Duns Number:113170088
Device Description: Extend TMA Wires are intended for use as lingual retainer wires for bonding to cuspids onl Extend TMA Wires are intended for use as lingual retainer wires for bonding to cuspids only. Wire is Beta Titanium. This is the 18mm wire.
Catalog Number
EX18
Brand Name
Extend
Version/Model Number
EX18
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ECN
Product Code Name
Clamp, Wire, Orthodontic
Public Device Record Key
f3f58457-ecc7-45ab-bf3f-13694e9aef9d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 04, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |