Duns Number:368788568
Device Description: Planmeca ProSensor, digital intraoral X-ray imaging system, is an accessory to dental intr Planmeca ProSensor, digital intraoral X-ray imaging system, is an accessory to dental intraoral x-ray devices. It is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Catalog Number
10037245
Brand Name
Planmeca ProSensor
Version/Model Number
ProSensor HD
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
K091197
Product Code
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
42893d1f-f7af-43b2-96ee-6704aab0a330
Public Version Date
July 06, 2018
Public Version Number
3
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 |