Data / Medical devices / China / Monde Dental Lab
Monde Dental Lab: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Monde Dental Lab is registered with the FDA (registration 3009312656) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 6, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009312656
- Address
- 4Floor,Biguiyuan 28 Cang Xixiang, BaoAn, Shenzhen Guangdong, China, 518102
- Owner or operator
- Monde Dental Lab (10037856)
- Roles
- Manufacturer
- First device listed
- August 24, 2011
- Registered through
- 2026
- Brand names listed
- M crown, Mon Crown, Porcelain crown
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown, Preformed | ELZ | 1 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain-Fused-To-Metal | NSO | N | 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 |
|---|---|---|---|---|---|---|
| July 6, 2009 | K090434 | BECE PRESS | EIH | Substantially Equivalent | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | accessdata.fda.gov |
Compare with other makers
- All makers of Crown, Preformed
- All makers of Powder, Porcelain
- All makers of Restoration, Porcelain-Fused-To-Metal
Updated July 6, 2009. 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.