Duns Number:368788568
Device Description: Planmeca ProMax, panoramic X-ray imaging system with cephalostat, is an extraoral source X Planmeca ProMax, panoramic X-ray imaging system with cephalostat, is an extraoral source X-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Catalog Number
10030688
Brand Name
Planmeca ProMax
Version/Model Number
ProMax 2D
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
K051464
Product Code
MUH
Product Code Name
System,X-Ray,Extraoral Source,Digital
Public Device Record Key
68c2af7b-edb6-414c-b718-b77c2c35f204
Public Version Date
December 17, 2020
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 |