DEVICE: TLX SRAs And TLX Gold Abutments (07630031755179)
Device Identifier (DI) Information
TLX SRAs And TLX Gold Abutments
Final Abutments
In Commercial Distribution
037.2300
Institut Straumann AG
Final Abutments
In Commercial Distribution
037.2300
Institut Straumann AG
WT Gold Abutment, crown, H 4mm, Ceramicor®/POM
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? |
---|---|---|---|---|
44879 | Dental implant suprastructure, permanent, preformed |
A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NHA | Abutment, implant, dental, endosseous |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K213063 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep away from sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: 4 Millimeter |
Device Record Status
41478c11-b205-42f3-abb2-8faf1189f603
May 18, 2022
1
May 10, 2022
May 18, 2022
1
May 10, 2022
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(800)448-8168
info.usa@straumann.com
info.usa@straumann.com