Manufacturer registered with FDA
Maquira Industria de Produtos Odontologicos
Maringá, Brazil. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 24
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6258 registrations outside the US
- Establishments
- 1Brazil
Registered in 6 markets
Where regulators' registries name Maquira Industria de Produtos Odontologicos 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 | Maquira Industria de Produtos Odontologicos | 12 device types | — | Below |
| Brazil | ANVISA | Registration holder | MAQUIRA INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S.A. | 129 | 2007–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MAQUIRA INDUSTRIA DE PRODUTOS ODONTOLOGICOS S.A.MAQUIRA INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S.A. · MAQUIRA INDUSTRIA DE PRODUTOS ODONTOLOGICOS LTDA · +2 | 66 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MAQUIRA INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S.A.MAQUIRA INDUSTRIA DE PRODUTOS ODONTOLOGICOS S.A. · MAQUIRA INDUSTRIA DE PRODUTOS ODONTOLOGICOS LTDA. | 40 | 2012–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | MAQUIRA INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S.A. | 17 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | MAQUIRA INDUSTRIA DE PRODUTOS ODONTOLOGICOS LTDAMAQUIRA INDUSTRIA DE PRODUTOS ODONTOLOGICOS S.A. | 6 | 2016–2018 | 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 Maquira Industria de Produtos Odontologicos currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | PriZma 3D Bio Try-In | 2026 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | ODONTOLOGICAL ASPIRATOR WITH BONE COLLECTORSURGICAL ASPIRATOR | 2017 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Orthodontic Wax | 2023 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | CONE POSITIONER AUTOCLAVABLECONE POSITIONER CHEMICAL STERILIZATIONCONE POSITIONER ENDO+ AUTOCLAVABLECONE POSITIONER ENDO+ CHEMICAL STERILIZATIONDIGITAL POSITIONER CONE | 2017 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | AIRON POLYESTER ABRASIVE STRIPSAIRON STEEL ABRASIVE STRIP | 2024 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | RUBBER DAM CLAMP | 2017 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | AIRON BICARBONATEDIAMOND UNIVERSAL | 2017 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | PriZma 3D Bio CrownPriZma 3D Bio Crown DiamondPriZma 3D Bio Crown Tough | 2024 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | Fill CanalProvisory Temporary CementSurgical Cement | 2023 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | PriZma 3D Bio SplintPriZma 3D Bio Splint Soft | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | PriZma 3D Bio Guide | 2024 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | PriZma 3D Bio Ortho IBT | 2024 |
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 |
|---|---|---|
| MAQUIRA INDUSTRIA DE PRODUTOS ODONTOLOGICOSFDA reg. 3010245461 | Maringa Parana, Brazil | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054997). 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.