Bioactive dentine
- UID
- IMP/MD/2023/000644_7ce667091d7f4429377940280317453d_608b2b902b72f85f2d34e68169cc3ac7
- Device class
- Class B
- Brand name
- BIOROOT RCS
- License holder
- Septodont Healthcare India Private Limited
- Approving authority
- CDSCO
- Product information
- Bioactive dentine substitute. Clinical Performance : 1/ Biodentine has mechanical properties similar to the sound dentine and can replace it both in the crown and in the root, without any preliminary conditioning of mineral tissues 2/ Biodentine contains high-purity, monomer-free mineral ingredients and is highly biocompatible. 3/ Biodentine creates the optimal conditions for maintenance of pulp vitality, by providing a very tight seal on the dentine surface. It therefore reduces the risk of postoperative sensitivity and the longevity of restorations in vital teeth. 4/ Biodentine being bioactive, stimulates the pulp cells to build reactionary dentine. The dentine bridges are created faster and are thicker than with similar dental materials and represent the necessary condition for optimal pulp healing. 5/ Biodentine offers an initial setting time reduced down to 12 minutes from start of mix, for optimal use in the crown.
Bioactive dentine is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000644_7ce667091d7f4429377940280317453d_608b2b902b72f85f2d34e68169cc3ac7. This device is marketed under the brand name BIOROOT RCS. The license holder is Septodont Healthcare India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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