Duns Number:962613332
Device Description: 3D imaging application specialized in dental and medical applications such as implantology 3D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and restorative.
Catalog Number
-
Brand Name
InvivoDental ROW
Version/Model Number
6.0
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123519
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
ca96dad6-78c4-4919-9935-d341e4c3281d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 29, 2017
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. | 7 |