Data / Medical devices / China / Foshan Gladent Medical Instrument Co.,ltd.
Foshan Gladent Medical Instrument Co.,ltd.: FDA-registered device maker in Foshan Guangdong, China, 2 510(k) clearances
Foshan Gladent Medical Instrument Co.,ltd. is registered with the FDA (registration 3013237609) in Foshan Guangdong, China. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 14, 2007. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013237609
- Address
- Room 201, 301, 401, Building 2, Wanyang Kexing Park,No.84, Taoyuan East Road, Shishan Town Nanhai District, Foshan Guangdong, China, 528000
- Owner or operator
- Foshan Gladent Medical Instrument Co.,Ltd. (10055871)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 13, 2017
- Registered through
- 2027
- Brand names listed
- Dental Chair With Operative Unit, Dental Intraoral camera and Dental air compressor, Dental Unit, Dental cabinet, table and tray, NEEDLE, DENTAL-Dental Burs
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cabinet, Table And Tray, Anesthesia | BRY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Chair, Dental, With Operative Unit | KLC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Suction Operatory | EBR | 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 |
|---|---|---|---|---|---|---|
| December 14, 2007 | K071353 | FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C | KLC | Substantially Equivalent | Shanghai Foshion Medical Instruments Co., Ltd. | accessdata.fda.gov |
| November 15, 2006 | K063302 | SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES | EIA | Substantially Equivalent | Shanghai Dental Instrument Factory | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Suction Operatory
- All makers of Chair, Dental, With Operative Unit
- All makers of Cabinet, Table And Tray, Anesthesia
- All makers of Needle, Dental
- All makers of Unit, Operative Dental
- All makers of Unit, Operative Dental, Accessories
Updated December 14, 2007. 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.