Manufacturer registered with FDA
PHS Do Brasil LTDA
Joinville, Brazil. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 5119 registrations outside the US
- Establishments
- 1Brazil
Registered in 5 markets
Where regulators' registries name PHS Do Brasil LTDA as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | PHS Do Brasil LTDA | 5 device types | — | Below |
| Brazil | ANVISA | Registration holder | PHS DO BRASIL LTDA | 69 | 2016–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | PHS DO BRASIL LTDA | 26 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | PHS DO BRASIL LTDA | 13 | 2022–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | PHS DO BRASIL LTDA | 11 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What PHS Do Brasil LTDA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | POTENZA CLOUD CLEAN | 2026 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | POTENZA FINEX CUTPOTENZA FINEX DISCPOTENZA FINEX MANDREL | 2026 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | POTENZA BLOCCO | 2026 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | POTENZA ABRASIONEPOTENZA SPECCHI ALPOTENZA SPECCHI AL UNO DUEPOTENZA SPECCHI ARGILLA PROPOTENZA SPECCHI PRO | 2022 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | POTENZA STAMPO EVA | 2026 |
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 |
|---|---|---|
| PHS DO BRASIL LTDAFDA reg. 3022112716 | Joinville Santa Catarina, Brazil | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084634). 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.