FDA.reportPublic FDA data

EAGLE X-RAY

Primary DI
07899581337437
Brand
EAGLE X-RAY
Company
Alliage S/A Indústrias Médico Odontológica
Model
AXR60 S
Catalog number
16000003495
Published
2024-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EHDUnit, X-Ray, Extraoral With Timer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233395000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233395000Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)Alliage S/A Industrias Médico Odontológica2024-01-03EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899581337437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899581337437078995813374377899581337437

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-18 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
898231451
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899581345197Intraoral ScannerAXR-S160000047592026-08-22
07899581360671Intraoral ScannerAXR-S160000047922026-08-22
07899581361289Evolve PortableAXR60 S160000047972026-08-22
07899581339639Dental CT Scanner AXRAXR90160000040582023-10-18
07899581342707Delivery UnitSyncrus G2410000082932025-12-31
07899581342844Delivery UnitSyncrus G3410000083072025-12-31
07899581343186Delivery UnitSyncrus G3 H410000083092025-12-31
07899581343414Delivery UnitSyncrus G8 FE410000083492025-12-31
07899581343599Delivery UnitSyncrus G8 HE410000083502025-12-31
07899581343834Water UnitSyncrus G2410000081882025-12-31
07899581343933Water UnitSyncrus G2410000081842025-08-01
07899581343957Water UnitSyncrus G3410000081992025-08-01
07899581344015Water UnitSyncrus G4A410000082052025-08-01
07899581340925Dental ChairSyncrus G2410000081562025-07-25
07899581340703EAGLE X-RAYAXR65 S160000043752024-02-26
07899581340642Dental CT Scanner AXRAXR120160000042552024-02-23
07899581340659Dental CT Scanner AXRAXR120160000042562024-02-23
07899581340734SXR / SaevoAXR90 B160000043702024-02-23
07899581340741SXR / SaevoAXR120 B160000043712024-02-23
07899581340758SXR / SaevoAXR90 B160000043772024-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941877830557EighteethChangzhou Sifary Medical Technology Co., Ltd.EHD2026-10-08
08800000995809N1Osstem Implant Co.,Ltd.EHD2026-08-27
07899581361289Evolve PortableAlliage S/A Indústrias Médico OdontológicaEHD2026-08-22
08800021800168XTGDigiMed Co., Ltd.EHD2026-06-01
08800021800175XTG VDigiMed Co., Ltd.EHD2026-06-01
D090800047970NOMAD Pro 3 X-Ray Tubehead, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048750NOMAD Pro 3 Packaged System, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048870NOMAD Pro 3 Packaged System, US Dental Imaging Technologies CorporationEHD2026-03-31
08809840720046WeRayPICOPACK Inc.EHD2024-10-24
08800021800045BIOXDigiMed Co., Ltd.EHD2024-06-12
08800021800106HYBRID S70DigiMed Co., Ltd.EHD2024-06-12
08800021800120XTG PRO 70DigiMed Co., Ltd.EHD2024-06-12
08800021800137DHX-70HDigiMed Co., Ltd.EHD2024-06-12
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340284Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340697Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340727Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
08800021800113xm-liteDigiMed Co., Ltd.EHD2022-12-01
08800124900000CLAROXVSI Co., Ltd.EHD2022-07-25
08800072313211Portable Dental X-ray (CS 2400P)NANORAY CO.,LTDEHD2021-02-18
08800072313310Portable Dental X-ray (CS 2300P)NANORAY CO.,LTDEHD2021-02-18
08800072313419Portable Dental X-ray (NR-F350 with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313518Portable Dental X-ray (R2 Port-X without Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313617Portable Dental X-ray (R2 Port-X with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
00841709112577MidmarkMIDMARK CORPORATIONEHD2021-01-15
00841709112713MidmarkMIDMARK CORPORATIONEHD2021-01-15
00841709112850MidmarkMIDMARK CORPORATIONEHD2021-01-15