| K-number | K242510 |
| Device name | Geistlich Bio-Flow® |
| Applicant | Geistlich Pharma AG |
| Product code | NPM |
| Device class | Class II |
| Decision date | Mar 7, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.3930 |
Geistlich Bio-Flow® is a flowable bone grafting material consisting of bovine bone mineral granules and porcine collagen in an 80:20 ratio, pre-filled in a mixing syringe. It is intended for bone regeneration in contained dental defects, including extraction socket filling, periodontal defect filling, and peri-implant defect filling up to 4 mm × 5 mm × 4 mm.
Geistlich Bio-Flow® uses smaller granule particles (125–180 μm) compared to the predicate's block form (250–1000 μm) and is provided as dry granules in a pre-filled syringe rather than as a block. Both devices use identical materials (bovine bone mineral and porcine collagen), are single-use, and undergo radiation sterilization. The subject device's indications are a subset of the predicate's broader indications, restricting use to contained defects of specific types and limited sizes.
ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017 (sterilization); ISO 11607-1:2019, ASTM F1980:2007, ASTM F1886/F1886M:2016, ASTM F88:2015, ASTM F1929:2015, ASTM F2096:2011 (packaging); ICH Q1A(R2) (stability); ISO 10993 series (biocompatibility including cytotoxicity, sensitization, irritation, systemic toxicity, implantation, genotoxicity, hemocompatibility); USP <151> / Ph. Eur. Section 2.6.8 (pyrogenicity); ASTM F756:2017 (hemocompatibility).
The devices are substantially equivalent because both are single-use, radiation-sterilized bone grafting materials composed of bovine bone and porcine collagen derived from the same manufacturing process. Although the subject device has smaller granule particles and a flowable syringe form versus the predicate's block form, and narrower indications limited to contained defects, animal performance studies demonstrate comparable bone regeneration parameters (Defect Fill Area, Bone Regeneration Height, Bone-to-Granule-Contact) between the two devices at 8 and 12 weeks. These design differences do not raise safety or effectiveness concerns and the restricted indications represent a clinical subset rather than a fundamental use change.
View the full FDA submission: accessdata.fda.gov