Duns Number:603741349
Device Description: Clear sequential aligner / progressive orthodontic appliance system.
Catalog Number
-
Brand Name
Tru-Smile
Version/Model Number
TSCA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K173785
Product Code
NXC
Product Code Name
Aligner, Sequential
Public Device Record Key
ba4da5e9-89d1-4c31-991a-167b9a11a967
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
April 15, 2020
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |