Duns Number:033755180
Device Description: Tetra Bright AlignersTetra Bright Aligners appears to whiten teeth while correcting dentit Tetra Bright AlignersTetra Bright Aligners appears to whiten teeth while correcting dentition.
Catalog Number
-
Brand Name
OrthoFX
Version/Model Number
TB Aligner
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 27, 2020
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
-
Product Code
DYT
Product Code Name
Maintainer, Space Preformed, Orthodontic
Public Device Record Key
46b474d6-c23c-43d5-97c4-cf94ee23fb2d
Public Version Date
August 05, 2021
Public Version Number
7
DI Record Publish Date
March 18, 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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |