Dental Instruments and Surgical Kits - India CDSCO Medical Device Registration
Dental Instruments and Surgical Kits is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000256_1cf2f72588e23daa66a65fd8348b61fa_37b6ad45d3c7715bfed4979a295c6261. This device is marketed under the brand name BIOMET 3i. The license holder is ZB Dental India Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
BIOMET 3i
License Holder
ZB Dental India Pvt LtdDevice Class
Approving Authority
CDSCO
Product Information
Dental Instruments are intended to facilitate the implantation and explantation of the corresponding Dental Implants, and for use as accessories to dental restorative and laboratory components. Osteotomes hand-held, dental, surgical instruments used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. Tissue punches are dental instruments used to remove with precision a circular area of gum tissue during dental surgery, to allow access to a site for drilling and dental implant placement without the use of a scalpel. Implant Analogs and Abutment Analogs represent implants and abutments in a preoperative cast. Polishing Protectors protect abutments during polishing. The Screw Removal Tool Kits facilitate the removal of a broken screw from the internal threads of Certain and External Hex Implants in the unlikely event of a screw fracture below the occlusal surface of the implant. Biomet 3i Class IIa Active Dental Instruments & Kits include devices such as drills, taps, drivers, profilers, burs, and bone profilers that are attached to a surgical drilling unit or intermediary device to prepare an osteotomy for dental implant placement. Sterile devices are intended to be used as tools in standard dental procedures associated with dental implants, restorative components, and associated laboratory procedures. These tools are used toper form a wide variety of relatively simple, non-active, non-measuring functions. They are used throughout dental and oral/maxillofacial procedures. Biomet 3i Class IIa Active Dental Instruments & Kits include devices such as drills, taps, drivers, profilers, burs, and bone profilers that are attached to a surgical drilling unit or intermediary device to prepare an osteotomy for dental implant placement.
Dental Implant Abutments
Brand: LOCATOR Implant
Resorbable Collagen Membrane
Brand: OsseoGuard
Resorbable Collagen Membrane for Dental Surgery
Brand: OsseoGuard
Zfx GenTek Restorative Components
Brand: Zfx GenTek TiBase & Zfx GenTek Pre-milled Abutment Blank
Synthetic Mineral-Collagen Composite Bone Graft
Brand: RegenerOss Resorbable Xenograft Syringe
Absorbable Wound Dressings for Dental Surgery
Brand: RegenerOss Resorbable Xenograft Syringe
RegenerOss Resorbable Xenograft
Brand: RegenerOss Resorbable Xenograft Syringe
RegenerOss Resorbable Xenograft Syringe
Brand: RegenerOss Resorbable Xenograft Syringe
Dental Restorative Devices- Screw
Brand: 3i T3, OSSEOTITE, 3i T3 Short Implants, Certain, PREVAIL, DCD
Dental Restorative Devices
Brand: 3i T3, OSSEOTITE, 3i T3 Short Implants, Certain, PREVAIL, DCD

