DEVICE: tomas® (J011302028010)
Device Identifier (DI) Information
tomas®
302-028-01
In Commercial Distribution
DENTAURUM GmbH & Co.KG
302-028-01
In Commercial Distribution
DENTAURUM GmbH & Co.KG
tomas® anchorage system: tomas®-transfer cap
Device Characteristics
Labeling does not contain MRI Safety Information | |
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 |
---|---|
NDP | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: No special storage conditions required |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c571141d-4e2e-42d8-9cfd-633b4db7149b
December 01, 2021
3
February 11, 2017
December 01, 2021
3
February 11, 2017
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:
J011302028011
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)523-3946
info@dentaurum-us.com
info@dentaurum-us.com