Duns Number:368788568
Device Description: Planmeca ProX is an X-ray source to produce intraoral X-ray images for the diagnosis of te Planmeca ProX is an X-ray source to produce intraoral X-ray images for the diagnosis of teeth and adjacent structures.
Catalog Number
10029551
Brand Name
Planmeca Intra
Version/Model Number
ProX
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
278a67bc-ce9c-496d-a656-d4bf10a39331
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 10, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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. | 20 |