Sterile Collagen Periodontal Membrane - India CDSCO Medical Device Registration

Sterile Collagen Periodontal Membrane is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000502_d8a16055d117c6fd619db12cb48bfa75_4a9c427b50ab2695542904e0208e10f8. This device is marketed under the brand name Biological skin dressing. The license holder is SynerHeal Pharmaceuticals, and it is classified as Device Class Class D. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class D

Sterile Collagen Periodontal Membrane

UID: MFG/MD/2022/000502_d8a16055d117c6fd619db12cb48bfa75_4a9c427b50ab2695542904e0208e10f8

Brand Name

Biological skin dressing

License Holder

SynerHeal Pharmaceuticals

Device Class

Class D

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

Fix Gide GTR is intended for use in oral surgical procedures as a resorbable membrane for: • Use in augmentation around implants placed in immediate and delayed extraction sockets • Localized ridge augmentation for later implantation • Alveolar ridge reconstruction for prosthetic treatment • Filling of bone defects • Guided bone regeneration in dehiscence defects • Guided tissue regeneration procedures in periodontal defects • Cleft closure surgeries Fix Gide GTR should be used in combination of void filling bone-graft material such as autologous bone or bone substitutes (Biological skin dressing) whenever possible