DEVICE: dentaform® (J011878004000)
Device Identifier (DI) Information
dentaform®
878-004-00
In Commercial Distribution
DENTAURUM GmbH & Co.KG
878-004-00
In Commercial Distribution
DENTAURUM GmbH & Co.KG
dentaform® Snap Band, Tooth 16, Size 4
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? |
---|---|---|---|---|
38734 | Orthodontic metal band |
A thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. 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 |
---|---|
ECM | BAND, PREFORMED, ORTHODONTIC |
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
3d578fdc-f90d-4f99-9b16-a1070bba41e6
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:
J011878004001
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)523-3946
info@dentaurum-us.com
info@dentaurum-us.com