Manufacturer registered with FDA
Alliage S/A Industrias Medico Odontologica
Ribeirao Preto, Brazil. Lists 8 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 8
- Brands and models
- 123
- 510(k) clearances
- 32021–2024
- Markets registered in
- 1098 registrations outside the US
- Establishments
- 1Brazil
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name Alliage S/A Industrias Medico Odontologica as the manufacturer or the registration holder of a device.
RegisteredHome: BrazilOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Alliage S/A Industrias Medico Odontologica | 3 clearances | 2021–2024 | Below |
| European Union | EUDAMED | Manufacturer | ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA | 25 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ALLIAGE S/A INDUSTRIAS MEDICO ODONTOLOGICAALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA | 25 | 2019–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ALLIAGE S/A INDUSTRIAS MEDICO ODONTOLOGICAALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA | 23 | 2004–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA | 10 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICAALLIAGE S/A INDUSTRIAS MEDICO ODONTOLOGICA · ALLIAGE S/A INDUSTRIAS MÉDICO ODONTOLÓGICA | 5 | — | Pure Global AI |
| Tanzania | TMDA | Manufacturer | ALLIAGE S/A INDUSTRIAS MEDICO ODONTOLOGICAAlliage S/A Industrias Medico Odontologica · alliage s/a industrias medico odontologica | 4 | 2023–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ALLIAGE S/ A INDUSTRIAS MEDICO ODONTOLOGICA | 3 | 2022–2022 | Pure Global AI |
| Australia | TGA | Manufacturer | Alliage S/A Industrias Medico Odontologica | 2 | 2023–2023 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Alliage S/A Industrias Medico Odontologica | 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 Alliage S/A Industrias Medico Odontologica currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | D700 SLIMEAGLE SEVOLVE SENSORPortable Dental X-RayPortable Dental X-Ray/AXR60 S/Eagle X-RayPortable Dental X-Ray/AXR60 S/Evolve PortablePortable Dental X-Ray/AXR65 S/Eagle X-RayPortable Dental X-Ray/AXR65 S/Evolve PortableSAEVO SLIM | 2023 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Artus Delivery UnitMini Delivery UnitNew Versa Water UnitSyncrus Alcance 3T BV UE Water UnitSyncrus Alcance 3T BV Water UnitSyncrus Alcance 3T V Water UnitSyncrus Alcance 3T Water UnitSyncrus Alcance 4T BV UE Water UnitSyncrus Alcance 4T BV Water UnitSyncrus Alcance 4T V Water Unit 35 moreSyncrus Alcance 4T Water UnitSyncrus Alcance 5T BV Water UnitSyncrus Alcance 5T V Water UnitSyncrus G1 Water UnitSyncrus G2 Delivery UnitSyncrus G2 Water UnitSyncrus G3 Delivery UnitSyncrus G3 H Delivery UnitSyncrus G3 Water UnitSyncrus G4 Water UnitSyncrus G4A Water UnitSyncrus G8 F Delivery UnitSyncrus G8 FE Delivery UnitSyncrus G8 H Delivery UnitSyncrus G8 HE Delivery UnitSyncrus G8 Water UnitSyncrus GLX Delivery UnitSyncrus H Delivery UnitSyncrus HLX Delivery UnitSyncrus LS Delivery UnitSyncrus Water Unit1402 2 HP All-in-one Delivery Unit1402 2 HP Delivery Unit1403 2HP Dual Mount Unit1407 3 HP Delivery Unit1407D 4 HP Delivery Unit1407H 2 HP All-in-one Hygiene Delivery Unit1408 3 HP dual Mount Unit1414 Wall Mount Unit1416 2HP Panel Mounted Unit1416 3HP Panel Mounted Unit1440 EURO 4 HP Delivery Unit1455 4 HP Delivery Unit1607 Cuspidor1655 Cuspidor | 2008 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | DENTAL CT SCANNER AXREagle Edge/Dabi Atlante AXR120Eagle Edge/Dabi Atlante AXR90Evolve/Prexion AXR120Evolve/Prexion AXR90Prexion AXR120 ElitePrexion Excelsior AXR120 BPrexion Excelsior AXR90 BSXR/Saevo AXR120 BSXR/Saevo AXR90 B | 2021 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | E-DU Dental LightPersus L Dental LightPersus LED Dental LightPersus Piso Dental LightSirius C1 Dental LightSirius C2 Dental LightSirius G8 1 LED Dental LightSirius G8 2 LEDs Dental LightSirius G8 3 LEDs Dental LightSirius G8 4 (2x2) LEDs Dental Light 14 moreSirius G8 4 LEDs Dental LightSirius G8 5 (3x2) LEDs Dental LightSirius G8 5 LEDs Dental LightSirius G8 SENSOR 1 LED Dental LightSirius G8 Sensor 2 LEDs Dental LightSirius G8 Sensor 3 LEDs Dental LightSirius G8 Sensor 4 (2x2) LEDs Dental LightSirius G8 Sensor 4 LEDs Dental LightSirius G8 Sensor 5 (3x2) LEDs Dental LightSirius G8 Sensor 5 LEDs Dental Light1335 Chair Mounted Light1340MD Ceilng Mounted Light1340MD Chair Mounted Light1340MD Wall Mounted Light | 2008 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | SYNCRUS G4 | 2026 |
| Dental Chair with Operative UnitKLC · Class 1 | Dental chairs & operative units | Maker | Croma Dental ChairD1 Dental ChairGalla Dental ChairNew Croma Dental ChairNew Croma T5 Dental ChairNew Galla Dental ChairNew Versa Dental ChairS500 Dental ChairSDS Biscayne Chair and PartsSDS Biscayne EL chair and parts 16 moreSDS Daytona Chair and PartsSDS Ortho Chair and PartsSDS Palm Beach Chair and partsSyncrus Dental ChairSyncrus G2 Dental ChairSyncrus G3 Dental ChairSyncrus G4 Dental ChairSyncrus G8 Dental ChairSyncrus GL Dental ChairSyncrus GLX Dental ChairT5 Dental Chair5000FB Biscayne Fixed Base Chair6000EL Biscayne E.L Chair7000BY Biscayne Chair8000DY Daytona Chair9000PB Palm Beach Chair | 2008 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | D700 SLIMEAGLE SEVOLVE SENSORSAEVO SLIM | 2023 |
| Intraoral CameraQJK · Class 2 | Intraoral cameras | Maker | AXR-S Eagle ScanAXR-S Evolve ScanEagle IOSEVOLVE IOS | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Alliage S/A Industrias Medico Odontologica as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Jan 2024 | K233395 | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) | EHD Extraoral with Timer X-Ray Unit |
| 7 Apr 2023 | K223816 | Dental CT Scanner AXR | OAS Dental Computed Tomography X-Ray |
| 10 Aug 2021 | K210820 | EAGLE EDGE AXR90 and AXR120 | OAS Dental Computed Tomography X-Ray |
Also lists devices cleared under other names
Alliage S/A Industrias Medico Odontologica lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Sds Dental, Inc. (4), Alliage S/A Industrias Medica Odontológico. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Apr 2023 | K230732 | Eagle S/Saevo Slim/D700 Slim | Alliage S/A Industrias Medica Odontológico. | MUH Digital Extraoral Source X-Ray System |
| 22 Jan 1997 | K964619 | DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) | Sds Dental, Inc. | EIA Operative Dental Unit |
| 1 Oct 1986 | K863021 | CM-II, CM-I WATER UNIT | Sds Dental, Inc. | EIA Operative Dental Unit |
| 1 Oct 1986 | K863016 | DENTATUS L SET | Sds Dental, Inc. | KLC Dental Chair with Operative Unit |
| 29 Sep 1986 | K863019 | F-11 REFLECTOR / F-II STANDARD REFLECTOR | Sds Dental, Inc. | EAZ Dental Operating Light |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Alliage S/A Industrias Medico OdontologicaFDA reg. 3002819275 | Ribeirao Preto Sao Paulo, Brazil | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10024158). 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.