Profile: Nobel Biocare specializes in dentistry related products. Our product categories are implants & abuttments, individualized prosthetics, and digital dentistry. Our NobelActive™ has been designed for maximum restorative flexibility, and is comprised of an internal conical connection for single abutments & an external platform for implant-level bridge restorations. Our NobelReplace™ patered implant system has features such as color coding for identification of components, step-by-step drilling protocol for predictable surgical procedures and internal tri-channel connection for prosthetic restorations.
FDA Registration Number: 2027971
10 Products/Services (Click for related suppliers)
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• Bone Clamp (FDA Code: HXD / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
• General Surgery Tray (FDA Code: LRO / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy. |
• Impactor (FDA Code: HWA / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench. |
• Nail Extractors (FDA Code: HWB / 888.4540) |
• Prosthetic Devices |
• Reamer (FDA Code: HTO / 888.4540) |
• Screwdriver (FDA Code: HXX / 888.4540) |
• Surgical Instrument Tray (FDA Code: FSM / 878.4800) |
• Surgical Punch (FDA Code: LRY / 878.4800) |
• Wrench (FDA Code: HXC / 888.4540) |