DEVICE: Vita CAD-Temp For Inlab (07630031744449)
Device Identifier (DI) Information
Vita CAD-Temp For Inlab
Crowns
In Commercial Distribution
010.4051
Institut Straumann AG
Crowns
In Commercial Distribution
010.4051
Institut Straumann AG
CARES® single unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
38595 | Custom-made dental crown, polymer |
A device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBG | CROWN AND BRIDGE, TEMPORARY, RESIN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K070991 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep away from sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
5dd06956-6362-46af-994c-5f65bb2402b4
October 25, 2023
3
July 23, 2019
October 25, 2023
3
July 23, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(801)448-8168
info.usa@straumann.com
info.usa@straumann.com