Duns Number:113170088
Device Description: Tried and True (TNT) (Heaters) Ovoid Heat Activated Copper Nickel Titanium Lower Archwires Tried and True (TNT) (Heaters) Ovoid Heat Activated Copper Nickel Titanium Lower Archwires Size 0.017 x 0.025 inches
Catalog Number
OHAL1725
Brand Name
TNT
Version/Model Number
OHAL1725
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
DZC
Product Code Name
Wire, Orthodontic
Public Device Record Key
4a3fc9fc-7437-4d63-8ea2-61a54c3a4900
Public Version Date
December 02, 2019
Public Version Number
1
DI Record Publish Date
November 24, 2019
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 |