Duns Number:467001948
Device Description: Implant CeraRoot 12:10/4.1 Size L= 10mm Indicated for UPPER LATERAL INCISORS AND LO Implant CeraRoot 12:10/4.1 Size L= 10mm Indicated for UPPER LATERAL INCISORS AND LOWER INCISORSOne-piece zirconia dental Implant including abutment.
Catalog Number
120.010
Brand Name
CeraRoot Implant System
Version/Model Number
120.010
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
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
K093595
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
5d05d6a6-b13d-43f0-a3fa-6bf65dcffdce
Public Version Date
July 01, 2019
Public Version Number
4
DI Record Publish Date
February 08, 2018
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 |