FDA.reportPublic FDA data

Planmeca ProSensor

Primary DI
06430035420308
Brand
Planmeca ProSensor
Company
Planmeca Oy
Model
ProSensor HD
Catalog number
10037245
Device description
Planmeca ProSensor, digital intraoral X-ray imaging system, is an accessory to dental intraoral x-ray devices. It is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Published
2016-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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
K091197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091197000PLANMECA PROSENSORPlanmeca Oy2009-07-29EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430035420308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035420308064300354203086430035420308

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
368788568
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430035420292Planmeca ProMaxProMax 2D100306882016-08-10
06430035420988Planmeca VisoG5 (G3)30048120, 30035196, 30016794, 30054720, 30064043, 2024-01-10
06430035420322Planmeca ProOneProOne30010469, 30054727, 300547352016-08-10
06430035420360Planmeca IntraProX10029551, 30054728, 30054748, 30054749, 30054750, 2016-08-10
06430035420445Planmeca ProMaxProMax 2D30003108, 30054723, 30064278, 30054724, 30054736, 2016-09-19
06430035420452Planmeca ProMaxProMax 2D30003107, 30054725, 30064279, 30054726, 30054738, 2016-09-19
06430035420476Planmeca ProMaxProMax 3D30003109, 30054721, 30064042, 30054722, 30054744, 2016-09-19
06430035420995Planmeca VisoG730048121,30016793, 300642692024-01-10
06430035420483Planmeca ProMaxProMax 3D Plus30016946, 30054717, 30054719, 30064041, 30054740, 2016-09-19
06430035420490Planmeca ProMaxProMax 3D Mid30003112, 30054742, 300547432016-09-19
06430035420551Planmeca VisoG730004941,30064509, 300547322018-09-21
06430035420100Planmeca SovereignClassic10032746, 100327472017-05-05
06430035420346Planmeca ProMaxProMax 3D300169432016-08-10
06430035420353Planmeca ProMaxProMax 3D Max100200192016-08-10
06430035420469Planmeca ProMaxProMax 3D300169452016-09-19
06430035420506Planmeca ProMaxProMax 3D Max300031142016-09-19
06430035420513Planmeca ProMaxProMax 3D Max300031152016-09-19
06430035420599Planmeca Romexis6100415462023-06-14
06430035420964Planmeca Pro50 Chair-2022-12-19
06430035420162Planmeca ChairChair100260002017-05-08

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
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07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
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07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
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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
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