Dental Abutment Design Software for Dental Laboratory - India CDSCO Medical Device Registration

Dental Abutment Design Software for Dental Laboratory is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001160_c9fbbe683195916fdf5056ebbe62ee93_d03ebdc0b607c12a5f895fdc66954284. This device is marketed under the brand name DTX Studio™ Implant. The license holder is NOBEL BIOCARE 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

Dental Abutment Design Software for Dental Laboratory

UID: IMP/MD/2023/001160_c9fbbe683195916fdf5056ebbe62ee93_d03ebdc0b607c12a5f895fdc66954284

Brand Name

DTX Studio™ Implant

License Holder

NOBEL BIOCARE INDIA PVT LTD

Device Class

Class C

Approving Authority

CDSCO

Product Information

DTX Studio™ Lab is intended as an aid to the restoration of chewing function and/or esthetics in partially or fully edentulous mandibles and maxillae. The software is intended to be used by a dental technician for receiving or acquiring patient-specific data from surface scanners. The software is intended to be used for designing the patient-specific component of a two-piece, one-piece or hybrid dental implant abutment, for designing a prosthetic restoration and for designing a dental appliance. The resulting output file contains the dental restoration design in a digital form and can be used with 3D manufacturing systems. The software also serves as a means of creating, ordering and managing cases.