Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027344647

FEI Number

3027344647

Entity Name

KLATER (HONGKONG) INTERNATIONAL LIMITED

City/State/Country

Hong Kong, CN

Establishment Address

Room FLAT/RM B 5/F GAYLORD COMMERCIAL BUILDING 114-118 LOCKHART ROAD, Hong Kong 999077, CN

Establishment Type(s)

Foreign Private Label Distributor,Manufacture Medical Device

Owner / Operator

KLATER (HONGKONG) INTERNATIONAL LIMITED (Owner Number: 10087804)

Owner / Operator Contact Address

Room FLAT/RM B 5/F GAYLORD COMMERCIAL BUILDING 114-118 LOCKHART ROAD, Hong Kong, CN-NOTA 999077, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2023-04-11
JES	Floss, Dental	Dental	Class 1	872.6390	2023-04-11
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2023-04-11

Official Correspondent

Xiaojun Zeng

US Agent Details

Sebastian Feye Business: Accurate Consultants Inc Email: Sebastian@Accuratefdaconsulting.Com Phone: (619) 5170673

Related Public Records

Same Entity

KLATER (HONGKONG) INTERNATIONAL 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
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

Similar Registrations

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3013353014	H2OFLOSS.INC	Ozone Park, NY, US
3025436467	GAVIN BIOTECHNOLOGY CO.,LTD	Jinzhong Shanxi, CN
3006572778	IN'TECH INDUSTRIES	Ramsey, MN, US
3005607635	HI-P (XIAMEN) PRECISION PLASTIC MANUFACTURING CO.,	XIAMEN Fujian, CN
3010162782	PROVIDENCE ENTERPRISE LIMITED	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027344647. Last updated year: 2026. Please use registration number 3027344647 when referencing this establishment in official correspondence.