CDSCO UID IMP/MD/2021/000373_1cf2f72588e23daa66a65fd8348b61fa_b85782f42f1f9f11737893108d8445de
Dental Instruments and Surgical Kits
ZB DENTAL INDIA PRIVATE LIMITED·Device Class Class B·India CDSCO·Brand: BIOMET 3i
Registration details
- UID
- IMP/MD/2021/000373_1cf2f72588e23daa66a65fd8348b61fa_b85782f42f1f9f11737893108d8445de
- Device class
- Class B
- Brand name
- BIOMET 3i
- License holder
- ZB DENTAL INDIA PRIVATE LIMITED
- 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 drillingunit 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 to perform 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.
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About this record
Dental Instruments and Surgical Kits is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000373_1cf2f72588e23daa66a65fd8348b61fa_b85782f42f1f9f11737893108d8445de. This device is marketed under the brand name BIOMET 3i. The license holder is ZB DENTAL INDIA PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.
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