Acteon Inc.

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Contact: Mr. Wyatt Wilson - National Sales Manager
Web: http://www.acteongroup.com
E-Mail:
Address: 124 Gaither Drive, Suite 140, Mount Laurel, New Jersey 8054, USA
Phone: +1-(856)-222-9988, 800-289-6367 | Fax: +1-(856)-222-4726 | Map/Directions >>

Profile: Acteon Inc. provides a wide range of dental equipment including air polishers, intra-oral camera systems, LED curing lights, piezo ultrasonic units, and OEM technology. The implant center combines the ultrasonic and motor technologies for pre-implant & implant surgery, and implant maintenance. It features high & stable motor torque, even at low speed, and effortless cut with respect to soft tissues, and fast healing in piezotome mode. The Piezotome is a piezoelectric ultrasonic generator for pre-implant and periodontal surgery. It is designed for delicate procedures such as osteotomy, osteoplasty, ridge expansion, sinus lift, and syndesmotomy. The X-Mind® AC generator is fitted with a Toshiba DG-073B monophased auto rectifier tube. It generates a high 70kV voltage with an ideal intensity of 8mA. It offers concentrated, high density radiation in a very small diameter focal spot (0.7mm) for accuracy. Supplied with a long cone as standard, the generator is suited to the parallel technique (a short cone and a rectangular cone are available as options). The rays emitted have a large wavelength and provide pictures characterized by a widespread gray scale for distinction of anatomical detail.

The company was founded in 1946, has revenues of USD 50-100 Million, has ~650 employees and is ISO 9001, CE certified.

FDA Registration Number: 2243757

32 Products/Services (Click for related suppliers)

• AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE / 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.

• Active Electrosurgical Electrode (FDA Code: FAS / 876.4300)

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

• Arthroscopes (FDA Code: HRX / 888.1100)

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

• Biopsy Forceps Cover (FDA Code: FFF / 876.1075)

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Cystoscopic Scissors (FDA Code: KGD / 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.

• Digital Extraoral Source X-ray System (FDA Code: MUH / 872.1800)

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

• Electric ENT Surgical Drill (FDA Code: ERL / 874.4250)

An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.

• Endoscope Accessories (FDA Code: KOG)

• Endoscopic Access Overtube (FDA Code: FED / 876.1500)

• Endoscopic Obturator (FDA Code: FEC / 876.1500)

• Endoscopic Photographic Accessories (FDA Code: FEM / 876.1500)

• Endoscopic Television Camera without Audio (FDA Code: FWF / 878.4160)

A surgical camera and accessories is a device intended to be used to record operative procedures.

• Fiberoptic Retractor (FDA Code: FDG / 876.4530)

A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites.

• Flexible/Rigid Bronchoscope (FDA Code: EOQ / 874.4680)

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

• Flexible/Rigid Cystoscope and Accessories (FDA Code: FAJ / 876.1500)

• 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)

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 & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500)

• Hysteroscope and Accessories (FDA Code: HIH / 884.1690)

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

• Laparoscopic Insufflation Tubing/Tubing With Filter (FDA Code: NKC / 884.1730)

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

• Laparoscopic Insufflator (FDA Code: HIF / 884.1730)

• Mechanical Urethral Dilator (FDA Code: FAH / 876.5520)

A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.

• Metal Ureteral Basket Stone Dislodger (FDA Code: FFL / 876.4680)

A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

• Otoscopes (FDA Code: ERA / 874.4770)

An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.

• Resectoscope Working Element (FDA Code: FDC / 876.1500)

• Resectoscopes (FDA Code: FJL / 876.1500)

• Rigid Laryngoscope (FDA Code: CCW / 868.5540)

A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

• Simple Powered Trephines & Accessories (FDA Code: HBE / 882.4310)

Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

• Solid State X-Ray Imager (FDA Code: MQB / 892.1680)

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Sonic Surgical Instrument and Accessory (FDA Code: JDX / 888.4580)

A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.

• Steam & Ethylene-Oxide Bulk Sterilizer

• Urethrotome (FDA Code: EZO / 876.4770)

A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control.