Duns Number:013827410
Device Description: Compatible with: 4.8mm Wide Neck (WN) ITI Straumann implantsTemporary Abutment, TitaniumNo Compatible with: 4.8mm Wide Neck (WN) ITI Straumann implantsTemporary Abutment, TitaniumNon-Engaging, 0.75mm Collar, 7mm Profile
Catalog Number
Z801
Brand Name
Diamodent
Version/Model Number
N/A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
a2114f03-b08a-4620-ba70-7eed153ace32
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
January 04, 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 | 78 |
2 | A medical device with a moderate to high risk that requires special controls. | 283 |