Spongious Bone Substitute - India CDSCO Medical Device Registration

Spongious Bone Substitute is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000069_b666f6da9aea2f4ab8f8674080ee41ce_deb57977d5bc894fbfd7630f8a43e7dc. This device is marketed under the brand name Geistlich Bio-Gide. The license holder is M/s Geistlich Pharma India Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Spongious Bone Substitute

UID: IMP/MD/2019/000069_b666f6da9aea2f4ab8f8674080ee41ce_deb57977d5bc894fbfd7630f8a43e7dc

Brand Name

Geistlich Bio-Gide

License Holder

M/s Geistlich Pharma India Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

Geistlich Bio-Oss® is intended to be used in the treatment of hard tissue defects in oral-maxillofacial surgery,collagen matrix(Geistlich Bio-Gide)-Geistlich Bio-Oss® Collagen is intended for reconstruction of bone defects in maxillofacial surgery and in dental surgery, e.g.: • Augmentation/reconstruction of alveolar ridges • Filling of extraction sockets • Implantology: preparation of implant sites, filling of bone dehiscences, and sinus floor augmentations • Periodontology: filling of bone defects, support of the membrane during guided bone regeneration (Geistlich Bio-Gide) and guided tissue regeneration (Geistlich Bio-Gide) Geistlich Bio-Gide is intended to be used as a barrier membrane in the regeneration of bone defects. Geistlich Bio-Gide® is used after bone grafting procedures and to enhance soft tissue formation, e.g. in • GBR (Geistlich Bio-Gide) procedures • Immediate or delayed augmentation around implants placed in extraction sockets • Reconstruction of the alveolar ridge • Filling of bone defects in the maxillofacial area • Cleft closure surgeries