Class Class II
Endocem MTA Premixed Regular (K213757)
Description
Endocem MTA Premixed Regular by Maruchi, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213757
Clearance Date2023-02-14
Clearance TypeTraditional
Product CodeKIF
Regulation Number872.3820
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213757
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. Endocem MTA Premixed Regular (K213757) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K102867 | IROOT FS | Innovative Bioceramix, Inc. | 2010 |
| K082943 | IROOT BP, MODEL IRBP 4609 | Innovative Bioceramix, Inc. | 2009 |
Trace the full predicate network for K213757
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.