Topway Dental Laboratory Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 6 device types.
Topway Dental Laboratory Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Articulators, Crown, Preformed and 4 other device types. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | Topway Dental Laboratory Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006973441 |
| FEI number | 3006973441 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市人和口腔技术有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 8th Floor, Building 1, Jinchi Exhibition Innovation Park, No. 59 Haoye Road, Zhancheng Community |
| Postal code | 518103 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | Class 2 | Endosseous Dental Implant Abutment | 2011 | 15 |
| Articulators | Class 1 | Articulators | 2011 | 7 |
| Crown, Preformed | Class 1 | Preformed Crown | 2011 | 23 |
| Restoration, Porcelain | Class N | Preformed Impression Tray, Articulators, Porcelain Fused To Metal Restorations, Preformed Crown, Porcelain Restorations | 2011 | 50 |
| Restoration, Porcelain-Fused-To-Metal | Class N | Porecelain Fused to Metal Restorations | 2011 | 50 |
| Tray, Impression, Preformed | Class 1 | Preformed Impression Tray | 2011 | 73 |
Clearances
No clearance names Topway Dental Laboratory Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K042658 | 2004-10-20 | NHA | Traditional | Nobel Biocare Uas, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Employees | 300+ |
| Factory area | 5,000 square meters |
| Main products | Dental crowns and bridges, Dental implant crowns, Removable dentures, Precision attachments, Digital CAD-CAM crowns |
| Certifications | US FDA Registration, ISO 13485, ISO 9001, China FDA Medical Device Production License, Class II Medical Device Product Registration Certificate |
| Export markets | North America, Europe, Australia, New Zealand, Israel, Brazil |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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