Resorbable calcium salt bone void filler device
- UID
- IMP/MD/2020/000228_1b2a6d0139ffb64d3d3cbddf95fddebd_0f5cf3f78a0f44ad176f926504954510
- Device class
- Class C
- Brand name
- GRAFTON DBM Putty
- Approving authority
- CDSCO
- Product information
- GRAFTON™ DBM and GRAFTON PLUS™ DBM are intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (GRAFTON DBM Putty) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. GRAFTON™ DBM (GRAFTON DBM Putty) and GRAFTON PLUS™ DBM are also intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral, and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (GRAFTON DBM Putty); dental extraction sites (GRAFTON DBM Putty); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON™ DBM and GRAFTON PLUS™ DBM may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (GRAFTON DBM Putty), or they may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON™ DBM and GRAFTON PLUS™ DBM are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON™ DBM and GRAFTON PLUS™ DBM are absorbed/remodeled and replaced by host bone during the healing process. Note: The user should consider the fact that GRAFTON™ DBM CRUNCH contains demineralized bone chips approximately 3 mm (GRAFTON DBM Putty) in determining the appropriateness of this allograft for use in small defects.
Resorbable calcium salt bone void filler device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000228_1b2a6d0139ffb64d3d3cbddf95fddebd_0f5cf3f78a0f44ad176f926504954510. This device is marketed under the brand name GRAFTON DBM Putty. The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.
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