Fuzhou Delphin BIO-Tech Co., Ltd.
Registered establishment in Fuzhou, Fujian, China. 18 device types.
Fuzhou Delphin BIO-Tech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Dam, Rubber, Cotton, Roll and 16 other device types. Its earliest product listing with the FDA dates from 2023.
Registration
| Registered name | FUZHOU DELPHIN BIO-TECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3029507159 |
| FEI number | 3029507159 |
| Establishment type | Manufacturer |
Location
| City | Fuzhou |
|---|---|
| Province | Fujian |
| Address | A26, Blue Valley Industrial Complex, Mintai (Fuzhou) Blue Economy Industrial Park, Jiangjing Town, Fuqing, |
| Postal code | 360316 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | Dental bib | 2023 | 86 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | VE swab | 2023 | 186 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Cotton swab | 2023 | 100 |
| Cleanser, Denture, Over The Counter | Class 1 | mouthwash tablets, Oil Pulling, Cleaning Crystals, Toothpaste Tablet, DSI Oil Pulling, Mouthwash, mouth spray, denture cleansing tablets, mouth tray cleaner, aligner cleaner, cleaning tablets, | 2023 | 34 |
| Cotton, Roll | Class 1 | Cotton rolls | 2023 | 107 |
| Dam, Rubber | Class 1 | Gum protector gel | 2023 | 23 |
| Denture, Plastic, Teeth | Class 2 | Teeth shade guide | 2023 | 26 |
| Disinfectant, Medical Devices | Class 1 | Hand sanitizer | 2023 | 197 |
| Eraser, Dental Stain | Class 1 | DSI Prophy Laxis Teeth Whitening Powder, DSI Teeth Whitening Strips, DSI Toothpaste, 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, DSI Prophy Laxis Paste | 2023 | 33 |
| Floss, Dental | Class 1 | Dental floss | 2023 | 151 |
| Heat Source For Bleaching Teeth | Class 1 | Teeth whitening light | 2023 | 56 |
| Instrument, Manual, Surgical, General Use | Class 1 | Denture box | 2023 | 110 |
| Mouthguard, Over-The-Counter | Class U | Thermo-forming Dental Guard, Anti Grinding Guard; Anti Grinding and Anti Snoring Guard, ClenchNoMore;, DSI Prophy Laxis Mouth Tray, TheSleepGuard, Orthodontic Mouth Guard, Mouth guard for teeth whitening treatment, DSI Mouth Tray, Mouth Guard, Dental Guard, Mouth Tray, Dental Tray, Nightguard, Thermo-forming moldable Mouth Guard, | 2026 | 4 |
| Protector, Dental | Class 1 | Dental Guard, Mouth Guard, DSI Mouth Tray, DSI Prophy Laxis Mouth Tray | 2026 | 11 |
| Retractor, All Types | Class 1 | Cheek retractor | 2023 | 45 |
| Toothbrush, Manual | Class 1 | Teeth wipe, toothbrush | 2023 | 244 |
| Toothbrush, Powered | Class 1 | Electric toothbrush | 2023 | 191 |
| Tray, Impression, Preformed | Class 1 | DSI Prophy Laxis Mouth Tray, Dental mouthpiece, teeth whitening tray, anti-snore mouth guard, anti-grinding mouth guard, DSI Mouth Tray | 2023 | 73 |
Clearances
No clearance names Fuzhou Delphin BIO-Tech Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240810 | 2024-05-24 | OBR | Traditional | Xiamen Yizhou IMP. & EXP. Co., Ltd. |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Fuzhou Feiwo Trading Co., Ltd. | 11 |
| Jiangxi Aicare Medical Technology Co., Ltd. | 8 |
| Fuzhoushi Cangshanqu Linke Maoyiyouxiangongsi | 4 |
| Fuzhou Rick Brown Biomaterials Co., Ltd. | 3 |
| Fuzhou Maixin Biotech Co., Ltd. | 3 |
| Fuzhou Xiaoyi Electronics Co., Ltd. | 2 |
| Fujian Guozi Rehabilitation Medical Co., Ltd. | 2 |
| Jiangxi Baoeran Biomedical Science & Technology Co., Ltd. | 1 |
| Fuzhou Fushunying Sports Goods Co., Ltd. | 1 |
| Fujian Yitaikang Electronics Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.