irrigation Dental Class 1 872.6510 2026-04-09
JES Floss, Dental Dental Class 1 872.6390 2022-10-18

Official Correspondent

LIMIN LEI

US Agent Details

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

Related Public Records

Same Entity

SHENZHEN BAOTONGHUI INDUSTRIAL 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
K973236 Procter & Gamble Co. CREST TOOTHBRUSH WITH MICROSHIELD 1998-03-11
K844318 Pro Pulse, Inc. ORAL IRRIGATION TIP 1984-11-23
K882164 Arthur Blank & Co., Inc. FLOSS CARD 1988-06-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019912897. Last updated year: 2026. Please use registration number 3019912897 when referencing this establishment in official correspondence.
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