Duns Number:078352849
Device Description: Set of 12 burs and 4 socket guides used to prepare osteotomies for dental implant placemen Set of 12 burs and 4 socket guides used to prepare osteotomies for dental implant placement in the mandible and maxilla.
Catalog Number
Osseodensification Bur Kit
Brand Name
DDP Osseodensification Bur Kit
Version/Model Number
Osseodensification Bur Kit
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
8bcccb03-f99d-4e39-aad0-8d4ef842282c
Public Version Date
May 17, 2022
Public Version Number
1
DI Record Publish Date
May 09, 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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |