FDA.reportPublic FDA data

PHOT-X IIs Model 505

Primary DI
04952195280384
Brand
PHOT-X IIs Model 505
Company
TAKARA BELMONT CORP.
Model
505
Catalog number
AR-55WKCNJ6LCD
Device description
"PHOT-X IIS 505 WK with 26""Arm LCD Subcontroller"
Published
2018-02-01
Public version status
Update
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
K141293000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141293000PHOT-X IIS MODEL 505Takara Belmont Corporation2014-09-03EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04952195280384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04952195280384049521952803844952195280384

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)223-1192gsterm@belmontequip.com
+810662135945e-nishizawa@belmont.jp

Regulatory Flags#

DUNS number
690540349
Device count
1
DM exempt
true
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
04952195347414PHOT-X II, MODEL 303AR-33WKCNJ3AR-33WKCNJ32026-05-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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