DEVICE: tomas® (J011302028000)
Device Identifier (DI) Information
tomas®
302-028-00
Not in Commercial Distribution
DENTAURUM GmbH & Co.KG
302-028-00
Not 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? |
---|---|---|---|---|
33592 | Orthodontic teeth positioner, preformed |
A prefabricated dental device, typically made of plastic, that is an impression of a perfected bite used to prevent a patient's teeth from shifting position, or to move teeth to a final position, after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position. This is a reusable device.
|
Obsolete | false |
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
dfc8f99e-305d-4c40-8756-7ce263878fcc
March 29, 2018
2
September 15, 2016
March 29, 2018
2
September 15, 2016
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:
J011302028001
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)523-3946
info@dentaurum-us.com
info@dentaurum-us.com