Orthodontic Adhesive and Bracket & Tooth Conditioner - India CDSCO Medical Device Registration

Orthodontic Adhesive and Bracket & Tooth Conditioner is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000517_a66051df833425d35ca0617bdb173d46_ce461e8de34ab6da0aed71cef657c457. This device is marketed under the brand name Transbond XT Light Cure Adhesive and Transbond XT Primer. 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

Orthodontic Adhesive and Bracket & Tooth Conditioner

UID: IMP/MD/2023/000517_a66051df833425d35ca0617bdb173d46_ce461e8de34ab6da0aed71cef657c457

Brand Name

Transbond XT Light Cure Adhesive and Transbond XT Primer

License Holder

3M India Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

3M Unitek products are intended for use during orthodontic treatment of malocclusions (Transbond XT Light Cure Adhesive and Transbond XT Primer).The orthodontic bonding process typically involves 3 steps: etching, priming, and application of adhesive and bracket. The first step is etching the tooth with a phosphoric acid solution, which creates very fine spaces in the enamel surface. The second step is application of a primer to the tooth. The primer penetrates the enamel rods in the tooth and provides a substrate onto which the adhesive will bond to the tooth. The third step is the application of the adhesive on the bracket base, which is then placed onto an etched and primed tooth.Transbond XT Adhesive is designed for direct bonding of ceramic orthodontic brackets and metal brackets. Transbond XT Adhesive is not indicated for use with plastic (Transbond XT Light Cure Adhesive and Transbond XT Primer) brackets