Manufacturer registered with FDA
Indusbello Ind. e Com. de Prod. Med. e Odont. Ltda.
Londrina, Brazil. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Brazil
Devices listed with FDA
What Indusbello Ind. e Com. de Prod. Med. e Odont. 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | INDUSBELLO | 2021 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | INDUSBELLO | 2021 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | INDUSBELLO | 2021 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | INDUSBELLO | 2013 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | INDUSBELLO | 2021 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | INDUSBELLO | 2021 |
| Tube Impression and MatrixKCQ · Class 1 | — | Maker | INDUSBELLO | 2021 |
| Dental Stain EraserMAU · Class 1 | — | Maker | INDUSBELLO | 2021 |
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 |
|---|---|---|
| INDUSBELLO INDUSTRIA DE INSTRUMENTOS ODOFDA reg. 3009170227 | Londrina Parana, Brazil | Manufacturer |
Other names on FDA records
Indusbello Industria de Instrumentos Odo
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10036368). 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.