Duns Number:113170088
Device Description: INDICATIONS FOR USE: The Renew® Finishing System is intended for use in the removal of com INDICATIONS FOR USE: 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.Renew Diamond Burs #129 A medium abrasion diamond bur recommended for roughening and preparing plastic, composite restorations and metal surfaces.
Catalog Number
DB
Brand Name
Renew System
Version/Model Number
DB
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
-
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
5047c581-fdf4-485b-b2ac-8862f54cc5fe
Public Version Date
March 23, 2020
Public Version Number
3
DI Record Publish Date
July 25, 2016
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 |