Duns Number:342602800
Catalog Number
-
Brand Name
Ritter Dental Implant System
Version/Model Number
TFI-5-16
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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
K131557
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
0e268199-f0cf-40e4-a53f-17710d76c4f2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 30, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 610 |