Manufacturer registered with FDA
Proxihealthcare
Ulsan, South Korea. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1South Korea
Devices listed with FDA
What Proxihealthcare currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | TROMATZ-B-N, TROMATZ-B-S, P-WAVE-TB-S, PWAVE-TB-MTROMATZ-DC SeriesTROMATZ-GG1TROMATZ-GGC1 Series (Various Models)TROMATZ-PTROMATZ-STROMATZ-S-BTROMATZ-S-MTROMATZ-S-P | 2020 |
| Powered Tongue ScraperQIA · Class 1 | — | Maker | TROMATZ-O | 2022 |
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 |
|---|---|---|
| PROXIHEALTHCAREFDA reg. 3017685521 | Ulsan, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10078256). 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.