Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008262609

FEI Number

3008262609

Entity Name

PESITRO HEALTHCARE PRODUCTS CO., LTD.

City/State/Country

Yangzhou Jiangsu, CN

Establishment Address

No.16 Huai Jiang Road, Hangji town, Yangzhou Jiangsu 225111, CN

Establishment Type(s)

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

Owner / Operator

Pesitro Healthcare Products Co., Ltd. (Owner Number: 10031762)

Owner / Operator Contact Address

No.16 Huai Jiang Road, HangJi town, Yangzhou, CN-JS 225111, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Flosser: Ultrahigh molecular weight polyethylene (UHMWPE) Handle: PP Orthodontic 2x Clean twin-line Floss Picks;YANDY;50 COUNTS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JES	Floss, Dental	Dental	Class 1	872.6390	2010-03-05
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2010-03-05
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2019-12-26
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2019-12-26

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008262609. Last updated year: 2026. Please use registration number 3008262609 when referencing this establishment in official correspondence.