FDA Update: 510 (k) Premarket Notification Approval
Premarket approval by the FDA is a regulatory approval process that allows the manufacturer to market and distribute the device within the US. The following premarket approvals were issued recently:
| Device |
Manufacturer |
Decision Date |
Indications for Use |
| Park Dental Nylon MAD |
Park Dental Research Corp. |
12/18/2025 |
Intended to reduce or alleviate snoring and mild to moderate OSA in adults. |
To search for the full list of devices that are FDA-cleared, visit the FDA’s 510 (k) Premarket Notification database and search using product code LQZ (Device, jaw repositioning) or LRK (Device, anti-snoring).
To see the indications for use of a cleared appliance:
- Click on the appliance’s name in the database’s search results
- Click on the linked summary for the device to see a summary of the indications for use, FDA’s approval letter, and the manufacturer’s application letter
