Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005816808

FEI Number

3005816808

Entity Name

Shummi Enterprise Co., Ltd.

City/State/Country

Taipei, TW

Establishment Address

13F-1, No. 188 Nanking E Road, Sec. 5, Taipei 105, Taiwan, R.O.C., Taipei 105, TW

Establishment Type(s)

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

Owner / Operator

Shummi Enterprise Co, Ltd (Owner Number: 9007361)

Owner / Operator Contact Address

13F-1 No. 188 Nanking Road Section 5, Taipei 105, TW-TPE 105, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Comfort Picks Metal Tongue Scraper ENFRESH ORIGINAL TONGUE BRUSH Applicator, Butt Brush MOUTH DENTAL Explorer MANUAL TOOTHBRUSH Pre-pasted toothbrush DENTAL WAX Super Dental Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JET	Pick, Massaging	Dental	Class 1	872.6650	2017-08-08
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2007-03-06
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2022-08-02
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2007-03-06
EKB	Explorer, Operative	Dental	Class 1	872.4565	2011-01-26
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2007-03-06
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2007-03-22
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2012-07-03

Official Correspondent

No official correspondent registered.

US Agent Details

A.W. Gebhard Business: LUCKY CHIN INC. Email: luckychin@att.net Phone: (303) 7771819

Related Public Records

Same Entity

Shummi Enterprise Co, Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006536571	SHUMEI INDUSTRIAL (HEBEI) CO., LTD.	CHANG ZHOU CITY Hebei, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Similar Registrations

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3011089435	Allmed Industrial Limited	Shenzhen City Guangdong, CN
9710299	ACUMEN HOUSEWARE INDUSTRY (NANNING) CO., LTD.	NANNING Guangxi, CN
3009171220	DENTIMED SAO JOAO	Sunrise, FL, US
3001655856	VAGO INTERNATIONAL MANUFACTURING SA DE CV	Monterrey Nuevo Leon, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005816808. Last updated year: 2026. Please use registration number 3005816808 when referencing this establishment in official correspondence.