Class Class U
LIJIA Night Guard (K241369)
Description
LIJIA Night Guard by Lijia, LLC, an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK241369
Clearance Date2024-08-22
Clearance TypeTraditional
Product CodeMQC
FDA Database
View on FDA DatabasePredicate lineage for K241369
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. LIJIA Night Guard (K241369) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221369 | FBCC Night Guard | Fbcc, Inc. | 2022 |
| K210011 | JS Dental Lab Mouth Guard | Ampower Dental Laboratories, LLC | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243516 | Remi Custom Night Guard | Grindguard, Inc. | 2025 |
Trace the full predicate network for K241369
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.