Class Class II
Rest Assure System (K233497)
Description
Rest Assure System by Somnomed, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233497
Clearance Date2024-10-03
Clearance TypeTraditional
Product CodePLC
Regulation Number872.5570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233497
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Rest Assure System (K233497) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183443 | SomnoDent Avant | Somnomed, Inc. | 2019 |
| K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent ... | Somnomed, Inc. | 2015 |
Trace the full predicate network for K233497
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.