Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®

Geistlich Bio-Oss® is a biocompatible bone mineral matrix made from purified bovine bone spongiosa, supplied as sterile granules or blocks. Geistlich Bio-Oss Pen® is a pre-filled syringe applicator containing the same granules. Both are intended for dental bone grafting applications including alveolar ridge augmentation, periodontal defect filling, sinus floor elevation, and guided bone/tissue regeneration procedures.

The subject devices are identical to the predicate devices in material composition, form (granules or blocks), particle sizes (0.25–1.0 mm and 1.0–2.0 mm), block dimensions (1 × 1 × 2 cm), single-use packaging, and sterilization methods (gamma and X-ray). Both have identical final product specifications and indications for use.

ISO 22442-1:2020, ISO 22442-2:2020, ISO 22442-3:2007 (biological safety of animal-derived materials); ISO 10993-1:2018 (biocompatibility); ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017 (sterilization validation); ISO 11607-1/-2 (packaging).

The subject devices are physically and functionally identical to the predicate devices (K240661 and K120601) with respect to materials, manufacturing, sterilization, packaging, and specifications. The only change is use of an alternate supplier for bovine raw material and non-significant manufacturing facility updates. Performance data leveraged from existing predicate and reference device studies (viral inactivation, biocompatibility, sterilization, shelf-life, and clinical performance) demonstrate that the new raw material supplier does not raise different safety or effectiveness questions. Therefore, the devices are substantially equivalent.