Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027257639

FEI Number

3027257639

Entity Name

YANGJIANG KAIMI IMPORT EXPORT CO.,LTD

City/State/Country

Yangjiang Guangdong, CN

Establishment Address

2nd Floor,No. 17,10th Yongxing Road,Dongcheng Town,Yangdong,Yangjiang,China 529931, Yangjiang Guangdong 529500, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Yangjiang Kaimi Import Export Co.,Ltd (Owner Number: 10089443)

Owner / Operator Contact Address

2nd Floor,No. 17,10th Yongxing Road,Dongcheng Town,Yangdong,Yangjiang,China 529931, Yangjiang, CN-GD 529500, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BAND, MATERIAL, ORTHODONTIC MIRROR, MOUTH SCALER, PERIODONTIC FLOSS, DENTAL tongue scraper Bulb, inflation, for endoscope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2024-12-01
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2024-12-01
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2024-12-01
JES	Floss, Dental	Dental	Class 1	872.6390	2024-12-01
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2023-12-07
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2024-12-01

Official Correspondent

Sophy Poon

US Agent Details

mark DU Email: markFDA@outlook.com Phone: (303) 7319873

Related Public Records

Same Entity

Yangjiang Kaimi Import Export 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
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

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2126683	AMERICAN ORTHODONTICS	SHEBOYGAN, WI, US
3006946041	OSSTEM ORTHODONTICS Inc.	Uiwang-si Gyeonggi, KR
3026326493	ZHEJIANG YAMEI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.	Yang Jiao Lang Zin'an Town Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027257639. Last updated year: 2026. Please use registration number 3027257639 when referencing this establishment in official correspondence.