Duns Number:789664455
Device Description: Dental burs are a vital tool required for almost every dental treatment and procedure. The Dental burs are a vital tool required for almost every dental treatment and procedure. They are necessary for cutting, grinding, and removing hard and soft tissue and are designed to attach to the rotary dental handpiece for fast and efficient dental work.
Catalog Number
2022
Brand Name
Dental Diamond Burs
Version/Model Number
1
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
DZP
Product Code Name
Instrument, Diamond, Dental
Public Device Record Key
d55531e8-fe17-49c0-b1cf-f40bcb3691fb
Public Version Date
March 15, 2022
Public Version Number
1
DI Record Publish Date
March 07, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 59 |