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The intended use of DPA is for polishing and cleaning teeth.

Plastic one-piece housing (external casing) with 1 internal drive shaft and a spindle installed and aligned at right angle (90 degree) with each other. The tip of spindle is fitted with rubber prophy cup for cleaning and polishing teeth. A small amount of food-grade grease is added between the drive shaft and the spindle as lubrication. The disposable prophylaxis angle is available in a soft cup and firm cup format, which differ in the material used to form the cup. The Medicom and Practicon brands differ in logo and packaging, but utilize the same design.

The Star E900 Handpiece Series are intended to be used for general dentistry by trained dental professionals. The intended use of the respective handpieces is dependent on the gear ratio. Star E900 1:5 Handpiece: the removal of decayed matter, cavity and crown preparations, the removal of fillings and surface finishing of tooth and restoration surfaces. Star E900 1:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces. Star E900 5:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces. Star E900 1:1 Straight Handpiece: prophylaxis treatment, crown preparations, polishing of tooth and restoration surfaces

The Star E900 Handpiece Series are reusable contra-angle handpieces, driven by an ISO 3964 compliant electric micro-motor or air driven motor, that are intended for use by trained dental professionals in the field of general dentistry. The Star E900 1:5, 1:1 and 5:1 handpieces are designed for general applications to prepare dental cavities for restoration. The Star E900 1:1 Straight Handpiece is designed for prophylaxis treatment, crown preparations, polishing finishing of tooth and restoration surfaces. The Star E900 Handpiece Series feature an ISO 3964 compliant handpiece coupling connecting them to an electric micro-motor controlled by an electric control unit or air driven motor connected to a dental delivery unit. The control unit or delivery unit supplies energy to the handpiece which powers the gears within the handpieces. Depending on the applications, the handpieces have a maximum drive speed of 8,000 to 200,000 RPM's. These handpieces are ergonomically shaped and have glass rod fiberoptics to illuminate the oral cavity during procedures. In addition, the handpieces have multi-port water spray. The exception to the fiber optics and water spray features is the Star E900 1:1 Straight Handpiece. This handpiece does not contain any fiberoptics nor does it have water spray capabilities. All the handpieces in the Star E900 Handpiece series are composed of stainless steel and PEEK. They can be autoclaved. The Star E900 Handpieces use only burs with hardened, tempered steel shanks or carbide shanks which are ISO 1797 compliant. All handpieces in this series incorporate RFID (radio frequency identification) technology. This passive RFID tag does not have a built-in energy source. The RFID tag will allow the practitioner to track the device within the office only if the practitioner has a separate reader. The RFID reader will enable the practitioner to track such things as usage and maintenance. The handpieces, with the exception of the Star E900 1:1 Straight Handpiece, incorporate a temperature sensor to be used in the service of the device, by trained service personnel, to access excessive heat in the handpiece, indicative of mechanical failure. This feature is not accessible to the practitioner.

X65L / X65 / M65 General Cutting Straight is intended for the following application(s): Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations. FX65 / FX65m / EX-5B General Cutting Straight is intended for the following application(s): Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations. Using a prophy angle, prophylaxis treatment of the surface of teeth and dental restorations.

The General Cutting Straight is a prescription-only dental straight handpiece used by qualified dental healthcare professionals in general dentistry. The General Cutting Straight includes six models: X65L, X65, M65, FX65m, FX65, and EX-5B. The General Cutting Straight conforms to ISO 14457 and is driven by an ISO 3964-compliant electric or air motor. The General Cutting Straight achieves its intended use in conjunction with an ISO 1797-compliant rotary instrument or a prophy angle that conforms to either ANSI ADA Standard No. 85-2004 (R2009) or ISO 14457. The General Cutting Straight is composed mainly of stainless steel, titanium, or aluminum, depending on the model, and is reusable, requiring cleaning and steam sterilization. The accessories of the General Cutting Straight include the Bur Stopper, Bur Stopper Puller, and E-Type Spray Nozzle. The General Cutting Straight is lubricated with the PANA SPRAY Plus [K163486] using the E-Type Spray Nozzle.

FX15 / FX15m / FX25 / FX25m FX Contra is intended for the following application(s): Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations. FX57 / FX57m FX Contra is intended for the following application(s): Prophylaxis treatment of the surface of teeth and dental restorations.

The FX Contra includes six models: FX15, FX15m, FX25, FX25m, FX57, and FX57m. The FX Contra handpieces are reusable contra-angle handpieces, driven by an ISO 3964 compliant electronic micromotor or air motor, that are intended for use in a healthcare facility/hospital setting by a trained health care professional in the field of general dentistry. The FX Contra handpieces are designed for general applications to prepare dental cavities for restorations (FX15/FX15m/FX25/FX25m) and for prophylactic teeth cleaning (FX57/FX57m). The FX Contra handpieces feature ISO 3964 compliant handpiece coupling connecting them to a dental unit through either a micromotor or an air motor. By these means the handpieces receive the energy for the gear for dental treatment. The maximum drive speed is 40,000 min-1 for FX15, FX15m, FX25, and FX25m; and 20,000 min-1 for FX57 and FX57m. The maximum rotation speed is 10,000 min-1 for FX15 and FX15m; 40,000 min-1 for FX25 and FX25m; and 5,000 min-1 for FX57 and FX57m. The FX Contra handpieces are composed mainly of stainless steel and aluminum and can be sterilized in a steam sterilizer (autoclave).

The intended use of the Lotus Prophy Angle is for polishing and cleaning teeth.

Lotus Prophy Angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth. Lotus Prophy Angle is intended for single use only and is provided aseptic in sealed packaging to be prevent contamination.

Products intended for professional use only. Used in general dentistry for restoration procedures.

The Lares Research Smoothdrive 1:5 contra angle is a high-speed dental handpiece which is driven by an electrical motor. The device is designed to be connected to ISO 3964 compatible electric motors operating between 0 and 40,000 rpm. The device has a 1:5 speed increasing transmission (identified by the industry standard red ring) which translates to a working end speed of 0 to 200,000 rpm. The device has a push button chucking system is designed to allow convenient bur changing for ISO 1797 type 3 burs.

Dental Handpiece with models of CA160, and CA500L are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth. Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

Dental Handpiece with the model CA160, CA160L and CA500L consists of the main body of the handpiece, which is used for transmitting rotational force for the general dental treatments. The torque transmitted from a wired electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism. Model CA160, CA160L and CA500L can be connected to spray adapter (accessory component) which is used for channeling water and air for further applications to the dental treatments. The only difference between model CA160 and CA160L is that the CA160L has lighting function.

The SURGmatic S15 L Pro handpiece is intended for: - Oral, jaw and facial surgery - Tooth extraction procedures - Root resection - Osteotomy - Removal of carious material - Tooth, cavity and crown preparations - Processing of fillings The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and/or oral surgery.

The electrical-driven SURGmatic S15 L Pro handpieces in accordance with 21 CFR § 872.4200 (dental handpieces and accessories) designed for use by a trained professional in the field of general dentistry only. The device is an electrically driven handpiece that is reusable and provided with a fiber optic light system. The electrical motor includes the light source and the SURGmatic S15 L Pro handbiece is provided with a fiber optic light transmitter to transport the light to the bur side. DIN EN ISO 14457 requlates the minimum illuminance. The dental handpieces can be sterilized in a steam sterilizer (autoclave). SURGmatic handpieces equipped with a handpiece connector in accordance with ISO 3964 are connected to a treatment unit by means of a hose and the electrical motor and receive the energy for the gear, cooling water and air for conservative dental treatment as well as the light for illumination of the operation area through corresponding output openings. Burs in accordance with ISO 1797-1 must be used with the SURGmatic handpieces. Based on the INTRAmatic connection that meets the ISO 3964 standard, the SURGmatic handpieces fit with any electrical dental motor which is produced in accordance to this standard. The SURGmatic handpieces interact with the patient through a rotating bur with the patient teeth according to the intended use. The electrical motor rotates with an idle speed of 40.000 1/min and the gear ratio of the SURGmatic S15 L Pro instrument amounts to 1:5 (exactly 1:4,71). The bur is held in the rotating head drive with the help of a collet and can be released by a push-button mechanism. DIN EN ISO 14457 requlates the minimum extraction force of the bur.

The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials.

The subject modified General Cutting Contra Handpiece (modified Ti-Max Z Series: Z10L, Z15L, Z25L, Z85L, Z95L) is a contra-angle dental handpiece powered by either an air-motor or electronic-micromotor for use in general dentistry. The modified General Cutting Contra Handpiece is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials, and removal of crowns and filling materials. The modified General Cutting Contra Handpiece transmits rotational force from the motor to the gears through a clutch. The allowable maximum speed for the motor is 40,000 min-1. Then the rotation force reaches the chuck and the dental bur receives the rotation force. The dental bur cuts and grinds teeth using the rotation force. The rotation speed varies depending on the gear ratios as follows: Z95L 1:5 Increasing, Z85L 1:5 Increasing, Z25L 1:1 Direct Drive, Z15L 4:1 Reducing, Z10L 16:1 Reducing. The modified General Cutting Contra Handpiece feature fiber optic providing illumination to the cutting area. The subject of this Special 510(k) submission is an addition of the Switching Valve that allows to alternate between two types of water spray options: water spray (water + air) and water jet (water only) to the cleared device [K182999] to reduce the area of irrigation water splattering. This alternation is enabled using the Wrench accessory that has been previously cleared as a part of K121901. The coating material for the exterior of the handpiece has been changed from DURACOAT (Ti+MRK-T) to DURAGRIP (Ti+CrN). The coating material was previously used in the exterior of the nano Series of the predicate General Cutting Contra Handpiece [K182999] and has been cleared by FDA in 2019. The original submission [K182999] included four series of contra handpieces: the S-Max M Series, the Ti-Max X Series, the Ti-Max Z Series, and the Ti-Max nano Series. The proposed modification applies solely to the Ti-Max Z series. The following models will be affected by this change: Z10L, Z15L, Z25L, Z85L, Z95L. The modified models are marked with "SW" on the neck on the handpiece. The models that were cleared under the original General Cutting Contra Handpieces submission are not impacted by the present submission.

The TRAUS Dental Handpieces, TRAUS CRB46LN and TRAUS CRB46NN are intended for a wide range of dental procedures including: A. Implant placement , including - 1. Preparation of the osteotomy site - 2. Bone contouring , osteoplasty - B. Periodontal surgeries - 1. Bone contouring & alveoplasty around living teeth - 2. Removal of exostosis - C. Bone grafting - 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.) - 2. Harvesting autogen living bone - 3. Sinus elevation & grafting of alveolar sockets D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions

The TRAUS Dental Handpieces; TRAUS CRB46LN and TRAUS CRB46NN are gear driven hand-held dental handpieces with Gear Ratio of 20:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.