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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• Cast Shoe (FDA Code: IPG / 890.3025) A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.

• Catheter Tip Blood Pressure Transducer (FDA Code: DXO / 870.2870) A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.

• Cement Dispenser (FDA Code: KIH / 888.4200) A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.

• Cement Mixing Equipment (FDA Code: JDZ / 888.4210) A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (888.3027).

• Cement Monomer Vapor Evacuator (FDA Code: JDY / 888.4220) A cement monomer vapor evacuator is a device intended for use during surgery to contain or remove undesirable fumes, such as monomer vapor from bone cement (888.3027).

• Cement Obturator (FDA Code: LZN / 878.3300) Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

• Cement Restrictor Hip Prosthesis (FDA Code: JDK / 878.3300)

• Cement Ventilation Tube (FDA Code: KII / 888.4230) A cement ventilation tube is a tube-like device usually made of plastic intended to be inserted into a surgical cavity to allow the release of air or fluid from the cavity as it is being filled with bone cement (888.3027).

• Cemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: JDI / 888.3350) A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (888.3027).

• Cemented/Uncemented Semi-constrained Hip Prosthesis (FDA Code: MRA)

• Ceramic Component

• Cerclage Applier (FDA Code: HXN / 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.

• Cervical Orthosis (FDA Code: IQK / 890.3490) A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

• Chisel/Osteotome (FDA Code: KDG / 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.

• Clavicle Splint (FDA Code: IQJ / 890.3490)

• Clip Surgical Applier (FDA Code: GDO / 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.

• Collagen-Based Absorbable Hemostatic Agent (FDA Code: LMF / 878.4490) An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.

• Composite/Metal Semi-Constrained Hip Prosthesis (FDA Code: KMC / 888.3340) A hip joint metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace a hip 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 includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high molecular weight polyethylene with carbon fibers composite. Both components are intended for use with bone cement (888.3027).

• Compression Instrument (FDA Code: HWN / 888.4540)

• Condylar Plate Fixation Device Implant (FDA Code: JDP / 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.

• Congenital Hip Dislocation Abduction Splint (FDA Code: IOZ / 890.3665) A congenital hip dislocation abduction splint is a device intended for medical purposes to stabilize the hips of a young child with dislocated hips in an abducted position (away from the midline).

• Constrained Elbow Prosthesis (FDA Code: JDC / 888.3150) An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).

• Corkscrew (FDA Code: HWI / 888.4540)

• Countersink (FDA Code: HWW / 888.4540)

• Curettes (FDA Code: HTF / 878.4800)

• Denis Brown Splint (FDA Code: ITN / 890.3675) A Denis Brown splint is a device intended for medical purposes to immobilize the foot. It is used on young children with tibial torsion (excessive rotation of the lower leg) or club foot.

• Depth Gauge (FDA Code: HTJ / 888.4300) A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.

• Dermatomes (FDA Code: GFD / 878.4820)

• Disposable Hot/Cold Pack (FDA Code: IMD / 890.5710) A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

• Disposable Medical Scissors (FDA Code: JOK / 880.6820) Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical scissors.

• Drill Bit (FDA Code: HTW / 888.4540)

• Drill Brace (FDA Code: HXY / 888.4540)

• Drill Handpiece (Brace) (FDA Code: HBD / 882.4325) A cranial drill handpiece (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting tools that are used on a patient's skull.

• Elastic Bandages (FDA Code: FQM / 880.5075) An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Endoscope Accessories (FDA Code: KOG)

• Endoscopic Photographic Accessories (FDA Code: FEM / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• External Ankle Brace (FDA Code: ITW / 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.

• External Brace Hip Joint (FDA Code: ITS / 890.3475)

• External Brace Knee Joint (FDA Code: ITQ / 890.3475)

• Femoral Neck Punch (FDA Code: HWP / 888.4540)

• Fiberoptic Surgical Light (FDA Code: FST / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

• Files (FDA Code: HTP / 888.4540)

• Fixation Cerclage (FDA Code: JDQ / 888.3010) A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

• Flexible Depth Gauge (FDA Code: HTJ / 888.4300)

• Flexible/Rigid Nasopharyngoscope (FDA Code: EOB / 874.4760) A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

• Forceps (FDA Code: HTD / 878.4800)

• Fork (FDA Code: HXE / 888.4540)

• Gas Cylinder Pressure Regulator (FDA Code: CAN / 868.2700) A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

• General & Plastic Saw Surgical Blade (FDA Code: GFA / 878.4820)