Manufacturer registered with FDA
Bio-Art Equipamentos Odontologicos Ltda
SAO CARLOS, SAO PAULO, Brazil. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 641 registrations outside the US
- Establishments
- 1Brazil
Registered in 6 markets
Where regulators' registries name Bio-Art Equipamentos Odontologicos 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 | Bio-Art Equipamentos Odontologicos Ltda | 6 device types | — | Below |
| Brazil | ANVISA | Registration holder | BIOART EQUIPAMENTOS ODONTOLÓGICOS LTDA | 24 | 2008–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BIO-ART EQUIPAMENTOS ODONTOLOGICOS LTDA. | 10 | 2016–2023 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BIOART EQUIPAMENTOS ODONTOLOGICOS LTDABIO-ART EQUIPAMENTOS ODONTOLOGICOS LTDA | 5 | 2010–2018 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BIO ART EQUIPAMENTOS ODONTOLÓGICOS LTDA. | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Bio-Art Equipamentos Odontologicos Ltda | 1 | — | 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 Bio-Art Equipamentos Odontologicos 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 |
|---|---|---|---|---|
| ParallelometerEGI · Class 1 | Dental hand instruments | Maker | Surveyor B2 Dental Surveyor / Parallelometer for dental prosthetic laboratory applications | 2026 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | Microblaster Standard | 2006 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | PlastPress (Positive Pressure Machine 110V)Plastvac P7 (Vacuum Forming Machine 110V) | 2007 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | Articulator 4000-SArticulator A7 PlusArticulator Hanau Ulti-Mate | 2003 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | Elite FacebowStandard Facebow | 2012 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Thermoforming Material (Hard Crystal, PP Plate, Soft Opaque, Bicolor, Black, Blue, Green, Pink or White) | 2020 |
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 |
|---|---|---|
| BIO-ART EQUIPAMENTOS ODONTOLOGICOS LTDA.FDA reg. 3004095674 | SAO CARLOS Sao Paulo, Brazil | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2427609). 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.