Duns Number:480420090
Device Description: Abrasive strips are used during restorative treatments to adjust / shape / smooth / reduce Abrasive strips are used during restorative treatments to adjust / shape / smooth / reduce the interproximal area & contact points of the tooth‘s crown (artificial or natural). The abrasive strips are made of stainless-steel base coated with abrasive grit (corundum or diamond). The products are used in the dentistry field.Pack of 12 pcs
Catalog Number
-
Brand Name
STEEL ABRASIVE STRIPS, 4 mm, double side coated, coarse grits
Version/Model Number
46123
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
EHM
Product Code Name
Strip, Polishing Agent
Public Device Record Key
21964998-5a69-4752-94d1-d93479f78a4e
Public Version Date
July 07, 2022
Public Version Number
1
DI Record Publish Date
June 29, 2022
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 | 278 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |