Duns Number:603741349
Device Description: Clear sequential aligner (final retainer) / progressive orthodontic appliance system.
Catalog Number
-
Brand Name
Tru-Smile
Version/Model Number
TSR
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
DYT
Product Code Name
Maintainer, Space Preformed, Orthodontic
Public Device Record Key
2b943660-1c73-45fa-8c6f-05e580e8ce08
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 |