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ORAL MAXILLOFACIAL IMPLANTS - India CDSCO Medical Device Registration

ORAL MAXILLOFACIAL IMPLANTS is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000196_be3b317fb5cd76a392e441d52c5ecde4_6f2760b8072a6f021f4c2c6cf0a03d20. This device is marketed under the brand name SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES. The license holder is DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered
Class Class C
ORAL MAXILLOFACIAL IMPLANTS
UID: MFG/MD/2019/000196_be3b317fb5cd76a392e441d52c5ecde4_6f2760b8072a6f021f4c2c6cf0a03d20

Brand Name

SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

ORAL-MAXILLOFACIAL IMPLANTS ARE INDICATED FOR USE IN FRACTURE FIXATION, MANDIBULAR RECONSTRUCTION AND SURGERY INVOLVING OSTEOTOMIES, ORTHOGNATHIC RECONSTRUCTION OR SURGERY, SURGERY RELATED TO DENTO-FACIAL OR FACIAL CAVITY AND TRAUMA DUE TO IT. THE INTENDED USE OF THESE IMPLANTS IS TO DRAW TWO OR MORE ALIGNED BONE FRAGMENTS TOGETHER TO FACILITATE HEALING

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