DEVICE: MEDENTiKA (EMKAK1100ET9)
Device Identifier (DI) Information
MEDENTiKA
K 1100-ET
In Commercial Distribution
K 1100-ET
MEDENTiKA GmbH
K 1100-ET
In Commercial Distribution
K 1100-ET
MEDENTiKA GmbH
Titanium base incl. Abutment screw
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 [?] |
---|---|
K170838 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: compatible with Nobel Biocare Brånemark NP 3.5 |
Device Record Status
49411891-cf0f-4e59-bca5-bb7845d408e2
November 14, 2022
3
May 31, 2019
November 14, 2022
3
May 31, 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 |
---|---|
GS1 | 04251574836526 |
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