Duns Number:016649253
Device Description: Upper mouth guard, migraine/tension headache, Jaw repositioning device
Catalog Number
-
Brand Name
Vivos DNA
Version/Model Number
3014680794
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160477
Product Code
OCO
Product Code Name
Mouthguard, Migraine/Tension Headache
Public Device Record Key
3354d9f5-038d-45d7-867b-28ea18a78a8f
Public Version Date
June 14, 2022
Public Version Number
2
DI Record Publish Date
September 08, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| U | Unclassified | 2 |