Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002819275

FEI Number

3002819275

Entity Name

Alliage S/A Industrias Medico Odontologica

City/State/Country

Ribeirao Preto Sao Paulo, BR

Establishment Address

Rodovia Abrao Assed Km 53+450 metros, Recreio Anhanguera, Ribeirao Preto Sao Paulo 14097-500, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Alliage S/A Industrias Medico Odontologica (Owner Number: 10024158)

Owner / Operator Contact Address

Rodovia Abrao Assed Km 53+450 metros, Recreio Anhanguera, Ribeirao Preto, BR-SP 14097-500, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K964619

PMA Number

N/A

All Registered Proprietary Names

Prexion Excelsior DENTAL CT SCANNER AXR SXR/SAEVO PREXION EVOLVE EAGLE EDGE/DABI ATLANTE 7000BY Biscayne Chair 6000EL Biscayne E.L Chair 5000FB Biscayne Fixed Base Chair SDS Ortho Chair and Parts 9000PB Palm Beach Chair SDS Palm Beach chair and parts SDS Biscayne EL chair and parts SDS Biscayne Chair and Parts 8000DY Daytona Chair SDS Daytona Chair and Parts 9000PB Palm Beach Chair 6000EL Biscayne E.L Chair Croma Dental Chair New Croma Dental Chair New Versa Dental Chair Syncrus GL Dental Chair 5000FB Biscayne Fixed Base Chair S500 Dental Chair T5 Dental Chair Syncrus G2 Dental Chair Syncrus GLX Dental Chair SDS Biscayne EL chair and parts 8000DY Daytona Chair New Croma T5 Dental Chair Galla Dental Chair SDS Ortho Chair and Parts Syncrus Dental Chair SDS Palm Beach Chair and parts SDS Daytona Chair and Parts 7000BY Biscayne Chair New Galla Dental Chair Syncrus G8 Dental Chair Syncrus G3 Dental Chair Syncrus G4 Dental Chair SDS Biscayne Chair and Parts D1 Dental Chair Portable Dental X-Ray/AXR65 S/Eagle X-Ray Portable Dental X-Ray/AXR65 S/Evolve Portable Portable Dental X-Ray Portable Dental X-Ray/AXR60 S/Eagle X-Ray Portable Dental X-Ray/AXR60 S/Evolve Portable 1340MD Chair Mounted Light Sirius G8 Sensor 5 LEDs Dental Light Sirius G8 5 (3x2) LEDs Dental Light Sirius G8 4 LEDs Dental Light Sirius C2 Dental Light Sirius G8 Sensor 4 LEDs Dental Light Persus Piso Dental Light 1340MD Ceilng Mounted Light 1335 Chair Mounted Light Sirius G8 Sensor 2 LEDs Dental Light Sirius G8 Sensor 4 (2x2) LEDs Dental Light Sirius G8 4 (2x2) LEDs Dental Light Sirius C1 Dental Light Sirius G8 2 LEDs Dental Light Sirius G8 3 LEDs Dental Light Sirius G8 5 LEDs Dental Light Persus LED Dental Light Sirius G8 Sensor 3 LEDs Dental Light 1340MD Wall Mounted Light Sirius G8 Sensor 5 (3x2) LEDs Dental Light Sirius G8 SENSOR 1 LED Dental Light Sirius G8 1 LED Dental Light Persus L Dental Light DENTAL CT SCANNER AXR 1403 2HP Dual Mount Unit Syncrus G8 HE Delivery Unit 1407D 4 HP Delivery Unit Syncrus G3 H Delivery Unit 1416 2HP Panel Mounted Unit Syncrus G3 Delivery Unit Syncrus LS Delivery Unit 1440 EURO 4 HP Delivery Unit Syncrus G8 H Delivery Unit 1455 4 HP Delivery Unit 1416 3HP Panel Mounted Unit 1402 2 HP All-in-one Delivery Unit Syncrus G8 F Delivery Unit 1408 3 HP dual Mount Unit 1402 2 HP Delivery Unit Artus Delivery Unit Syncrus G8 FE Delivery Unit 1414 Wall Mount Unit 1407H 2 HP All-in-one Hygiene Delivery Unit Syncrus G2 Delivery Unit Mini Delivery Unit Syncrus H Delivery Unit Syncrus HLX Delivery Unit 1407 3 HP Delivery Unit Syncrus GLX Delivery Unit Syncrus G2 Water Unit Syncrus G1 Water Unit Syncrus Alcance 3T Water Unit Syncrus Alcance 3T BV Water Unit Syncrus Water Unit New Versa Water Unit Syncrus G4A Water Unit Syncrus G3 Water Unit 1607 Cuspidor Syncrus G4 Water Unit Syncrus G8 Water Unit Syncrus Alcance 3T BV UE Water Unit 1655 Cuspidor Syncrus Alcance 4T BV Water Unit Syncrus Alcance 4T Water Unit Syncrus Alcance 4T V Water Unit Syncrus Alcance 5T BV Water Unit Syncrus Alcance 3T V Water Unit Syncrus Alcance 4T BV UE Water Unit Syncrus Alcance 5T V Water Unit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2023-05-12
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2013-06-21
KLC	Chair, Dental, With Operative Unit	Dental	Class 1	872.6250	2008-10-30
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2024-01-15
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2008-10-30
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2021-08-10
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2008-10-30
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2008-10-30

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Kamm Business: Kamm & Associates Email: fda.help.now@gmail.com Phone: (847) 3741727

Related Public Records

Same Entity

Alliage S/A Industrias Medico Odontologica

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002819275. Last updated year: 2026. Please use registration number 3002819275 when referencing this establishment in official correspondence.