BIOMET 3i Dental Implant - India CDSCO Medical Device Registration

BIOMET 3i Dental Implant is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000256_12a08ec8d2fc2d7bb0762cb393c84725_63de543c2936e9aff15993c12ad216b3. This device is marketed under the brand name 3i T3, OSSEOTITE, 3i T3 Short Implants, Certain, PREVAIL, DCD. The license holder is ZB Dental India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

BIOMET 3i Dental Implant

UID: IMP/MD/2021/000256_12a08ec8d2fc2d7bb0762cb393c84725_63de543c2936e9aff15993c12ad216b3

Brand Name

3i T3, OSSEOTITE, 3i T3 Short Implants, Certain, PREVAIL, DCD

License Holder

ZB Dental India Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

BIOMET 3i™ Dental Implants, including the BIOMET 3i T3®, OSSEOTITE® and 3i T3® Short Implants, are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. The BIOMET 3i T3® and OSSEOTITE® Dental Implants may also utilize immediate loading for these indications. BIOMET 3i T3® and OSSEOTITE® Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function