Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011545201

FEI Number

3011545201

Entity Name

KI. WORKS VIETNAM CO., LTD

City/State/Country

Mongkok, Kln., Hong Kong, HK

Establishment Address

Rm. 1702, Sino Centre, 582-592 Nathan Rd, Mongkok, Kln., Hong Kong NA, HK

Establishment Type(s)

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

Owner / Operator

Ki. WORKS VIETNAM CO., LTD (Owner Number: 10048361)

Owner / Operator Contact Address

Rm. 1702, Sino Centre, 582-592 Nathan Rd, Mongkok, Kln., Hong Kong, HK-NOTA 000000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123849

PMA Number

N/A

All Registered Proprietary Names

REACH Professional Floss Picks 90 REACH Professional Floss Picks Mint 3CT REACH Professional Floss Picks Mint 2CT REACH Professional Comfy Picks 60

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2015-01-05
JET	Pick, Massaging	Dental	Class 1	872.6650	2015-01-05
JES	Floss, Dental	Dental	Class 1	872.6390	2015-01-05
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2021-12-17

Official Correspondent

Donald Lin

US Agent Details

Ken Grant Business: Compliance Engineering, Inc. Email: kgrant@compliance-engineer.com Phone: (516) 9847287

Related Public Records

Same Entity

Ki. WORKS VIETNAM 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
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

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3040335058	INDIVATION EXPORTS PRIVATE LIMITED	Gurugram Haryana, IN
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3018507299	NAM HA VIET NAM TRADING COMPANY LIMITED	Hanoi Ha Noi, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011545201. Last updated year: 2026. Please use registration number 3011545201 when referencing this establishment in official correspondence.