Duns Number:467001948
Device Description: CeraRoot Surgical Case (empty). It's used to store all the necessary instruments to perfor CeraRoot Surgical Case (empty). It's used to store all the necessary instruments to perform the dental CeraRoot implant surgery. It's made of polymer resistant to dental autoclaves.
Catalog Number
020.001
Brand Name
CeraRoot Implant System
Version/Model Number
020.001
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K093595
Product Code
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
f60e5749-8c80-4cc0-a1fb-d57d418ca41d
Public Version Date
September 23, 2019
Public Version Number
1
DI Record Publish Date
September 15, 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 |