DEVICE: Inspire ICE (00889989002102)
Device Identifier (DI) Information
Inspire ICE
444-0711
In Commercial Distribution
ORMCO CORPORATION
444-0711
In Commercial Distribution
ORMCO CORPORATION
Clear Braces - Quad - L5L 22 ROTH -22/-1/4
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? |
---|---|---|---|---|
58937 | Orthodontic bracket, ceramic |
A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. 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 |
---|---|
EJF | BRACKET, METAL, 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 |
---|
Device Size Text, specify: Slot Width: .022 Inch |
Device Record Status
80a325eb-aec5-4d7f-aff1-9aed2092114a
March 29, 2018
2
September 08, 2016
March 29, 2018
2
September 08, 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:
10889989002109
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+18008541741
ormcocustcare@ormco.com
ormcocustcare@ormco.com