Class Class II
Xenograft Bovine Bone Particulate (K240133)
Description
Xenograft Bovine Bone Particulate by Collagen Solutions, LLC, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240133
Clearance Date2024-08-16
Clearance TypeTraditional
Product CodeNPM
Regulation Number872.3930
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240133
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. Xenograft Bovine Bone Particulate (K240133) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K043034 | OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS | Collagen Matrix, Inc. | 2005 |
Trace the full predicate network for K240133
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.