Bone Substitute - India CDSCO Medical Device Registration
Bone Substitute is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000040_30ca4ecd871b923729b07ffa6d1228d6_a4c0a19566a7f839ec4817bb9ead3433. This device is marketed under the brand name SmartBone. The license holder is MEDENTIS DENTAL SOLUTIONS INDIA PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
SmartBone
License Holder
MEDENTIS DENTAL SOLUTIONS INDIA PRIVATE LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
Smartbone® is intended for use for bone regeneration in dental applications, in the following indications: -Regeneration of periodontal bone defects; -Regeneration of extraction alveoli; -Regeneration of cavities between the alveolar wall and immediate implants; -Horizontal alveolar ridge augmentation; -Sinus lift floor elevation; -Alveolar ridge augmentation at implant sites with sufficient residual bone and a good blood supply.
