DEVICE: Rollo Bands (00190746041204)
Device Identifier (DI) Information
Rollo Bands
153299N-0R-1200
In Commercial Distribution
153299N-0R-1200
AMERICAN ORTHODONTICS CORPORATION
153299N-0R-1200
In Commercial Distribution
153299N-0R-1200
AMERICAN ORTHODONTICS CORPORATION
BAND ROLLO LR 1ST MOLAR SZ 12 W/9MM CANTILEVER FLAT NUT
Device Characteristics
MR Unsafe | |
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 |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
61c3f913-ea9c-44c0-b006-6ff9b8e5c645
January 20, 2025
4
January 22, 2020
January 20, 2025
4
January 22, 2020
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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)558-7687
info@americanortho.com
info@americanortho.com