Duns Number:113170088
Device Description: The Renew® Finishing System is intended for use in the removal of composite paste after de
Catalog Number
*RSP
Brand Name
Renew Finishing System
Version/Model Number
*RSP
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
-
Product Code
EJL
Product Code Name
Bur, Dental
Public Device Record Key
af0fab77-9b07-4857-812e-54d46b6a5d95
Public Version Date
March 23, 2020
Public Version Number
3
DI Record Publish Date
April 30, 2018
Package DI Number
D798RSPFG3
Quantity per Package
3
Contains DI Package
D798RSPFG0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |