Duns Number:529128636
Device Description: This device is indicated for use in the alignment of permanent teeth through orthodontic t This device is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.
Catalog Number
-
Brand Name
NA
Version/Model Number
V1.0
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
-
Product Code
NXC
Product Code Name
Aligner, Sequential
Public Device Record Key
2615c058-e2dd-4595-9be2-3a7189bfaa8b
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
February 13, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |