Duns Number:748034696
Device Description: The OVENT device is for the treatment of snoringand/or obstructive sleep apnea and is comp The OVENT device is for the treatment of snoringand/or obstructive sleep apnea and is comprised of:• A titanium bimaxillary oral appliance whichcomprises, in one device, a lower tray fitted over thelower teeth and an upper tray fitted over the upperteeth.• A dental polymer material in each tray which is incontact with and retaining in position, the user’s topand bottom teeth.• The lower jaw is retained in an advanced position tohelp open up the natural airway and alleviate theuser’s snoring condition.• A breathing port at the front of the appliance with anenclosed airway on each side which passes betweenthe teeth and the cheek. Each airway delivers the airat the rear of the mouth typically between the lastteeth. The airways allow the user to breathe with themouth closed.
Catalog Number
-
Brand Name
O2Vent Mono (OVENT)
Version/Model Number
O2Vent Mono
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160234
Product Code
LRK
Product Code Name
Device, Anti-Snoring
Public Device Record Key
1393c5db-a0e2-40d8-b08b-6ba705de6b17
Public Version Date
June 07, 2019
Public Version Number
1
DI Record Publish Date
May 30, 2019
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. | 5 |