510(k) K210694

Silent Nite Sleep Appliance with the Glidewell Hinge by Prismatik Dentalcraft, Inc. — Product Code LRK

K210694 is an FDA 510(k) premarket notification submitted by Prismatik Dentalcraft, Inc. for the device "Silent Nite Sleep Appliance with the Glidewell Hinge". The FDA issued a decision of Substantially Equivalent on Jun 16, 2021. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Prismatik Dentalcraft, Inc. has 58 other 510(k) clearances on record.