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Resorbable calcium salt bone void filler - India CDSCO Medical Device Registration

Resorbable calcium salt bone void filler is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000080_117f57a494d34e63026ef38b54e7b272_6c50e12d077310b81bd3984a7355ca53. This device is marketed under the brand name Mastergraft Granules. 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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CDSCO Registered
Class Class C
Resorbable calcium salt bone void filler
UID: IMP/MD/2020/000080_117f57a494d34e63026ef38b54e7b272_6c50e12d077310b81bd3984a7355ca53

Brand Name

Mastergraft Granules

Device Class

Class C

Approving Authority

CDSCO

Product Information

Dental: MASTERGRAFTยฎ Granules may be used alone or in combination with autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFTยฎ Granules is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Procedures specific to MASTERGRAFT Granules include: โ€ข Filling of dental extraction sockets โ€ข Filling of cystic defects โ€ข Oral/maxillofacial augmentation or reconstruction. Procedures specific to MASTERGRAFT Mini Granules include: โ€ข Filling of periodontal defects โ€ข Sinus lifts โ€ข Alveolar ridge augmentation โ€ข Filling of dental extraction sockets โ€ข Filling of cystic defects โ€ข Oral/maxillofacial augmentation or reconstruction. MASTERGRAFT Granules may be used with or without internal fixation, and may be mixed with autograft as a bone extender

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