FDA.reportPublic FDA data

OP 3D Vision

Primary DI
D090083081000
Brand
OP 3D Vision
Company
Dental Imaging Technologies Corporation
Model
0.830.8100
Device description
V8
Published
2022-03-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K162085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162085000i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International2016-11-10OAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV083081000PreviousHIBCC0
D090083081000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cone beam computed tomography system, head/neckA stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-voltage generator, x-ray detector, processor, reconstruction software, and patient support device (e.g., seat, stabilizing bite block); the patient is typically scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear/nose/throat (ENT) applications.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
800111106
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00693856000340DEXIS Imprevo SLIM TIPDEXIS Imprevo59456602026-08-07
D090101399140DEXIS IXS Size 2 Accessory Layer1.013.99142026-08-03
D090101399150DEXIS IXS Size 2 Accessory Layer1.013.99152026-08-03
D090101399160DEXIS IXS Size 2 Accessory Layer1.013.99162026-08-03
D090101399170DEXIS IXS Size 1 Accessory Layer1.013.99172026-08-03
D090101399180DEXIS IXS Size 1 Accessory Layer1.013.99182026-08-03
D090101399190DEXIS IXS Size 1 Accessory Layer1.013.99192026-08-03
D090101461070DEXIS IXS Size 1 Accessory Layer1.014.61072026-08-03
D090101461090DEXIS IXS Size 2 Accessory Layer1.013.29162026-08-03
D090101461480DEXIS Titanium Accessory Layer1.014.61482026-08-03
D090101461490DEXIS Titanium Accessory Layer1.014.61492026-08-03
D090101461500DEXIS Titanium Accessory Layer1.014.61502026-08-03
D090101461510DEXIS Titanium Accessory Layer1.014.61512026-08-03
D090101461520DEXIS Titanium Accessory Layer1.014.61522026-08-03
D090101397120IXS S2 Kit, CT, US, FR-CA1.013.97122026-05-12
00693856000203Assembly-IS 3700 SIDE TIPIS 3700TA08502025-12-04
00693856000227Assembly-IS 3700 POSTERIOR TIPIS 3700TA08602025-12-04
D090101329460DEXIS IXS Size 1 Sensor - R1.013.29461.013.29462026-04-01
D090101329470DEXIS IXS Size 2 Sensor - R1.013.29471.013.29472026-04-01
D090800045720DEXIS Ti2 Sensor - R - S8.000.45728.000.45722026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854810007168CLARISIcRco, Inc.OAS2026-07-22
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