FDA.reportPublic FDA data

U-SENSE HD

Primary DI
D804W13000050
Brand
U-SENSE HD
Company
DE GÖTZEN SRL
Model
U-SENSE HD SIZE 1.5
Catalog number
W1300005
Device description
Intraoral Sensor U-SENSE HD size 1.5
Published
2025-05-15
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
MUHSystem,X-Ray,Extraoral Source,Digital

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D804W13000050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental digital imaging sensor, intraoralAn analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390331376760imaging.italysupport@acteongroup.com

Regulatory Flags#

DUNS number
433051802
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D804W1203005DRT0X-MIND optima 3DXMO 3D WALL 100-240V 1210 + WS + MONITORW1203005.DRT2026-03-23
D804W1203005FLDRT0X-MIND optima 3DXMO 3D FLOOR 100-240V 1210 + WS + MONITORW1203005.FLDRT2026-03-23
D804W1203010DRT0X-MIND optima 3DXMO 3D CEPH 100-240V 1210 + WS + MONITORW1203010.DRT2026-03-23
D804W1203015DRT0X-MIND optima 3DXMO 3D WALL 100-240V 1210 NO WS NO MONITORW1203015.DRT2026-03-23
D804W1203015FLDRT0X-MIND optima 3DXMO 3D FLOOR 100-240V 1210 NO WS NO MONITORW1203015.FLDRT2026-03-23
D804W1203020DRT0X-MIND optima 3DXMO 3D CEPH 100-240V 1210 NO WS NO MONITORW1203020.DRT2026-03-23
D804592151000x-mind dcDC X-MIND 115V,SHORT CONE,BOTT 40 (16” - 40,64cm)5.92.151002025-09-04
D804592151010x-mind dcDC X-MIND 115V,SHORT CONE,BOTT 80 (16” - 40,64cm)5.92.151012025-09-04
D804592151020x-mind dcDC X-MIND 115V,SHORT CONE,BOTT 110 (16” - 40,64cm)5.92.151022025-09-04
D804592151070x-mind dcDC X-MIND 115V,SHORT CONE,TOP 40 (16” - 40,64cm)5.92.151072025-09-04
D804592151080x-mind dcDC X-MIND 115V,SHORT CONE,TOP 80 (16” - 40,64cm)5.92.151082025-09-04
D804592151090x-mind dcDC X-MIND 115V,SHORT CONE,TOP 110 (16” - 40,64cm)5.92.151092025-09-04
D804592151100x-mind dcDC X-MIND 115V VET,SHORT CONE,BOTT 40 (16” - 40,645.92.151102025-09-04
D804592151110x-mind dcDC X-MIND 115V VET,SHORT CONE,BOTT 80 (16” - 40,645.92.151112025-09-04
D804592151120x-mind dcDC X-MIND 115V VET,SHORT CONE,BOTT 110 (16” - 40,65.92.151122025-09-04
D804592151170x-mind dcDC X-MIND 115V VET,SHORT CONE,TOP 40 (16” - 40,64c5.92.151172025-09-04
D804592151180x-mind dcDC X-MIND 115V VET,SHORT CONE,TOP 80 (16” - 40,64c5.92.151182025-09-04
D804592151190x-mind dcDC X-MIND 115V VET,SHORT CONE,TOP 110 (16” - 40,645.92.151192025-09-04
D804W13000010U-SENSEU-SENSE SIZE 1W13000012020-02-27
D804W13000020U-SENSEU-SENSE SIZE 2W13000022020-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011175704A2Z ImagingZINNOVI INC.MUH2026-06-05
00860011175711A2Z ImagingZINNOVI INC.MUH2026-06-05
00860009306110Cleartooth Digital X-RayCLEARTOOTH ELECTRONICS, INC.MUH2026-05-27
08800011200060Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
08800011200084Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
D090101397120IXS S2 Kit, CT, US, FR-CADental Imaging Technologies CorporationMUH2026-05-12
D090101329460DEXIS IXS Size 1 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090101329470DEXIS IXS Size 2 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090800045720DEXIS Ti2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045730DEXIS IXS Size 1 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045740DEXIS IXS Size 1 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045750DEXIS IXS Size 2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045760DEXIS IXS Size 2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045770DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045780DEXIS IXS Size 2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800045790DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045810DEXIS IXS S2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045830DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045840DEXIS Ti2 Kit - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045850IXS S1 Warranty Replacement - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045860IXS S1 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045870IXS S2 Warranty NEW KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045880IXS S2 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049760DEXIS Ti2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049770DEXIS IXS Size 1 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049790DEXIS Ti2 Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049800DEXIS Ti2 Sensor & Acc. Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049810DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049820DEXIS IXS Size 2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800457100DEXIS Ti2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01