Data / Medical devices / China / Royal Dental Lab
Royal Dental Lab: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Royal Dental Lab is registered with the FDA (registration 3004086183) in Shenzhen Guangdong, China. It lists 12 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 8, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004086183
- Address
- F/1, 2, 3, 5, 6, Building 2, No. 4 West Area Shangxue Industry Park, Bantian, Longgang, Shenzhen Guangdong, China, 518129
- Owner or operator
- ROYAL DENTAL LABORATORY (9057339)
- Roles
- Manufacturer
- First device listed
- July 10, 2003
- Registered through
- 2026
- Brand names listed
- Acrylic Partial, All Ceramic Restoration, CROWN, PREFORMED, Cast Partial, Clear Aligner, Customized Orthodontic Appliance/Device, Dentures, full, Full Metal Crown/Bridge/Inlay/Onlay with Non-Precious Alloy and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Manufacturer | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Manufacturer | accessdata.fda.gov |
| Dentures, Full | NSL | N | Manufacturer | accessdata.fda.gov |
| Dentures, Partial | NSK | N | Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Orthodontic | NSR | N | Manufacturer | accessdata.fda.gov |
| Restoration, Base Metal | NSQ | N | Manufacturer | accessdata.fda.gov |
| Restoration, Noble Metal | NSJ | N | Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain | NSP | N | Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain-Fused-To-Metal | NSO | N | Manufacturer | accessdata.fda.gov |
| Restoration, Resin, Crown And Bridge | NSN | N | Manufacturer | accessdata.fda.gov |
| Teeth, Artificial, Backing And Facing | ELK | 1 | 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 |
|---|---|---|---|---|---|---|
| January 8, 2020 | K192767 | Clear Aligner | NXC | Substantially Equivalent | Royal Dental Lab | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Orthodontic
- All makers of Restoration, Porcelain
- All makers of Dentures, Full
- All makers of Dentures, Partial
- All makers of Aligner, Sequential
- All makers of Restoration, Resin, Crown And Bridge
Updated January 8, 2020. 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.