Data / Medical devices / China / Xiao Fei Dental Manufacture (Chengdu) Co.Ltd
Xiao Fei Dental Manufacture (Chengdu) Co.Ltd: FDA-registered device maker in CHENGDU Sichuan, China, 3 510(k) clearances
Xiao Fei Dental Manufacture (Chengdu) Co.Ltd is registered with the FDA (registration 3005895657) in CHENGDU Sichuan, China. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 28, 1982. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005895657
- Address
- High-Tech Incubation Area No. 88 Ke Yuan South Rd, B1-202, CHENGDU Sichuan, China, 610041
- Owner or operator
- CHINA DENTAL OUTSOURCING, INC. (9089984)
- Roles
- Manufacturer, Remanufacturer
- First device listed
- July 20, 2006
- Registered through
- 2026
- Brand names listed
- Cercon Zirconia, DENTURE, DENTURE PREFORMED (PARTIA, EMPRESS CROWN, EMPRESS INLAY/ONLAY, EMPRESS VENEER, PORCELAIN, POSTERIOR WITH METAL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Denture Preformed (Partially Prefabricated Denture) | EKO | 2 | Manufacturer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Remanufacturer | accessdata.fda.gov |
| Teeth, Artificial, Backing And Facing | ELK | 1 | Manufacturer | accessdata.fda.gov |
| Teeth, Artificial, Posterior With Metal Insert | ELJ | 1 | Manufacturer | accessdata.fda.gov |
| Teeth, Porcelain | ELL | 2 | 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 28, 1982 | K823744 | PORCELAIN ARTIFICIAL TEETH | ELL | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| January 4, 1980 | K792245 | TEETH, DENTURE, PLASTIC | ELM | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| October 15, 1976 | K760768 | FLEXIDENT DENTURE | EKO | Substantially Equivalent | Flexodent Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Teeth, Artificial, Backing And Facing
- All makers of Denture, Plastic, Teeth
- All makers of Teeth, Porcelain
- All makers of Denture Preformed (Partially Prefabricated Denture)
- All makers of Teeth, Artificial, Posterior With Metal Insert
Updated December 28, 1982. 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.