Data / Medical devices / China / Sunrise Dental Laboratory, Ltd.
Sunrise Dental Laboratory, Ltd.: FDA-registered device maker in Kowloon, Hong Kong, China, 1 510(k) clearance
Sunrise Dental Laboratory, Ltd. is registered with the FDA (registration 3005172141) in Kowloon, Hong Kong, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 3, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005172141
- Address
- Rm 05, 11/F., CEO Tower 77 Wing Hong Street, Lai Chi Kok, Kowloon, Hong Kong, China, 518100
- Owner or operator
- SUNRISE DENTAL LABORATORY, LTD. (9073342)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- May 23, 2005
- Registered through
- 2026
- Brand names listed
- Ceramco 3, E-max, Ivoclar Vivadent, P2 POLYETHER, POSTERIOR WITH METAL INSERT#DENTAL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Metal, Base | EJH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Alloy, Other Noble Metal | EJS | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain-Fused-To-Metal | NSO | N | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Teeth, Artificial, Posterior With Metal Insert | ELJ | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| April 3, 2003 | K030318 | P2 POLYETHER | ELW | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Alloy, Other Noble Metal
- All makers of Restoration, Porcelain-Fused-To-Metal
- All makers of Teeth, Artificial, Posterior With Metal Insert
- All makers of Material, Impression
- All makers of Alloy, Metal, Base
Updated April 3, 2003. 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.