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The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used.

The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used. The 430 SWL 45 and 430 SW 45 High-Speed Handpieces are designed with a 45 degree back angled head to facilitate access to the back of the oral cavity. They are designed so that air that expelled from the head of the handpiece is directed out the side of the handpiece head and not directed onto the work area of the bur. The handpieces are intended for use with a friction grip bur that conforms to ISO 1797-1 standards. Recommended air pressure is 30-34 PSI which results in a bur rotation of approximately 400,000 RPM. The 430 SWL 45 High-Speed Handpiece is a fiber optic, swivel connector type handpiece with a lubefree, ceramic bearing, push button autochuck turbine. The 430 SW 45 High-Speed Handpiece is a non-fiber optic version of the 430 SWL 45 Handpiece.

The NuTorque Programmable Electric System is used by trained dental professionals to perform general dental procedures including crown preparation, cavity preparation, crown finishing, inlay and the filling, polishing, prophylaxis and endodontic treatment.

The NuTorque Programmable Electric System is an electric handpiece system for use in performing various dental procedures including grinding and trimming. post and pin drilling, pin setting, finishing, polishing, endodontic, caries removal and prophylaxis. The NuTorque Programmable Electric System is composed of a power supply. control unit, cable and brushless micromotor. The control unit controls the torque, speed and directional rotation of the motor. The system is programmed through the use of a color touch screen on the control unit. The motor has a rotational speed of 100- 40,000 rpm's and can be operated in a clockwise or counterclockwise direction. The system also provides variable light intensity to the handpiece.

High speed handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. The intended use of this device is identical to the predicate 430 series handpiece currently marketed under 510(k) numbers K960719 and K982593.

The Solara Series High Speed Dental Handpieces are pneumatically driven, handheld devices intended for use by trained dental professionals for drilling in the oral cavity. Procedures include but not limited caries removal, restorative work and crown preparations.

The Portable HDX Intraoral X-ray unit is intended for use only by a qualified/trained dentist or dental technician on both adult and pediatric subjects for taking diagnostic extraoral dental x-rays using intraoral image receptors.

Portable HDX Intraoral X-ray is a portable dental x-ray system that operates on 120 VAC (+/-10%), 60 Hz, and 240 VAC (+/-10%), 50 Hz line AC power. The system uses Constant Emission Power (CEP) which allows for minimum exposure time and can be either mounted to a tripod or can be hand held.

The Air Controlled Sterile Irrigation System is used intra-orally by trained dental professionals for delivery of sterile water for oral surgical procedures as a replacement irrigating solution to the dental operative unit's water supply, specifically for cooling a dental rotary instrument.

The StarDental® Air Controlled Sterile Irrigation System is used intra-orally by trained dental professionals for delivery of sterile water for oral surgical procedures as a replacement irrigating solution to the dental operative unit's water supply, specifically for cooling a dental rotary instrument. The Air Controlled Sterile Irrigation System consists of a connector assembly and pinch valve assembly which can be autoclaved.

Low speed dental attachments are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. Furthermore, the intended use extends to disking, cavity and crown preps, polishing, post and pin drilling and pin setting. The intended use is identical to that of the predicate low speed motor attachments.

Dental attachments and accessories to be used by the dental clinician during routine dental procedures. The attachments affix to a low speed dental motor.

High-speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental caries for restoration, such as fillings. The intended use is identical to that of the predicate 430 Series Lube Free High Speed Handpiece. Autochuck turbines are used in place of a bur tool to facilitate bur changing. The intended use of the Star Autochuck Turbine with Vortex Air Seal is to both provide the convenient:e of tool-free bur changing and to eliminate the necessity of lubrication of the turbin a after use and before sterilization.

Lube Free Autochuck Turbine with Vortex Air Seal for use with StarDental 430 Series Lube Free High Speed Dental Handpiece. Autochuck turbines are used in place of a bur tool to facilitate bur changing.

Air powered low speed dental motor that powers various dental attachments and accessories to facilitate procedure by the dental clinician during routine dental procedures.

Air powered low speed dental motor that powers various dental attachments and accessories to facilitate procedure by the dental clinician during routine dental procedures.

Both the predicate turbines and the proposed Star Dental replacement turbines are intended to be used as components to high speed handpieces, which are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.

Star Dental Pushbutton Autochuck Replacement Turbine.

High speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. The intended use of the device is identical to that of the predicate.

High speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. The technology, design, manufacturing, and materials are substantially equivalent to those of other handpieces on the market, including that of the current 430 series handpiece.