Dental root canal filling material - India CDSCO Medical Device Registration

Dental root canal filling material is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000674_8c26d0d798ac1ef4d873e6b51fc1f61a_6558d8739b39909d6032f736f787353b. This device is marketed under the brand name NISHIKA CANAL SEALER BG multi. The license holder is Parekh Integrated Services Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Dental root canal filling material

UID: IMP/MD/2023/000674_8c26d0d798ac1ef4d873e6b51fc1f61a_6558d8739b39909d6032f736f787353b

Brand Name

NISHIKA CANAL SEALER BG multi

License Holder

Parekh Integrated Services Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Calcipex II can be applied to the following cases. 1. For the treatment of infected root canals and these that accompany constant effusion or continuous percussion pain 2. For post-extirpation of pulp 3. As a temporary root canal dressing for; a) The cases with large periapical lesion b) Incomplete root teeth c) Implanted, reimplanted and traumatic teeth d) Perforated, fractured teeth 4. As a root canal filling of deciduous teeth 5. For pulp capping of vital pulpotomy 6. For temporary pulp capping of exposed pulp