| K-number | K242817 |
| Device name | Jason membrane |
| Applicant | Botiss Biomaterials GmbH |
| Product code | NPL |
| Device class | Class II |
| Decision date | Dec 12, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.3930 |
Jason® membrane is a completely resorbable collagen barrier membrane made from porcine pericardium, used in dental and maxillofacial surgery to support guided tissue and bone regeneration. It is indicated for bone defects, sinus augmentation, ridge reconstruction, periodontal defects, and implant site augmentation, among other uses.
The subject device is identical to the predicate in material (porcine pericardium collagen), form (membrane), sizes (15×20, 20×30, 30×40 mm), resorption time (12 weeks), sterilization method (ethylene oxide), shelf life (3 years), and operating principles (cell-occlusive, implantable, resorbable, biocompatible).
ASTM F1980, ISO 11607-1, ISO 11607-2, ASTM D7386, ISO 11135, ISO 10993-1, ISO 10993-5, ISO 10993-17, ISO 10993-18, ISO 22442-3, and ASTM F2212.
The subject device has identical intended use, indications for use, materials, design, sterilization method, and operating principles as the predicate device (K173562). Performance and biocompatibility testing demonstrate it is as safe and effective as the predicate and raises no new questions of safety or effectiveness.
View the full FDA submission: accessdata.fda.gov