Data / Medical devices / China / Topway Dental Laboratory Co., Ltd
Topway Dental Laboratory Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Topway Dental Laboratory Co., Ltd is registered with the FDA (registration 3006973441) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 20, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006973441
- Address
- 8th Floor, Building 1, Jinchi Exhibition Innovation Park, No. 59 Haoye Road, Zhancheng Community Fuhai Street, Baoan District, Shenzhen Guangdong, China, 518103
- Owner or operator
- Topway Dental Laboratory Co., Ltd (10036623)
- Roles
- Manufacturer
- First device listed
- May 18, 2011
- Registered through
- 2026
- Brand names listed
- Articulators, Endosseous Dental Implant Abutment, Porcelain Fused To Metal Restorations, Porcelain Restorations, Porecelain Fused to Metal Restorations, Preformed Crown, Preformed Impression Tray
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Articulators | EJP | 1 | Manufacturer | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain | NSP | N | Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain-Fused-To-Metal | NSO | N | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 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 |
|---|---|---|---|---|---|---|
| October 20, 2004 | K042658 | PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 | NHA | Substantially Equivalent | Nobel Biocare Uas, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Impression, Preformed
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Restoration, Porcelain-Fused-To-Metal
- All makers of Crown, Preformed
- All makers of Articulators
- All makers of Restoration, Porcelain
Updated October 20, 2004. 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.