Duns Number:467001948
Device Description: Impactor for implant CeraRoot 14. A metal hand-held manual surgical instrument designed to Impactor for implant CeraRoot 14. A metal hand-held manual surgical instrument designed to position the CeraRoot 14 into the alveolar bone. Its mode of application is by transmission of an impact force to drive the implant into its final position in the bone. The proximal end is a handle designed to absorb the impact from a surgical hammer or mallet. The distal end is shaped curved to conform to the implant shape and is made of PEEK. This is a reusable device.
Catalog Number
005.214
Brand Name
CeraRoot Implant System
Version/Model Number
005.214
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
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
cb71cb77-6252-4dda-ba8c-588a80133b04
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 |