FDA.reportPublic FDA data

Midmark PREVA IntraOral Dental X-ray System

Primary DI
00841709101847
Brand
Midmark PREVA IntraOral Dental X-ray System
Company
MIDMARK CORPORATION
Model
DCD6-W1B/S2
Catalog number
DCD6-W1B/S2
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
OTC
false
Sterile
false
Single use
false

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
00841709101847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709101847008417091018478417091018470841709101847

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
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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841709121920MidmarkLT-1400-096LT-1400-0962026-03-19
00841709122088MidmarkLT-1600-108LT-1600-1082026-03-19
00841709122217Midmark029-11924-02LT-15002026-03-19
00841709122132Midmark153839-013153839-0132026-03-11
00841709122149Midmark153720-011153720-0112026-03-11
00841709122156Midmark153740-012153740-0122026-03-11
00841709122163Midmark153740-013153740-0132026-03-11
00841709122170Midmark153740-014153740-0142026-03-11
00841709121913MidmarkLT-1300-001LT-1300-0012026-03-10
00841709121937MidmarkLT-1400-102LT-1400-1022026-03-10
00841709121944MidmarkLT-1400-108LT-1400-1082026-03-10
00841709121951MidmarkLT-1400-114LT-1400-1142026-03-10
00841709121968MidmarkLT-1400-120LT-1400-1202026-03-10
00841709121975MidmarkLT-1400-126LT-1400-1262026-03-10
00841709121982MidmarkLT-1400-132LT-1400-1322026-03-10
00841709121999MidmarkLT-1500-096LT-1500-0962026-03-10
00841709122002MidmarkLT-1500-102LT-1500-1022026-03-10
00841709122019MidmarkLT-1500-108LT-1500-1082026-03-10
00841709122026MidmarkLT-1500-114LT-1500-1142026-03-10
00841709122033MidmarkLT-1500-120LT-1500-1202026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800018424704XERO-alphaDRTECH CorporationEHD2026-03-17
08809244060649GenorayGENORAY CO., LTD.EHD2025-12-01
08809244060656GenorayGENORAY CO., LTD.EHD2025-12-01
08809244060663GenorayGENORAY CO., LTD.EHD2025-12-01
08809244060670GenorayGENORAY CO., LTD.EHD2025-12-01
00860014827303LifeRayLucas Lifecare, LLCEHD2025-10-21
03760262653006Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653013Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653020Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653044Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653051Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653068Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653075Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653327Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653334Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653372Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653389Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653396Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653402Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653419Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653426Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262652993Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-04
D804592151000x-mind dcDE GÖTZEN SRLEHD2025-09-04
D804592151010x-mind dcDE GÖTZEN SRLEHD2025-09-04
D804592151020x-mind dcDE GÖTZEN SRLEHD2025-09-04
D804592151070x-mind dcDE GÖTZEN SRLEHD2025-09-04
D804592151080x-mind dcDE GÖTZEN SRLEHD2025-09-04
D804592151090x-mind dcDE GÖTZEN SRLEHD2025-09-04
D804592151100x-mind dcDE GÖTZEN SRLEHD2025-09-04
D804592151110x-mind dcDE GÖTZEN SRLEHD2025-09-04