Class Class II
Injectable Root Canal Bioceramic Sealer (nRoot SP) (K250710)
Description
Injectable Root Canal Bioceramic Sealer (nRoot SP) by Enpuno Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250710
Clearance Date2025-06-11
Clearance TypeTraditional
Product CodeKIF
Regulation Number872.3820
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250710
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. Injectable Root Canal Bioceramic Sealer (nRoot SP) (K250710) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240304 | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1... | Enpuno Biotechnology Co., Ltd. | 2024 |
Trace the full predicate network for K250710
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.