FDA.reportPublic FDA data

Genoray

Primary DI
08809244060281
Brand
Genoray
Company
GENORAY CO., LTD.
Model
PAPAYA 3D Premium Plus
Published
2025-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MUHSystem, X-Ray, Extraoral Source, Digital
OASX-Ray, Tomography, Computed, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2
OASX-Ray, Tomography, Computed, DentalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200469000PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd.2020-09-16OAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809244060281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809244060281088092440602818809244060281

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
631064672
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809244061103GenorayPAPAYA2016-12-28
08809244061110GenorayPAPAYA Plus2016-09-24
08809244061127GenorayPAPAYA 3D2016-12-28
08809244061134GenorayPAPAYA 3D Plus2016-09-24
08809244060533GenorayBELLIGER ACE2026-04-10
08809244060557GenorayAREX2026-04-10
08809244060632GenorayVETERA ACE2026-04-10
08809244060076GenorayGenX-CR2023-09-25
08809244060335GenorayGT3002025-12-01
08809244060472GenorayGT300-C2025-12-01
08809244060601GenorayVETERA FD2025-12-01
08809244060618GenorayVETERA PRIME2025-12-01
08809244060625GenorayVETERA CLASSIC2025-12-01
08809244060649GenorayVETERA DW2025-12-01
08809244060656GenorayVETERA DM2025-12-01
08809244060663GenorayVETERA PX2025-12-01
08809244060670GenorayVETERA PE2025-12-01
08809244060700GenorayVETERA TURBO2025-12-01
08809244065088GenorayHESTIA2025-07-24
08809244060090GenorayZEN-2090 Turbo2025-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975066322066MeyerHefei Meyer Optoelectronic Technology Inc.OAS2026-09-30
06975066322080MeyerHefei Meyer Optoelectronic Technology Inc.OAS2026-09-30
06975066322097MeyerHefei Meyer Optoelectronic Technology Inc.OAS2026-09-30
06975066322103MeyerHefei Meyer Optoelectronic Technology Inc.OAS2026-09-30
00850461008059APIXIA DIGIREXDENTAMERICA, INC.MUH2026-07-23
00850461008066APIXIA DIGIREXDENTAMERICA, INC.MUH2026-07-23
00854810007168CLARISIcRco, Inc.OAS2026-07-22
00860011175704A2Z ImagingZINNOVI INC.MUH2026-06-05
00860011175711A2Z ImagingZINNOVI INC.MUH2026-06-05
08800016401936Green X 12 SEVATECH CO., LTD.OAS2026-06-01
08800016401943Green X 12 SEVATECH CO., LTD.OAS2026-06-01
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
60192155951237CS 9600CARESTREAM DENTAL LLCOAS2026-05-15
60192155951244CS 9600CARESTREAM DENTAL LLCOAS2026-05-15
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