FDA.reportPublic FDA data

Acteon

Primary DI
08052870660022
Brand
Acteon
Company
DENTAL XRAY COMPANY SRL
Model
X-MIND prime 3D
Published
2019-07-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OASX-Ray, Tomography, Computed, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OASX-Ray, Tomography, Computed, DentalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180601000Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)Villa Sistemi Medicali S.P.A.2018-11-02OAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052870660022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052870660022080528706600228052870660022

GMDN Terms#

Term, Definition table
TermDefinition
Stationary panoramic/tomographic dental x-ray system, digitalA diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures. It uses digital techniques for image capture, manipulation and display and may include various image processing and analysis capabilities. This system is designed with the capability to produce two or more special purpose dental x-ray examinations: linear scanning, panoramic, cephalometric, linear tomography, spiral tomography, scanograms.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
439922846
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052870660015ActeonX-MIND prime2019-07-01
08052870660213Dental X-Ray CompanyEndograph DC2019-07-01
08052870660312Dental X-Ray CompanyEndos AC2019-07-01
08052870660411Dental X-Ray CompanyEndos ACP2019-07-01
08052870660510Dental X-Ray CompanyExplor-X AC2019-07-01
08052870660619Dental X-Ray CompanyExplor-X ACP2019-07-01
08052870660718Owandy RadiologyElios2019-07-01
08052870660817ActeonSopix 32019-07-01
08052870660916ActeonSopix 3 HD2019-07-01
08052870661012ActeonX-MIND evo 3D2019-07-01
08052870661210ActeonX-MIND evo D2019-07-01
08052870661418ActeonX-MIND evo2019-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800016401936Green X 12 SEVATECH CO., LTD.OAS2026-06-01
08800016401943Green X 12 SEVATECH CO., LTD.OAS2026-06-01
60192155951237CS 9600CARESTREAM DENTAL LLCOAS2026-05-15
60192155951244CS 9600CARESTREAM DENTAL LLCOAS2026-05-15
E27668234830Primevision 3DSIRONA Dental Systems GmbHOAS2026-04-30
D804W1203005DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203005FLDRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203010DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203015DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203015FLDRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203020DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
08033837934981myrayCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837935001myrayCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936091NewTomCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936107NewTomCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936176CastelliniCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936411CastelliniCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
E27668234260Primevision 3DSIRONA Dental Systems GmbHOAS2026-02-13
00990010312418DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312562DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312579DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312586DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312593DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312609DURAYBeyes Dental Canada IncOAS2025-12-15
08800003027026RAYSCANRay Co., LtdOAS2025-12-01
08809244060335GenorayGENORAY CO., LTD.OAS2025-12-01
08809244060472GenorayGENORAY CO., LTD.OAS2025-12-01
06974566270167FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566270181FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566271133FUSSENFussen Technology Co., Ltd.OAS2025-11-24