Data / Medical devices / China / Shanghai Dental Instrument Factory Co., Ltd.
Shanghai Dental Instrument Factory Co., Ltd.: FDA-registered device maker in Shanghai, China, 2 510(k) clearances
Shanghai Dental Instrument Factory Co., Ltd. is registered with the FDA (registration 3006113289) in Shanghai, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 15, 2006. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006113289
- Address
- 50 Qixin Road, Shanghai, China, 201100
- Owner or operator
- Shanghai Dental Instrument Factory Co., Ltd. (9089400)
- Roles
- Manufacturer
- First device listed
- July 5, 2006
- Registered through
- 2026
- Brand names listed
- CST61, HIGH SPEED TURBINE, SDIF DENTAL CHAIR WI, SDIF DENTAL CHAIRS WITH
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | NRU | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 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 |
|---|---|---|---|---|---|---|
| November 15, 2006 | K063302 | SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES | EIA | Substantially Equivalent | Shanghai Dental Instrument Factory | accessdata.fda.gov |
| October 26, 2006 | K063110 | CST61 HIGH SPEED TURBINE HANDPIECE | EFB | Substantially Equivalent | Shanghai Dental Instrument Factory | accessdata.fda.gov |
Compare with other makers
- All makers of Handpiece, Air-Powered, Dental
- All makers of Chair, Dental, Without Operative Unit
- All makers of Unit, Operative Dental
Updated November 15, 2006. 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.