Class Class II
Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® (K251786)
Description
Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® by Geistlich Pharma AG, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251786
Clearance Date2025-07-11
Clearance TypeSpecial
Product CodeNPM
Regulation Number872.3930
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251786
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. Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® (K251786) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242510 | Geistlich Bio-Flow® | Geistlich Pharma AG | 2025 |
| K240661 | Geistlich Bio-Oss® | Geistlich Pharma AG | 2024 |
| K122894 | GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH CO... | Geistlich Pharma AG | 2013 |
| K120601 | GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTL... | Geistlich Pharma AG | 2012 |
Trace the full predicate network for K251786
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.