Duns Number:036623932
Device Description: Glycol based solution to facilitate removal of carious dentin. Value pack includes (20) 1 Glycol based solution to facilitate removal of carious dentin. Value pack includes (20) 1.2ml prefilled syringes.
Catalog Number
-
Brand Name
Vista-Green Caries Indicator Value Pack
Version/Model Number
503500
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
K955445,K955445
Product Code
LFC
Product Code Name
Device, Caries Detection
Public Device Record Key
bc8a01d8-db45-45d7-870f-7cad61a1551f
Public Version Date
August 31, 2018
Public Version Number
1
DI Record Publish Date
July 31, 2018
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 | 316 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 144 |
| U | Unclassified | 36 |