Manufacturer registered with FDA
Dome Inc.
Tarzana, CA, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Dome Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Dome abrasive | 2013 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Coronado | 2013 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Dome Innovation Chair | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DOME INCFDA reg. 3001166318 | Tarzana, CA, United States | Manufacturer, Remanufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043260). 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.