Foshan Gladent Medical Instrument Co., Ltd.
Registered establishment in Foshan, Guangdong, China. 6 device types.
Foshan Gladent Medical Instrument Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Needle, Dental, Unit, Operative Dental and 4 other device types. Its earliest product listing with the FDA dates from 2017.
Registration
| Registered name | FOSHAN GLADENT MEDICAL INSTRUMENT CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013237609 |
| FEI number | 3013237609 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 佛山市南海格徕德医疗器械有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Foshan |
|---|---|
| Province | Guangdong |
| Address | Room 201, 301, 401, Building 2, Wanyang Kexing Park,No.84, Taoyuan East Road, Shishan Town |
| Postal code | 528000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cabinet, Table And Tray, Anesthesia | Class 1 | Dental cabinet, table and tray | 2026 | 22 |
| Chair, Dental, With Operative Unit | Class 1 | Dental Chair With Operative Unit | 2017 | 4 |
| Needle, Dental | Class 1 | NEEDLE, DENTAL-Dental Burs | 2026 | 56 |
| Unit, Operative Dental | Class 1 | Dental Unit | 2017 | 13 |
| Unit, Operative Dental, Accessories | Class 1 | Dental Intraoral camera and Dental air compressor | 2026 | 65 |
| Unit, Suction Operatory | Class 1 | 2020 | 23 |
Clearances
No clearance names Foshan Gladent Medical Instrument Co., Ltd. as applicant. 2 are held by other companies 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 |
|---|---|---|---|---|
| K071353 | 2007-12-14 | KLC | Traditional | Shanghai Foshion Medical Instruments Co., Ltd. |
| K063302 | 2006-11-15 | EIA | Traditional | Shanghai Dental Instrument Factory Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Main products | dental units, dental handpieces, dental oil-free air compressors, dental suction, curing lights |
| Certifications | TUV CE, ISO 13485, FDA |
| Export markets | European, Middle East, USA, Australia, Latin America (50+ countries) |
Nearby Manufacturers
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.