Registered with FDA
SR China
Shaoxing City, China. Lists 1 dental device type with FDA across 0 registered establishments.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 0—
Devices listed with FDA
What SR China currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | GRADIA PREMi | 2026 |
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
SR China 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: GC America Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Jun 2026 | K261246 | SRGC-06 | GC America Inc. | EBF Resin Tooth Shade Material |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10096352). 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.