Duns Number:689605054
Device Description: Device Description: DENTRIα Series is a dental CT, panoramic X-ray system, which is inten Device Description: DENTRIα Series is a dental CT, panoramic X-ray system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures.
Catalog Number
-
Brand Name
DENTRIα Series
Version/Model Number
DENTRIα
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160140
Product Code
OAS
Product Code Name
X-Ray, Tomography, Computed, Dental
Public Device Record Key
6ae6eaf3-c0d9-4393-a010-742a37b0469a
Public Version Date
January 06, 2022
Public Version Number
4
DI Record Publish Date
December 25, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |