Duns Number:368788568
Device Description: Planmeca ProMax 3D Plus, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Planmeca ProMax 3D Plus, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Computed Tomography (CBCT) to produce three-dimensional images of the human teeth, jaws and skull.
Catalog Number
30016944
Brand Name
Planmeca ProMax
Version/Model Number
ProMax 3D Plus
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
K103689
Product Code
MUH
Product Code Name
System,X-Ray,Extraoral Source,Digital
Public Device Record Key
6531ad19-d3a3-4cd7-a726-b14d2ccfcf3b
Public Version Date
April 21, 2021
Public Version Number
4
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 |