Injectable Root Canal Bioceramic Sealer (i-MTA SP) (K241977)
Description
Injectable Root Canal Bioceramic Sealer (i-MTA SP) by Longly Biotechnology (Wuhan) Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241977
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 (i-MTA SP) (K241977) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212983 | Injectable Root Canal Bioceramic Sealer | Beijing C-Root Dental Medical Devic... | 2021 |
| K080917 | IROOT SP | Innovative Bioceramix, Inc. | 2008 |
Trace the full predicate network for K241977
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.