Manufacturer registered with FDA
China Dental Outsourcing Inc
CHENGDU, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name China Dental Outsourcing Inc as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | China Dental Outsourcing Inc | 5 device types | — | Below |
| Australia | TGA | Manufacturer | China Dental Outsourcing Inc | 1 | 2023–2023 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What China Dental Outsourcing Inc currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Denture Preformed (Partially Prefabricated Denture)EKO · Class 2 | Denture resins & teeth | Maker | DENTURE PREFORMED (PARTIAValplast | 2007 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Maker | POSTERIOR WITH METAL | 2006 |
| Backing and Facing Artificial TeethELK · Class 1 | — | Maker | Cercon Zirconiae.maxEMPRESS CROWNEMPRESS INLAY/ONLAYEMPRESS VENEER | 2006 |
| Porcelain TeethELL · Class 2 | Dental ceramics & zirconia | Maker | PORCELAIN | 2006 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | DENTURETEETH | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
China Dental Outsourcing Inc lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dentsply Intl., Inc. (2), Flexodent Corp. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Dec 1982 | K823744 | PORCELAIN ARTIFICIAL TEETH | Dentsply Intl., Inc. | ELL Porcelain Teeth |
| 4 Jan 1980 | K792245 | TEETH, DENTURE, PLASTIC | Dentsply Intl., Inc. | ELM Teeth Plastic Denture |
| 15 Oct 1976 | K760768 | FLEXIDENT DENTURE | Flexodent Corp. | EKO Denture Preformed (Partially Prefabricated Denture) |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Xiao Fei Dental Manufacture (Chengdu) Co.LtdFDA reg. 3005895657 | CHENGDU Sichuan, China | Manufacturer, Remanufacturer |
Other names on FDA records
Xiao Fei Dental Manufacture (Chengdu) Co.Ltd
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9089984). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.