Manufacturer registered with FDA
Sunrise Dental Laboratory, Ltd.
Kowloon, Hong Kong SAR China. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Sunrise Dental Laboratory, Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | Ivoclar Vivadent | 2012 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Maker | Ivoclar Vivadent | 2012 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Maker | POSTERIOR WITH METAL INSERT#DENTAL | 2005 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | P2 POLYETHER | 2008 |
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
Sunrise Dental Laboratory, Ltd. 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: Heraeus Kulzer, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 Apr 2003 | K030318 | P2 POLYETHER | Heraeus Kulzer, LLC | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SUNRISE DENTAL LABORATORY, LTD.FDA reg. 3005172141 | Kowloon, Hong Kong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9073342). 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.