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Adhesive Resin Cement - India CDSCO Medical Device Registration

Adhesive Resin Cement is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000256_31c6fb31d73981517037dbc9f385fdb8_f6c02225e51e75a30a983e96135af5e2. This device is marketed under the brand name Ketac Cem Radiopaque . The license holder is 3M India Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Adhesive Resin Cement
UID: IMP/MD/2023/000256_31c6fb31d73981517037dbc9f385fdb8_f6c02225e51e75a30a983e96135af5e2

Brand Name

Ketac Cem Radiopaque

License Holder

3M India Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Scotchbond Universal Etchant: Etching of enamel and dentin using the acid etching technique RelyX Ultimate Clicker in combination with Single Bond Universal as an adhesive for: Final cementation of all-ceramic, composite, or metal inlays, onlays, crowns and bridges; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges Final cementation of posts and screws Final cementation of all-ceramic, or composite veneers Final cementation of all-ceramic, composite, or metal restorations on implant abutments Indications such as Maryland and inlay/onlay bridges (Ketac Cem Radiopaque ) demand especially high adhesive bond strength. Regardless of the manufacturer of the cement and restoration, these indications may be exposed to a higher risk of decementation. For Resin Nano Ceramic restorations (Ketac Cem Radiopaque ) it is important to maximize bond strength. For the detailed bonding procedure, please refer to the instructions for use of the restoration material

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