Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021245739

FEI Number

3021245739

Entity Name

SHANDONG RICHSOURCE BIOLOGICAL TECHNOLOGY CO.,LTD

City/State/Country

Jining Shandong, CN

Establishment Address

50m to the South of Miaokou Village, Yangdian Town, Wenshang County, Jining Shandong 272500, CN

Establishment Type(s)

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

Owner / Operator

Shandong Richsource Biological Technology Co.,Ltd (Owner Number: 10083252)

Owner / Operator Contact Address

50m to the South of Miaokou Village, Yangdian Town, Wenshang County, Jining, CN-SD 272500, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Water Floss, Water Toothpick Dental Orthodontic Bite Stick, Dental Braces Extractor Ultrasonic Electric Dental Scaler (KWJ-103) Electric Toothbrush Dental Guard Dental Floss Pick, Dental Floss, Bamboo Floss Picks Tongue Scraper Interdental Brush, Toothbrush, Toothpaste Extruder, Bamboo Interdental Brush, Bamboo Toothbrush Soft Pick

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2021-11-05
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2021-11-05
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2026-04-14
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2021-11-05
EKM	Gutta-Percha	Dental	Class 1	872.3850	2023-12-19
JES	Floss, Dental	Dental	Class 1	872.6390	2021-11-05
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2021-11-05
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2021-11-05
JET	Pick, Massaging	Dental	Class 1	872.6650	2021-11-05

Official Correspondent

Cancan Wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shandong Richsource Biological 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
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14

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 3021245739. Last updated year: 2026. Please use registration number 3021245739 when referencing this establishment in official correspondence.