FDA.reportPublic FDA data

PHOT-X II, MODEL 303

Primary DI
04952195347414
Brand
PHOT-X II, MODEL 303
Company
TAKARA BELMONT CORP.
Model
AR-33WKCNJ3
Catalog number
AR-33WKCNJ3
Device description
"PHOT-X II, MODEL 303 WK with 12""Arm"
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K042260000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042260000PHOT-X II, MODEL 303Takara Belmont USA, Inc.2004-09-07EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04952195347414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04952195347414049521953474144952195347414

GMDN Terms#

Term, Definition table
TermDefinition
Stationary intraoral dental x-ray system, analogueA diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The image is from film or phosphor plate.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)223-1192gstern@belmontequip.com

Regulatory Flags#

DUNS number
690540349
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04952195235728PHOT-X II, MODEL 303AR-33WKCNJ1AR-33WKCNJ12026-05-11
04952195347421PHOT-X II, MODEL 303AR-33WKCNJ5AR-33WKCNJ52026-05-11
04952195347438PHOT-X II, MODEL 303AR-33WKCNJ8AR-33WKCNJ82026-05-11
04952195483259Evogue Dental UnitAU-HV3610AU-HV36102026-05-11
04952195462339Evogue Dental UnitAU-HV3420C-USAU-HV3420C-US2025-03-26
04952195372331Bel-Nova LEDBel-Nova LEDAL-D107G-NA-H2020-11-20
04952195436170DG-770-RSTAW-G091X2023-11-08
04952195354627DG-770-FAW-G090X2021-06-11
04952195406692Bel-Halo Dental LightAL-D241G-NAAL-D241G-NA2023-06-16
04952195406708Bel-Halo Dental LightAL-D241W-NAAL-D241W-NA2023-06-16
04952195406715Bel-Halo Dental LightAL-D242G-NAAL-D242G-NA2023-06-16
04952195406722Bel-Halo Dental LightAL-D245G-NA-HAL-D245G-NA-H2023-06-16
04952195406739Bel-Halo Dental LightAL-D246G-EVAL-D246G-EV2023-06-16
04952195406746Bel-Halo Dental LightAL-D246G-QUAL-D246G-QU2023-06-16
04952195406753Bel-Halo Dental LightAL-D247G-NAAL-D247G-NA2023-06-16
04952195406760Bel-Halo Dental LightAL-D248G-NA-HAL-D248G-NA-H2023-06-16
04952195406777Bel-Halo Dental LightAL-D249W-XAL-D249W-X2023-06-16
04952195406784Bel-Halo Dental LightAL-D249W-XNAL-D249W-XN2023-06-16
04952195408504Evogue Dental UnitAU-HV3401WAU-HV3401W2023-06-16
04952195414505Belmont X-Calibur UnitAU-XV2570DVRAU-XV2570DVR2023-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
D7641000083061XIOS AESIRONA DENTAL, INC.EHD2019-06-06
D7641000081680XIOS AESIRONA DENTAL, INC.EHD2019-06-05
D7641000081790XIOS AESIRONA DENTAL, INC.EHD2019-06-05
D7641000083480XIOS AESIRONA DENTAL, INC.EHD2019-06-05
08800040900047POSKOM Co., Ltd.Poskom Co., Ltd.EHD2018-06-19
D7641000064510Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10
D7641000064561Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10
D7641000064571Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10