FDA Product Code MQC: Mouthguard, Prescription
Leading manufacturers include Prismatik Dentalcraft, Inc..
2
Total
2
Cleared
58d
Avg days
2022
Since
List of Mouthguard, Prescription devices cleared through 510(k)
2 devices
Cleared
Feb 17, 2023
Glidewell TuffSplint™ Appliance Resin
Prismatik Dentalcraft, Inc.
Dental
60d
Cleared
Feb 23, 2022
Glidewell Appliance Resin, Hard/Soft
Prismatik Dentalcraft, Inc.
Dental
56d
How to use this database
This page lists all FDA 510(k) submissions for Mouthguard, Prescription devices (product code MQC). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Dental FDA review panel. Browse all Dental devices →