Monde Dental LAB
Registered establishment in Shenzhen, Guangdong, China. 3 device types.
Monde Dental LAB is a manufacturer holding a current FDA establishment registration. The registration covers Crown, Preformed, Powder, Porcelain and 1 other device type. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | MONDE DENTAL LAB |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009312656 |
| FEI number | 3009312656 |
| Establishment type | Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 4Floor,Biguiyuan 28 Cang |
| Postal code | 518102 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Crown, Preformed | Class 1 | Porcelain crown | 2012 | 23 |
| Powder, Porcelain | Class 2 | M crown | 2013 | 33 |
| Restoration, Porcelain-Fused-To-Metal | Class N | Mon Crown | 2011 | 50 |
Clearances
No clearance names Monde Dental LAB 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 |
|---|---|---|---|---|
| K090434 | 2009-07-06 | EIH | Traditional | Bego Bremer Goldschlaegerei Wilh. Herbst Gmbh & Co. KG |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Employees | 20+ |
| Main products | Crowns, Bridges, Dentures, Orthodontic appliances, Zirconia implant bridges |
| Certifications | FDA 3009312656 |
| Export markets | USA, Canada, Europe, Japan |
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.
The manufacturer named here can complete this record.