Duns Number:801157132
Device Description: VISTADENT® OC CONSULTANT (LATIN AM)
Catalog Number
27-311-70L
Brand Name
VISTADENT® OC
Version/Model Number
27-311-70L
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
Issuing Agency
In HIBCC
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"
Yes
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
-
Product Code
LLZ
Product Code Name
System, image processing, radiological
Public Device Record Key
3ab71814-0c6f-4c77-b629-f5e45c424ffc
Public Version Date
February 21, 2022
Public Version Number
4
DI Record Publish Date
September 24, 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 | 66 |
2 | A medical device with a moderate to high risk that requires special controls. | 103 |
U | Unclassified | 13 |