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Root Canal Sealer - India CDSCO Medical Device Registration

Root Canal Sealer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000203_0322b3506194e488d2882672c3fa6c29_eda490721de09fe2e75dfec9426406c1. This device is marketed under the brand name Smart Etch. The license holder is SafeEndo Dental India Pvt Ltd, and it is classified as Device Class Class B. The approving authority is Gujarat.

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.

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CDSCO Registered
Class Class B
Root Canal Sealer
UID: MFG/MD/2023/000203_0322b3506194e488d2882672c3fa6c29_eda490721de09fe2e75dfec9426406c1

Brand Name

Smart Etch

Device Class

Class B

Approving Authority

Gujarat

Product Information

BioActive RCS: Permanent root canal filling in combination with gutta-percha points in vital or necrotic pulp cases or after a retreatment procedure. BioActive RCS is suitable for use in single cone technique or cold lateral condensation. EugeSeal: It is used for the sealing of tooth root canals in the treatment of pulpitis and all forms of Apical Periodontitis. It is recommended to use the sealer in combination with Gutta-Percha points. EpoxySeal: It is used for filling of tooth root canals with gutta-percha points

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