Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015140246

FEI Number

3015140246

Entity Name

BULETEDAN TECHNOLOGY CO, LTD.

City/State/Country

Yancheng City Jiangsu, CN

Establishment Address

No. 27 Nanying Road, Tinghu Dist., Yancheng City Jiangsu 224001, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Buletedan Technology Co, Ltd. (Owner Number: 10059160)

Owner / Operator Contact Address

No. 27 Nanying Road, Tinghu Dist., Yancheng City, CN-JS 224001, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tongue Scraper Dental Flex Brush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2018-12-06
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2018-12-06

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Randall Business: ComplianceAcuity, Inc. Email: info@complianceacuity.com Phone: (303) 8280844

Related Public Records

Same Entity

Buletedan Technology 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
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

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3015337442	JIANGSU HUANYI INDUSTRIAL CO., LTD.	Suqian Jiangsu, CN
3013972866	ROSEMARIE PRODUCTS COMPANY, LLC	Mason, OH, US
3005816808	Shummi Enterprise Co., Ltd.	Taipei, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015140246. Last updated year: 2026. Please use registration number 3015140246 when referencing this establishment in official correspondence.