Duns Number:113170088
Device Description: The Renew® Finishing System is intended for use in the removal of composite paste after de The Renew® Finishing System is intended for use in the removal of composite paste after debonding and polishing of the surface of enamel, porcelain, metal or composite.The Renew Finishing System Points #383 will remove small residual amounts of adhesive from the tooth surface and will polish the enamel without damage. It's rubberized tapered shape facilitates removal of adhesive close to the gingiva. The #383 Point is the second step in the Renew Finishing System Points. This is the Straight Handpiece Finishing Point.
Catalog Number
GRSPHP
Brand Name
Renew
Version/Model Number
GRSPHP
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
911112c1-2ff0-495b-bdcc-23c9e15f0727
Public Version Date
July 14, 2020
Public Version Number
1
DI Record Publish Date
July 06, 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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |