Class Class II
One-Fil Putty Injectable (K251884)
Description
One-Fil Putty Injectable by Mediclus Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251884
Clearance Date2025-08-22
Clearance TypeSpecial
Product CodeKIF
Regulation Number872.3820
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251884
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. One-Fil Putty Injectable (K251884) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243353 | One-Fil Putty | Mediclus Co., Ltd. | 2025 |
Trace the full predicate network for K251884
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.