Duns Number:043835081
Device Description: The A/T 2000 XR Intraoral Film Processor provides high quality radiographs in any size suc The A/T 2000 XR Intraoral Film Processor 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.
Catalog Number
-
Brand Name
A/T 2000 XR Intraoral Film Processor
Version/Model Number
45000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K001321,K001321
Product Code
IXW
Product Code Name
Processor, Radiographic-Film, Automatic
Public Device Record Key
1bbdcc53-d70f-48aa-acb6-f4327d4effea
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
D678450001
Quantity per Package
1
Contains DI Package
D678450000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |