Class Class U
Remi Custom Night Guard (K251778)
Description
Remi Custom Night Guard by Remi, an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK251778
Clearance Date2025-10-17
Clearance TypeTraditional
Product CodeOBR
FDA Database
View on FDA DatabasePredicate lineage for K251778
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. Remi Custom Night Guard (K251778) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K253641 | Owl Night Guard | Owl Dental Lab, Inc. | 2026 |
Trace the full predicate network for K251778
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.