Class Class II
DenMat Bulk Fill Composite (K242097)
Description
DenMat Bulk Fill Composite by Den-Mat Holdings, LLC, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242097
Clearance Date2024-10-15
Clearance TypeTraditional
Product CodeEBF
Regulation Number872.3690
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242097
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. DenMat Bulk Fill Composite (K242097) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222581 | Stela Automix System | Sdi Limited | 2022 |
| K151088 | DMRC Bulk Fill | Danville Materials, LLC | 2015 |
Trace the full predicate network for K242097
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.