Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029507159

FEI Number

3029507159

Entity Name

FUZHOU DELPHIN BIO-TECH CO., LTD.

City/State/Country

Fuzhou Fujian, CN

Establishment Address

A26, Blue Valley Industrial Complex, Mintai (Fuzhou) Blue Economy Industrial Park, Jiangjing Town, Fuqing,, Fuzhou Fujian 360316, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fuzhou Delphin Bio-tech Co., Ltd. (Owner Number: 10088965)

Owner / Operator Contact Address

A26, Blue Valley Industrial Complex, Mintai (Fuzhou) Blue Economy Industrial Park, Jiangjing Town, Fuqing, Fuzhou, CN-FJ 360316, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental bib Hand sanitizer Electric toothbrush Dental mouthpiece, teeth whitening tray, anti-snore mouth guard, anti-grinding mouth guard Mouthwash, mouth spray, denture cleansing tablets, mouth tray cleaner, aligner cleaner, cleaning tablets, mouthwash tablets, Oil Pulling, Cleaning Crystals, Toothpaste Tablet Teeth shade guide Cotton rolls Gum protector gel Teeth whitening light Cotton swab VE swab Mouth Guard, Dental Guard, Mouth Tray, Dental Tray, Nightguard, Thermo-forming moldable Mouth Guard, TheSleepGuard, Orthodontic Mouth Guard, Mouth guard for teeth whitening treatment Thermo-forming Dental Guard, Anti Grinding Guard; Anti Grinding and Anti Snoring Guard, ClenchNoMore; Dental floss

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2023-10-25
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2023-10-25
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2023-10-25
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2023-10-25
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2023-10-25
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2023-10-25
EFN	Cotton, Roll	Dental	Class 1	872.6050	2023-10-25
EIE	Dam, Rubber	Dental	Class 1	872.6300	2023-10-25
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2023-10-25
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2023-10-25
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2023-10-25
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2026-03-20
JES	Floss, Dental	Dental	Class 1	872.6390	2023-10-25

Official Correspondent

Echo Li

US Agent Details

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

Related Public Records

Same Entity

Fuzhou Delphin Bio-tech 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
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029507159. Last updated year: 2026. Please use registration number 3029507159 when referencing this establishment in official correspondence.