Duns Number:113170088
Device Description: Reliance Extend LTR is intended for use as a lingual retention wire.Kit contains Reliance Extend LTR is intended for use as a lingual retention wire.Kit contains Kit includes 5 x 18mm, 5 x 20mm, 5 x 22mm, 5 x 24mm and 5 x 26 mm Extend TMA Wires. Kit also includes 25 measuring devices.
Catalog Number
EXK
Brand Name
Extend
Version/Model Number
EXK
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
4c8963dc-8952-4ad3-beec-1e27acf78c38
Public Version Date
July 24, 2020
Public Version Number
4
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 |