Manufacturer registered with FDA
Monde Dental Lab
Shenzhen, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Monde Dental Lab currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | M crown | 2013 |
| Preformed CrownELZ · Class 1 | — | Maker | Porcelain crown | 2012 |
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
Monde Dental Lab 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: Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 6 Jul 2009 | K090434 | BECE PRESS | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MONDE DENTAL LABFDA reg. 3009312656 | Shenzhen Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10037856). 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.