Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013428189

FEI Number

3013428189

Entity Name

SHENZHEN TOPINNOR TECHNOLOGY CO.,LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

No.408 ShenZhen University-Town Park,LiShan Road,NanShan District,ShenZhen, China, Shenzhen Guangdong 518055, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHENZHEN TOPINNOR TECHNOLOGY CO.,LTD (Owner Number: 10093269)

Owner / Operator Contact Address

No.408 ShenZhen University-Town Park,LiShan Road,NanShan District,ShenZhen, China, Shenzhen, CN-GD 518055, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Water Flosser, model: PB01,PB02,PB03,PB04,PB05,PB06,PB07,PB08,PB09,PB10 Water Flosser, model: HO01,HO02,HO03,HO04,HO05,HO06,HO07,HO08,HO09,HO10 Water Flosser, model: DT01,DT02,DT03,DT04,DT05,DT06,DT07,DT08,DT09,DT10 Water Flosser, model: PT01,PT02,PT03,PT04,PT05,PT06,PT07,PT08,PT09,PT10 Dental base; Model: DB-01; DB-02 Dentist Tools, model: D1,D2,D3,D4,D5,D6 Toothbrush, Manual model:A1,A2,A3,A4,A5,A6

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2025-04-22
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2025-12-18
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2025-04-22
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2025-04-22

Official Correspondent

Daniel Wang

US Agent Details

Andy Smith Email: info@grzan-ar.com Phone: (332) 2015192

Related Public Records

Same Entity

SHENZHEN TOPINNOR 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
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Similar Registrations

Registration Number	Establishment Name	Location
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 3013428189. Last updated year: 2026. Please use registration number 3013428189 when referencing this establishment in official correspondence.