Duns Number:013827410
Device Description: Ti Base, Titanium, 0.4mm Collar, 5.05mm Profile, YellowEngaging, 6.8mm HeightCompatible wi Ti Base, Titanium, 0.4mm Collar, 5.05mm Profile, YellowEngaging, 6.8mm HeightCompatible with:3.3, 4.1 & 4.8mm (4.8mm Platform) RN Roxolid SLActive and Roxolid SLA Tissue Level ITI Straumann implants
Catalog Number
Y1010
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
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
beb8c9fc-33b7-488b-94d8-8543caaebab9
Public Version Date
July 16, 2020
Public Version Number
1
DI Record Publish Date
July 08, 2020
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 |