Pure Global

Bioactive dentine - India CDSCO Medical Device Registration

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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class B
Bioactive dentine
UID: IMP/MD/2023/000644_7ce667091d7f4429377940280317453d_608b2b902b72f85f2d34e68169cc3ac7

Brand Name

BIOROOT RCS

Device Class

Class B

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.

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Similar Products (1)
Other products with the same name or brand