Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038191347

FEI Number

3038191347

Entity Name

ANQING CLEAN DENTAL INSTRUMENT TECHNOLOGY CO.,LTD

City/State/Country

Anqing City Anhui, CN

Establishment Address

NO,1 WUXIANG ROAD,YIXIU DISTRICT, Anqing City Anhui 246000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ANQING CLEAN DENTAL INSTRUMENT TECHNOLOGY CO.,LTD (Owner Number: 10092960)

Owner / Operator Contact Address

NO,1 WUXIANG ROAD,YIXIU DISTRICT, Anqing City, CN-AH 246000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Flat Sterilization Reel Flat Sterilization Roll Sterilization Package/Reel Tyvek Sterilization Roll&Pouch Self Sealing Sterilization Pouch Self-sealing Sterilization Pouch Gusseted Sterilization Reel Gusseted sterilized paper bag Gusseted Sterilization Roll Dental bib Saliva ejector non-woven fabric Crepe Paper MICRO APPLICATOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-03-10
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2025-03-10
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2026-06-21
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2026-06-03
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2025-07-23
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2026-06-03

Official Correspondent

ALEX WU

US Agent Details

Hui Hong Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

ANQING CLEAN DENTAL INSTRUMENT 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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

Registration Number	Establishment Name	Location
2523664	M & Q PACKAGING LLC	SCHUYLKILL HAVEN, PA, US
9680031	STEPAC L.A., LTD.	TEFEN, WESTERN GALILEE Northern, IL
9616096	La Ada de Acuna	CIUDAD DE ACUNA Coahuila, MX
1054380	Halyard North Carolina, LLC	LINWOOD, NC, US
8030674	ESPECIALISTAS EN ESTERILIZACION Y ENVASE, S. A. DE C. V.	Tlalnepantla, Estado de Mexico, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038191347. Last updated year: 2026. Please use registration number 3038191347 when referencing this establishment in official correspondence.