FDA Registration
Active
🇨🇳 China
FUZHOU DELPHIN BIO-TECH CO., LTD.
Reg #: 3029507159
·
FEI: 3029507159
·
Expires 2026
Products
18
Proprietary Names
24
Establishment Types
1
Classifications
18
Registration Details
- Registration Name
- FUZHOU DELPHIN BIO-TECH CO., LTD.
- Registration Number
- 3029507159
- FEI Number
- 3029507159
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- A26, Blue Valley Industrial Complex, Mintai (Fuzhou) Blue Economy Industrial Park, Jiangjing Town, Fuqing,
- City
- Fuzhou Fujian
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240810
Owner / Operator
- Firm Name
- Fuzhou Delphin Bio-tech Co., Ltd.
- Operator Number
- 10088965
- Address
- A26, Blue Valley Industrial Complex, Mintai (Fuzhou) Blue Economy Industrial Park, Jiangjing Town, Fuqing
- City
- Fuzhou
- State
- Fujian
- Postal Code
- 360316
- Country
- CN
- Correspondent
- Echo Li
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2023-10-25 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2023-10-25 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2023-10-25 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2023-10-25 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2023-10-25 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2023-10-25 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2023-10-25 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2023-10-25 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2023-10-25 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2023-10-25 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2023-10-25 |
| Mouthguard, Over-The-Counter | OBR | Class U | Unknown | No | 2026-03-20 |
| Floss, Dental | JES | Class 1 | Dental | No | 2023-10-25 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2023-10-25 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2026-02-27 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2023-10-25 |
| Eraser, Dental Stain | MAU | Class 1 | Dental | No | 2023-10-25 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2023-10-25 |
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
Denture box
Dental Guard, Mouth Guard
Teeth wipe, toothbrush
teeth whitening gel, teeth whitening powder, teeth whitening toothpaste, teeth whitening strip
Teeth color corrector gel, teeth whitening pen, teeth whitening kit, teeth whitening foam, teeth whitening liquid,
PurelyWHITE DELUXE Teeth Whitening Kit, PurelyWHITE Whitening Kit refill, MEANSMILE Teeth Whitening Kit
Teeth Remineralizing Gel, Teeth Desensitizing Gel
Cheek retractor
Establishment Types
Manufacture Medical Device