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Dental soft tissue indications: incision, vaporization, ablation, and coagulation of oral soft tissues including the following: - · Gingival troughing for crown impression - · Gingivectomy - · Gingivoplasty - · Gingival incision and excision - · Hemostasis and coagulation - · Excisional and incisional biopsies - · Exposure of unerupted teeth - · Fibroma removal - · Frenectomy and frenotomy - · Implant recovery - · Incision and drainage of abscess - · Leukoplakia - Operculectomy - · Oral papillectomies - · Pulpotomy - Pulpotomy as an adjunct to root canal therapy - · Reduction of gingival hypertrophy - · Soft tissue crown lengthening - · Treatment of canker sores, herpetic and ulcers - · Vestibuloplasty - · Tissue retraction for impression Laser periodontal indications including: · Sulcular debridement (curettage, removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival bleeding index, probe depth, attachment loss, and tooth mobility). · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket.

The Ultrafast series (Ultrafast, Ultrafast Plus, and Ultrafast Lite) are cordless diode laser systems designed for a wide variety of dental soft tissue procedures. The products have three separate models under the model names: Ultrafast, Ultrafast Plus and Ultrafast Lite. They use solid-state laser diodes as sources of infrared radiation. The energy from the infrared radiation is delivered to the treatment site via a single-use fiber optic tip. The product kit consists of a laser handpiece, laser goggles, charging stand, power adapter, laser shield, barrier sleeves, product warning labels and instructions for use. The laser handpiece is constructed from anodized aluminum and contains a single-use, disposable fiber optic tip and main body containing laser diode, main control and a rechargeable battery assembly. The main control houses the control circuitry with microprocessor and user interface to control and deliver the laser and a green aiming beam to guide the laser procedures. The charging stand allows for the placement of the handpiece in a holder with electrical connection to the power adapter as the source for charging the rechargeable battery. Based on the wavelength and power of the laser diodes used, the kit can be preconfigured into three separate models: | Trade Name | Wavelength (nm) | Max CW Power (Watt) | |----------------|-----------------|---------------------| | Ultrafast | 808 | 3 | | Ultrafast Plus | 980 | 3 | | Ultrafast Lite | 808 | 1.5 |

Source of illumination for curing photo-activated dental restorative materials and adhesives.

Fusion Plus Curing Light is a portable dental LED curing light system. It provides a source of illumination for polymerization of photo-activated dental materials. The principle of operation is the same as the predicate devices: illumination for polymerization or curing of photo-activated dental materials. It uses our patented Fusion optical technology in combination with high-power LED to deliver high efficiency and high-power curing light. The system consists of a curing handpiece, a charging stand, 100 barrier sleeves, light shields, a power adapter, and instructions for use. The handpiece is constructed of aluminum and consists of a main control, a light head, and a rechargeable battery assembly. The main control houses the control circuitry with microprocessor and user interface consisting of LCD display and two control buttons. A mode button selects operation timer and two curing modes: plasma or pulse mode. A ON/OFF button activates and deactivates the light. The handpiece is non-sterile utilizing the barrier sleeves for infection control. Similar to the predicate devices, the light shield and curing cap absorb emitted light and perform the function of eye protection. The charging stand allows for the placement of the handpiece in a holder with electrical connection to the power adapter as the source for charging the rechargeable battery. FUSION Plus has an interchangeable LED light head. Depending on the light head connected with the main control or added later, the kit can be configured in three options: Trade Name: FUSION Plus, LED Peak Wavelength (nm): 395-480 Trade Name: FUSION Plus Standard, LED Peak Wavelength (nm): 440-480 The instructions for use detail the use of each head in curing of dental materials.

Dentlight Oral Exam Light Kit is indicated to be used by a dentist and physician for illumination to aid visualization during oral procedures and as an adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions.

Dentlight Oral Exam Light Kit is a rechargeable-battery-powered cordless unit designed for illumination and examination for dental and physician's office on any procedures which require a small homogenous and well-defined spot and natural tissue reflectance and fluorescence visualization of healthy and abnormal tissue. Dentlight Oral Exam Light Kit consists of a cordless unit with interchangeable light head (White and Violet), custom adaptable Fluorescence Loupe Filters and Filter Caps, Charging Stand, Power Adapter, and Patient Protective Eyewear Goggle.

The FUSION Curing Light is a dental curing light that is intended for photopolymerization of dental resins, restorative composite materials, and orthodontic brackets, bonding, and sealing that are photo-polymerized in the 440 – 480 nm wavelength range.

The DentLight's FUSION Curing Light is a battery-powered cordless unit designed for curing VLC materials whose initiator systems are sensitive to light in the 440-480nm wavelength range of the visible spectrum. The unit is based on blue LED (light emitting diode) technology for light generation in the desired wavelength and Li-Ion rechargeable batteries. The FUSION Curing Light includes: - A handpiece with a focusing lens focusing light emitted from a single LED probe tip and controlled by built-in control electronics - · A detachable rechargeable battery unit - · A base unit that plugs into main power as the handpiece stand - · An eye shield and disposable cap at probe tip - · Disposable disinfectant barrier sleeves on the probe tube