Class Class U
Remi Custom Night Guard (K243516)
Description
Remi Custom Night Guard by Grindguard, Inc., an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK243516
Clearance Date2025-02-10
Clearance TypeTraditional
Product CodeMQC
FDA Database
View on FDA DatabasePredicate lineage for K243516
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 (K243516) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241369 | LIJIA Night Guard | Lijia, LLC | 2024 |
| K200125 | Thermoforming Sheet Materials | Erkodent Erich Kopp GmbH | 2020 |
Trace the full predicate network for K243516
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.