Manufacturer registered with FDA
Topway Dental Laboratory Co., Ltd
Shenzhen, China. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Topway Dental Laboratory Co., Ltd 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 | Topway Dental Laboratory Co., Ltd | 4 device types | — | Below |
| Israel | AMAR | Manufacturer | Topway Dental LaboratoryTopway Dental Laboratory Co., Ltd | 2 | — | 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 Topway Dental Laboratory Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Preformed Impression Tray | 2011 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | Articulators | 2011 |
| Preformed CrownELZ · Class 1 | — | Maker | Preformed Crown | 2011 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Endosseous Dental Implant Abutment | 2011 |
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
Topway Dental Laboratory Co., Ltd 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: Nobel Biocare Uas, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Oct 2004 | K042658 | PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 | Nobel Biocare Uas, Inc. | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Topway Dental Laboratory Co., LtdFDA reg. 3006973441 | Shenzhen Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10036623). 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.