FDA.reportPublic FDA data

A/T 2000 XR Intraoral Film Processor with Water Recirculation System

Primary DI
D678450040
Brand
A/T 2000 XR Intraoral Film Processor with Water Recirculation System
Company
AIR TECHNIQUES, INC.
Model
45004
Device description
A/T 2000 XR Intraoral Film Processor with Water Recirculation System provides high quality radiographs in any size such as Panoramic, Cephalometric, TMJ, Occlusal and all Intraorals. Includes: 1 levelling base, 1 bottle spray 2000 Plus; 4 Air Techniques cleaning films; 1 instructional DVD: 1 case chemistry, 1 bottle of starter, and 2 1/2 gallon water container.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IXWProcessor, Radiographic-Film, Automatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXWProcessor, Radiographic-Film, AutomaticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001321000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001321000ALL-PRO 2010All-Pro Imaging Corp.2000-05-16IXW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D678450041PackageHIBCC1In Commercial Distribution
D678450040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental automated x-ray film processorA mains electricity (AC-powered) automated dental x-ray film processor designed to be used in the dental practise for the rapid processing of films. This x-ray film processing system will automatically develop, fix, wash, and dry dental x-ray film. It is typically of floor or desktop design.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth26Inch
Height15Inch
Weight75Pound
Width14.25Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-247-8324xx@xx.xx

Regulatory Flags#

DUNS number
043835081
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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D678J1205E0ScanX Duo TouchJ1205EJ1200E2026-03-27
D678J1205R0ScanX Duo TouchJ1205RJ1200R2026-03-27
D678NES44000FlowStar E-standNES44002026-01-05
D678NES44001FlowStar E-standNES44002026-01-05
D678734701Plate Transfer Box734702025-09-05
D678AS50X0AirStarAS50X2025-04-25
D678AS50X1AirStarAS50X2025-04-25
D678AS70X0AirStarAS70X2025-04-25
D67821701005000VistaScan Ultra View21701005002023-04-21
D678J12050ScanX Duo TouchJ1205J12002023-04-21
D678732482K1ScanX Barrier Envelopes73248-2K2023-09-12
D6787324801ScanX Barrier Envelopes73248-02019-08-23
D678A63410"Provecta HD 16"" Center to Center Wall Mounting Plate"A63412023-07-11
D678A63890Provecta HD Single Post Mounting PlateA63892023-07-11
D678A63301Provecta HD 16" Center to Center Wall Mounting PlateA63412023-07-11
D678A63361Provecta HD Single Post Mounting PlateA63892023-07-11
D678AS1200AirStar Clinical Air CompressorAS1202023-06-14
D678AS120C0AirStar Clinical Air CompressorAS120C2023-06-14
D678AS600AirStar Clinical Air CompressorAS602023-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060209580777IntraX Film ProcessorMEDIVANCE INSTRUMENTS LIMITEDIXW2022-08-06
05060209580814ExtraXtender Film ProcessorMEDIVANCE INSTRUMENTS LIMITEDIXW2022-08-06
B580IWX0Mini MedAFP MANUFACTURING, INC.IXW2019-06-19
08809413810181Automatic Radiographic Film ProcessorJPI HEALTHCARE. CO., LTD.IXW2017-08-01
04260502640005COMPACT 2PROTEC GmbH & Co. KGIXW2016-10-28
04260502640012ECOMAXPROTEC GmbH & Co. KGIXW2016-10-28
04260502640029OPTIMAXPROTEC GmbH & Co. KGIXW2016-10-28
04260502640036OPTIMAX 2010PROTEC GmbH & Co. KGIXW2016-10-28
D678450000A/T 2000 XR Intraoral Film ProcessorAIR TECHNIQUES, INC.IXW2016-09-23
D678940000Peri-Pro III Intraoral Film ProcessorAIR TECHNIQUES, INC.IXW2016-09-23