Class Class II
ReminGel (K241489)
Description
ReminGel by Inter-Med, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241489
Clearance Date2025-01-08
Clearance TypeTraditional
Product CodeLBH
Regulation Number872.3260
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241489
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. ReminGel (K241489) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K120176 | SENZZZZZ AWAY | Centrix, Inc. | 2012 |
| K120109 | SUPER SEAL TOOTH DESENSITIZER | Phoenix Dental, Inc. | 2012 |
Trace the full predicate network for K241489
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.