Duns Number:096010525
Device Description: Improv - A Resin-Based Provisional Luting Agent Designed for Temporary Cementation of Impl Improv - A Resin-Based Provisional Luting Agent Designed for Temporary Cementation of Implants and Conventional Crown and Bridge Restorations.
Catalog Number
AV-4400
Brand Name
Improv Temporary Implant Cement by Dentegris Dental Implant System
Version/Model Number
AV-4400
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
For Single-Use
Yes
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
K982400
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
c83af62e-0b81-44ab-878d-051e79f6557c
Public Version Date
December 21, 2020
Public Version Number
1
DI Record Publish Date
December 11, 2020
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |