Manufacturer registered with FDA
Andre Gregate Braga Instrumentos Ltda
CAIERAS, Brazil. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 210 registrations outside the US
- Establishments
- 1Brazil
Registered in 2 markets
Where regulators' registries name Andre Gregate Braga Instrumentos 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 | Andre Gregate Braga Instrumentos Ltda | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | ANDRE GREGATE BRAGA INSTRUMENTOS LTDAANDRE GREGATEBRAGA INSTRUMENTOS LTDA | 10 | 2024–2026 | 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 Andre Gregate Braga Instrumentos 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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Supremo IndustriaSupremo Surgical | 2023 |
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 |
|---|---|---|
| ANDRE GREGATE BRAGA INSTRUMENTOS LTDAFDA reg. 3030056132 | CAIEIRAS Sao Paulo, Brazil | Manufacturer, Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089341). 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.