Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027283275

FEI Number

3027283275

Entity Name

LENA KO CORPORATION

City/State/Country

Taipei City, TW

Establishment Address

7F, No. 33, Sec. 1, Zhongxiao W. Rd., Taipei City 10041, TW

Establishment Type(s)

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

Owner / Operator

Lena Ko Corporation (Owner Number: 10087600)

Owner / Operator Contact Address

7F, No. 33, Sec. 1, Zhongxiao W. Rd., Taipei City, TW-TPE 10041, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CVS FLNG CRWN RPR 1CT - 695108 CVS LST FL CR RPR 2CT - 572123 CVS TONGUE BR 2CT - 572131 CVS ADV ANGL FLSPK - 897706 CVS CMFRT FLSPK - 856262 CVS FLSSR MINT - 454376 CVS FINE MNT FLSR - 971455 CVS FLSSR FINE - 454381 CVS WHTNG FLOSSERV - 257711 CVS FLS THREADER 35CT - 976521 CVS ADVCD MNT FLSS - 542218 CVS SENS FLSPK - 978931 CVS SENS FLSRS - 737670 CVS MINT FLSSR - 853023 CVS INTRDNTL TGHT 16CT -933823 CVS INTRDNTL WIDE 16CT - 957833 CVS UT INTRDNTL BR 32CT - 227508 CVS INTRDNTL MOD 16CT - 214205 CVS INTRDNTL TB 16CT - 469136

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2023-03-18
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2023-03-18
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2023-03-18
JES	Floss, Dental	Dental	Class 1	872.6390	2023-03-18
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2023-03-18

Official Correspondent

Jane Chu

US Agent Details

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

Related Public Records

Same Entity

Lena Ko Corporation

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
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Similar Registrations

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3030268763	OWL DENTAL	San Leandro, CA, US
3029913483	DIMEDI KOREA INC	Busan, KR
1719513	MEDTECH PRODUCTS, INC.	Tarrytown, NY, US
3015525101	MIDWEST TEK	New Albany, IN, US
1825660	RANIR LLC	Grand Rapids, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027283275. Last updated year: 2026. Please use registration number 3027283275 when referencing this establishment in official correspondence.