Manufacturer registered with FDA
Amsusa
Atlanta, GA, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Amsusa currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | ECLIPSEECLIPSE 1ECLIPSE 2ECLIPSE 2 PLUSECLIPSE Coloring LiquidECLIPSE KISSECLIPSE KISS PLUSECLIPSE KISS ZirconiaECLIPSE Multi LayerKISS Coloring Liquid | 2018 |
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
Amsusa 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: Ams (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AMSUSA LLCFDA reg. 3014945384 | Atlanta, GA, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058826). 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.