Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025436467

FEI Number

3025436467

Entity Name

GAVIN BIOTECHNOLOGY CO.,LTD

City/State/Country

Jinzhong Shanxi, CN

Establishment Address

BuildingA15-02, Jinke Wisdom Science &Technology City, Yuci District, Jinzhong Shanxi 030600, CN

Establishment Type(s)

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

Owner / Operator

GAVIN BIOTECHNOLOGY CO.,LTD (Owner Number: 10086568)

Owner / Operator Contact Address

BuildingA15-02, Jinke Wisdom Science &Technology City, Yuci District, Jinzhong, CN-SX 030600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Operating microscope Dental Polishing Motor Ultrasonic Tooth Scaler Dental Polishing Machine sealant root canal sealer Endodontic sealer root canal sealing paste root canal gap-filling sealant root canal gap-sealing paste Curing Light machine Handle files Dental root canal file Endo files Rotary files Accessory Absorbent Paper Points Absorbent Paper Points Root canal sealer Surgical magnifying glass Dental Loupe Endo motor Dental Apex Locator Dental Anti-fog Mirror

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSO	Microscope, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4700	2022-11-20
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2024-09-30
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2024-09-30
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2025-03-09
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2025-07-30
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-09-30
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2022-11-20
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2023-08-09
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2025-07-30
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2024-09-30
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2022-11-20
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2025-03-09
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2025-03-09

Official Correspondent

Feng He

US Agent Details

Wei Huang Email: weihuang1979@gmail.com Phone: (713) 5053208

Related Public Records

Same Entity

GAVIN BIOTECHNOLOGY 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
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06
K933337	R & D Batteries, Inc.	R AND D BATTERY REPLACEMENT	1994-04-05
K873766	Bowen & Company, Inc.	STERNAL POWER AWL	1988-11-14

Similar Registrations

Registration Number	Establishment Name	Location
3014059828	SHANGHAI EDER MEDICAL TECHNOLOGY INC.	Shanghai, CN
3013351723	SHENZHEN VIVOLIGHT MEDICAL DEVICE&TECHNOLOGY CO., LTD.	shenzhen Guangdong, CN
3013154160	Suzhou Semorr Medical Technology Co.,Ltd.	Suzhou Jiangsu, CN
3005527904	ATMOS INC.	Exton, PA, US
3001644167	Symmetry Surgical GmbH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025436467. Last updated year: 2026. Please use registration number 3025436467 when referencing this establishment in official correspondence.