Profile: Zimmer Dental, Inc. specializes in dental implant products. Our product portfolio comprises of root-form endosseous dental implants, prosthetic attachments for restoration, surgical instrumentation, collagen-based wound healing and regenerative products, as well as bone graft products. Our tapered screw-vent implant system has multi-lead threads, tapered bodies, and soft & dense bone surgical protocols. On its insertion into a straight, undersized osteotomy, the bone is compressed resulting in enhanced primary stability. Its tapered body also facilitates implant placement between convergent roots, in areas with labial concavities and in immediate extraction sites. Our proprietary friction-fit internal hex connection is a combination of designs that reduce stress on crestal bone and resist abutment screw loosening, thereby maintaining appropriate bone level.

The company was founded in 1927, has revenues of USD 100-500 Million, has ~410 employees and is ISO 13485, CE certified. NYSE:ZMH (SEC Filings)

FDA Registration Number: 2023141

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• Multiple Component Fixation Appliance (FDA Code: KTT / 888.3030) Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Nail Extractors (FDA Code: HWB / 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/Blade/Plate Component Fixation Appliance (FDA Code: LXT / 888.3030)

• Nasal Splints (FDA Code: EPP / 874.5800) An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.

• Neurological Endoscope (FDA Code: GWG / 882.1480) A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

• Neurological Stereotaxic Instrument (FDA Code: HAW / 882.4560) A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

• Neurology Self-Retaining Retractor (FDA Code: GZT / 882.4800) A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.

• Non-Invasive Tubing (FDA Code: GAZ / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Non-Powered Dynamometer (FDA Code: HRW / 888.1250) A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength of a patient's hand.

• Non-Powered Goniometer (FDA Code: KQW / 888.1520) A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.

• Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY / 878.4680) A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.

• Non-Powered Surgical Instrument (FDA Code: HAO / 882.4535) A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.

• Non-Powered Traction Apparatus (FDA Code: HST / 888.5850) A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.

• Non-Sterile External Non-Inflatable Extremity Splint (FDA Code: NOC / 878.3910) A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.

• Nonresorbable Gauze/sponge for External Use (FDA Code: NAB / 878.4014) A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

• Nut Bolt Washer (FDA Code: HTN / 888.3030)

• Operating-Room Table and Attachments (FDA Code: BWN / 878.4950) A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

• Orthopedic Burr (FDA Code: HTT / 888.4540)

• Orthopedic Cutting Instrument (FDA Code: HTZ / 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.

• Orthopedic Elevator (FDA Code: HTE / 878.4800)

• Orthopedic Knife (FDA Code: HTS / 888.4540)

• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)

• Orthopedic Needle Holder (FDA Code: HXK / 888.4540)

• Orthopedic Osteotome (FDA Code: HWM / 878.4800)

• Orthopedic Wire Passer (FDA Code: HXI / 888.4540)

• Overhead Supported Arm Sling (FDA Code: ILE / 890.3475) A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

• Passer (FDA Code: HWQ / 888.4540)

• Patellofemorotibial Knee Prosthesis (FDA Code: MBH / 888.3565) A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

• Patient Position Support (FDA Code: CCX / 868.6820) A patient position support is a device intended to maintain the position of an anesthetized patient during surgery.

• Pelvic Traction Belt (FDA Code: HSQ / 888.5890) A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body.

• Periodontal Probes

• Peristaltic Infusion Pump (FDA Code: FRN / 880.5725) An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

• Pin Crimper (FDA Code: HXQ / 888.4540)

• Pin Surgical Driver (FDA Code: GFC / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• Pneumatic Powered Orthopedic Surgical Instrument & Accessory (FDA Code: HSZ / 878.4820)

• Pneumatic Tourniquet (FDA Code: KCY / 878.5910) A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.

• Polymer Radial Hemi- Elbow Prosthesis (FDA Code: KWI / 888.3170) An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.

• Probes (FDA Code: HXB / 888.4540)

• Probes (FDA Code: HXB / 888.4540)

• Processed Allograft

• Prosthesis Driver (FDA Code: HWR / 888.4540)

• Protractor (FDA Code: HTH / 888.4600) A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on x-rays or in surgery.

• Proximal Femoral Fixation Implant Device (FDA Code: JDO / 888.3030)

• Reamer (FDA Code: HTO / 888.4540)

• Removable Skin Clip (FDA Code: FZQ / 878.4320) A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.

• Resurfacing Femoral Hip Prosthesis (FDA Code: KXA / 888.3400) A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.

• Rib Rongeurs (FDA Code: HTX / 888.4540)

• Ruler and Caliper (FDA Code: FTY / 878.4800)

• Saws (FDA Code: HSO / 878.4800)

• Scalpel Handle (FDA Code: GDZ / 878.4800)