FDA.reportPublic FDA data

XZeal Z70 Wall

Primary DI
00868923000213
Brand
XZeal Z70 Wall
Company
XZEAL TECHNOLOGIES, INC.
Model
Medium Arm
Catalog number
XZ012
Device description
The XZeal Z70 Wall is an X-Ray source to produce intraoral images for the diagnosis of teeath and adjacent structures.
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K122582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122582000DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C)Denterprise International, Inc.2012-12-07EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868923000213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868923000213008689230002138689230002130868923000213

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
407 483-8859info@xzeal.us

Regulatory Flags#

DUNS number
041863955
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868923000206XZeal Z70 WallSmall ArmXZ0112016-09-27
00868923000220XZeal Z70 WallLarge ArmXZ0132016-09-27
00868923000237XZeal Z70 MobileOn wheelsXZ0212016-09-27
00868923000244XZeal Z70 Mobile VETOn wheelsXZ0222016-09-27
00868923000251XZeal Z70 Wall VETSmall ArmXZ0142016-09-27
00868923000268XZeal Z70 Wall VETMedium ArmXZ0152016-09-27
00868923000275XZeal Z70 Wall VETLarge ArmXZ0162016-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08800021800168XTGDigiMed Co., Ltd.EHD2026-06-01
08800021800175XTG VDigiMed Co., Ltd.EHD2026-06-01
D090800047970NOMAD Pro 3 X-Ray Tubehead, USDental Imaging Technologies CorporationEHD2026-03-31
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
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340284Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
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
00841709112577MidmarkMIDMARK CORPORATIONEHD2021-01-15
00841709112713MidmarkMIDMARK CORPORATIONEHD2021-01-15
00841709112850MidmarkMIDMARK CORPORATIONEHD2021-01-15