Duns Number:467001948
Device Description: Twist Drill 2.8mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Ceramic.
Catalog Number
002.003
Brand Name
CeraRoot Implant System
Version/Model Number
002.003
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
K093595
Product Code
DZI
Product Code Name
Drill, Bone, Powered
Public Device Record Key
11d60b19-d7f0-4f1f-83f3-e6307763ca5c
Public Version Date
January 09, 2020
Public Version Number
2
DI Record Publish Date
September 14, 2019
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |