Duns Number:368788568
Device Description: Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional and thr Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose Throat) regions.
Catalog Number
30003114
Brand Name
Planmeca ProMax
Version/Model Number
ProMax 3D Max
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
OAS
Product Code Name
X-Ray, Tomography, Computed, Dental
Public Device Record Key
aed3985c-9402-4c13-8897-f48c3883891f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 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 |