Data / Medical devices / China / Fuzhou Delphin Bio-Tech Co., Ltd.

Fuzhou Delphin Bio-Tech Co., Ltd.: FDA-registered device maker in Fuzhou Fujian, China, 1 510(k) clearance

Name: Fuzhou Delphin Bio-Tech Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Fuzhou Delphin Bio-Tech Co., Ltd. is registered with the FDA (registration 3029507159) in Fuzhou Fujian, China. It lists 18 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 24, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3029507159
Address: A26, Blue Valley Industrial Complex, Mintai (Fuzhou) Blue Economy Industrial Park, Jiangjing Town, Fuqing, Fuzhou Fujian, China, 360316
Owner or operator: Fuzhou Delphin Bio-tech Co., Ltd. (10088965)
Roles: Manufacturer
First device listed: October 25, 2023
Registered through: 2026
Brand names listed: Cheek retractor, Cotton rolls, Cotton swab, DSI Prophy Laxis Mouth Tray, DSI Prophy Laxis Teeth Whitening Powder, DSI Teeth Whitening Strips, DSI Toothpaste, Dental Guard, Mouth Guard, DSI Mouth Tray, DSI Prophy Laxis Mouth Tray, Dental bib, Dental floss and more

Devices it lists

Device	Product code	Class	Role	Source
Absorber, Saliva, Paper	KHR	1	Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Manufacturer	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Manufacturer	accessdata.fda.gov
Cotton, Roll	EFN	1	Manufacturer	accessdata.fda.gov
Dam, Rubber	EIE	1	Manufacturer	accessdata.fda.gov
Denture, Plastic, Teeth	ELM	2	Manufacturer	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Manufacturer	accessdata.fda.gov
Eraser, Dental Stain	MAU	1	Manufacturer	accessdata.fda.gov
Floss, Dental	JES	1	Manufacturer	accessdata.fda.gov
Heat Source For Bleaching Teeth	EEG	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Mouthguard, Over-The-Counter	OBR	U	Manufacturer	accessdata.fda.gov
Protector, Dental	BRW	1	Manufacturer	accessdata.fda.gov
Retractor, All Types	EIG	1	Manufacturer	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Manufacturer	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	Manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 24, 2024	K240810	Anti Grinding Guard	OBR	Substantially Equivalent	Xiamen Yizhou Imp. & Exp. Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 24, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.