Universal Adhesive - India CDSCO Medical Device Registration

Universal Adhesive is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000614_1942bbbea9f42b4dff3e300a5b6539ab_22ffd761187e3b921ffd22681f1f5f0f. This device is marketed under the brand name Dyract eXtra/Dyract XP . The license holder is M/s Dentsply India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Universal Adhesive

UID: IMP/MD/2022/000614_1942bbbea9f42b4dff3e300a5b6539ab_22ffd761187e3b921ffd22681f1f5f0f

Brand Name

Dyract eXtra/Dyract XP

License Holder

M/s Dentsply India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Direct, light cured composite and compomer restorations; Light cured resin cemented veneers; Composite, ceramic and amalgam repairs; Cavity varnish for use with fresh amalgam; Indirect restorations and endodontic posts cemented with Calibra® Ceram In combination with Dentsply Sirona Self Cure Activator: • Direct dual cure/self cure composite restorations and core build-ups. • Cementation of indirect restorations and endodontic posts using dual cure/self cure resin cements

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Zinc Phosphate Cement

Brand: Dyract eXtra/Dyract XP

M/s Dentsply India Pvt. Ltd.

Universal Adhesive - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Zinc Phosphate Cement

Flowable Composite Restorative

Fast-Setting Glass Ionomer Restorative Material

The Caries Preventing Restorative

Universal Composite Restorative-- Direct restorations of all cavity classes in anterior and posterior teeth.

Nano-Technology Dental Adhesive

Zinc Polycarboxylate Cement

Universal microhybrid composite restorative

Root Canal Sealer

SICAT IMPLANT Software

MGUIDE insertion tool

Body try in/depth probe

Tissue punch

Parallel pins

Caps (Caps )

Stopper for drill

MGUIDE Tissue punch

Position drill

MGUIDE Bone mill drill