DEVICE: remanium® (J011767207000)
Device Identifier (DI) Information
remanium®
767-207-00
In Commercial Distribution
DENTAURUM GmbH & Co.KG
767-207-00
In Commercial Distribution
DENTAURUM GmbH & Co.KG
remanium® ideal arches, rectangular Mandibular, 0.55 x 0.70 mm / 21,5 x 28
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? |
---|---|---|---|---|
41397 | Orthodontic archwire |
A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZC | WIRE, ORTHODONTIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K935140 | 000 |
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
f76453ff-59aa-40b0-91fa-d7cf65134b97
July 06, 2018
3
September 15, 2016
July 06, 2018
3
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:
J011767207001
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)523-3946
info@dentaurum-us.com
info@dentaurum-us.com