FDA.reportPublic FDA data

Midmark PREVA IntraOral Dental X-ray System

Primary DI
00841709101687
Brand
Midmark PREVA IntraOral Dental X-ray System
Company
MIDMARK CORPORATION
Model
DCD6DE-W1X/H/S1
Catalog number
DCD6DE-W1X/H/S1
Device description
Intraoral X-ray
Published
2016-09-22
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841709101687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709101687008417091016878417091016870841709101687

GMDN Terms#

Term, Definition table
TermDefinition
Stationary intraoral dental x-ray system, digitalA diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-35 Degrees Celsius66 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-643-6275imagingtechsupport@midmark.com

Regulatory Flags#

DUNS number
005036025
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841709105791MidmarkIQvitals Zone, w/Nellcor SPO21-200-03202021-05-17
00841709105784MidmarkIQvitals Zone1-200-03102017-04-07
00841709105807MidmarkIQvitals Zone w/Masimo SPO21-200-03302017-04-07
00841709105814MidmarkIQvitals Zone, w/Wireless1-200-03402017-04-07
00841709105821MidmarkIQvitals Zone, w/Nellcor SPO2 and Wirless1-200-03502017-04-07
00841709105838MidmarkIQvitals Zone, w/Masimo SPO2 and Wireless1-200-03602017-04-07
00841709105869MidmarkIQvitals Zone, Non-Wireless4-000-06202017-04-07
00841709105876MidmarkIQvitals Zone, Non-Wireless with Nellcor SPO24-000-06222017-04-07
00841709105883MidmarkIQvitals Zone, Non-Wireless with Masimo SPO24-000-06242017-04-07
00841709105890MidmarkIQvitals Zone, Wireless without SPO24-000-07202017-04-07
00841709105906MidmarkIQvitals Zone, Wireless with Nellcor SPO24-000-07222017-04-07
00841709105913MidmarkIQvitals Zone, Wireless with Masimo SPO24-000-07242017-04-07
00841709107948MidmarkG3G32019-02-08
00841709107979MidmarkG5G52019-02-08
00841709107993MidmarkG6G62019-02-08
00841709108006MidmarkG7G72019-02-08
00841709108020MidmarkG14G142019-02-08
00841709108037MidmarkG10G102019-02-08
00841709108099MidmarkP21/CV3P21/CV32019-02-08
00841709108112MidmarkP21P212019-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
08800021800120XTG PRO 70DigiMed Co., Ltd.EHD2024-06-12
08800021800137DHX-70HDigiMed Co., Ltd.EHD2024-06-12
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
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
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
D7641000064510Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10
D7641000064561Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10
D7641000064571Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10