Duns Number:124763728
Device Description: Ti Bases can be used for all ceramic restorations, crowns, either single unit bridges, mil Ti Bases can be used for all ceramic restorations, crowns, either single unit bridges, milled bars, or hybrids.Ti Bases are attached to an implant as a prosthetic titanium base for attachment to implant abutments in order to restore function and esthetics in the oral cavity.
Catalog Number
-
Brand Name
PUR® Ti Base RP
Version/Model Number
904793
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
-
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
4d053e68-9279-4490-9659-5a18493444e5
Public Version Date
July 15, 2020
Public Version Number
1
DI Record Publish Date
July 07, 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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1346 |