Duns Number:036623932
Device Description: 12.5 pH aqueous solution for temporary filling and cleansing root canals. Standard kit in 12.5 pH aqueous solution for temporary filling and cleansing root canals. Standard kit includes (10) Visco-Tips™ & (4) 1.2mL prefilled high pressure syringes.
Catalog Number
-
Brand Name
Vista-Cal Standard Kit
Version/Model Number
502600
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
K963922,K963922
Product Code
KIF
Product Code Name
Resin, Root Canal Filling
Public Device Record Key
4047995e-8827-400a-abde-8dccf9ba6db1
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 |