FDA.reportPublic FDA data

BELRAY II

Primary DI
04952195093809
Brand
BELRAY II
Company
TAKARA BELMONT CORP.
Model
097
Catalog number
AR-97WKCNJ8
Device description
"097 X-RAY WK with 31""Arm"
Published
2016-09-21
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
MUHSystem,x-ray,extraoral source,digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093240000BELRAY IITakara Belmont Corp.2010-03-22EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04952195093809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04952195093809049521950938094952195093809

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)223-1192gstern@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

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Primary DI, Brand, Company table
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00860011175704A2Z ImagingZINNOVI INC.MUH2026-06-05
00860011175711A2Z ImagingZINNOVI INC.MUH2026-06-05
08800021800168XTGDigiMed Co., Ltd.EHD2026-06-01
08800021800175XTG VDigiMed Co., Ltd.EHD2026-06-01
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D090800045780DEXIS IXS Size 2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
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