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The PERIO-FLOW nozzle, used with EMS PERIO-FLOW dental handpieces, is intended for patients suffering from periodontal disease. The PERIO-FLOW nozzle, used with EMS PERIO-FLOW dental handpieces, is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The PERIO-FLOW nozzle is a flexible, thermoplastic accessory to the PERIO-FLOW handpiece that is used with the EMS AIR-FLOW devices such as AIR-FLOW MASTER, AIR-FLOW MASTER PIEZON and AIR-FLOW handy PERIO and AIR-FLOW handy 3.0 Perio. The PERIO-FLOW nozzle includes printed markings and is molded from an alternate version of the cleared thermoplastic polyester elastomer. The marks are arranged to ensure that the user is aware of the location of the tip with respect to the pocket. There is a mark at 3 mm and 5 mm so that the user can evaluate the location of the tip during a procedure. The 5mm mark is bolder to indicate the depth limit. The line and the square located above the 5 mm line serve to ensure that the user does not insert the nozzle deeper than 5mm in the pocket. The PERIO-FLOW nozzle is provided non-sterile. The nozzle is single use only and is intended for use under clean conditions. The principle of operation of the proposed PERIO-FLOW nozzle is identical to predicate device nozzle (DT-113) which was cleared with the predicate system AIR-FLOW handy 3.0 PERIO (K132480 cleared on 02/24/2014). EMS dental handpieces connect to a standard turbine connection on a dental operative unit and deliver a mixture of water, air, and the prophylaxis powder to a treatment site. The air /powder mixture exits the distal end of the PERIO-FLOW handpiece through the PERIO-FLOW nozzle where it meets with a water spray in the pocket.

The AIR-FLOW PLUS Prophylaxis Powder is indicated for use with EMS dental handpieces for cleaning and preparation of teeth.

The proposed AIR-FLOW PLUS Prophylaxis Powder is an erythritol powder containing 0.05% Cetyl Pyridinium Chloride (CPC) as a preservative. This prophylaxis powder is intended to be used with all currently available EMS dental handpieces for AIR-FLOW and PERIO-FLOW treatments. The addition of CPC is to preserve the powder from bacterial contamination by humidity and microorganisms when the container is opened. Clinical studies have not been conducted to demonstrate that the presence of CPC in this device results in improved clinical outcomes. The principle of operation of the proposed AIR-FLOW PLUS Prophylaxis Powder is identical to predicate and reference device powder is mixed with air and water in the dental handpiece nozzle to create a mechanically abrasive stream used in polishing procedures.

The AIR-FLOW handy 3.0 PLUS Dental Handpiece is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and EMS prophylaxis powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances. The AIR-FLOW handy 3.0 PLUS is intended for patients suffering from periodontal disease. The AIR-FLOW handy 3.0 PLUS is indicated for the non-surgical removal of subgingival plaque in pockets up to 4 mm after initial periodontal treatment.

The proposed AIR-FLOW handy 3.0 PLUS device is similar in design and materials to the predicates AIR-FLOW handy 3.0 (K132478) and AIR-FLOW handy 3.0 PERIO (K132480). The proposed AIR-FLOW handy 3.0 PLUS device and the predicates connect to a standard turbine connection on a dental operative unit and deliver a mixture of water, air, and prophylaxis powder to a treatment site. The handpiece component of the proposed AIR-FLOW handy 3.0 PLUS (PLUS) is to be commercialized as an additional optional accessory to the predicate AIR-FLOW handy 3.0 PERIO (PERIO) handpiece component. Therefore, the proposed PLUS and the predicate PERIO share the same EMS reference number FT-221#. The purpose for adding this additional PLUS handpiece is so that the patients can have both supragingival treatments and subgingival treatments by the same AIR-FLOW PERIO prophylaxis powder that is previously cleared in AIR-FLOW MASTER (K082791) and thus create more convenience for the users. There are no changes to the powder in this submission. The AIR-FLOW handy 3.0 (STANDARD) and the proposed device, AIR-FLOW handy 3.0 PLUS (PLUS) handpieces, have the same air and water ports to enable supragingival use. The difference between the proposed PLUS and the predicate PERIO is the handpiece, which has the same body, powder chamber and handpiece body with the only difference being the nozzle. The geometric shape of the integrated nozzle of the PLUS handpiece is relatively thin and slim which enables the supragingival use and the subgingival use in pockets up to 4 mm after initial periodontal treatment. The integrated nozzle of PLUS handpiece has no direct contact with the subgingival shallow pocket. The separate slim nozzle of PERIO that has direct contract with the subgingival pocket enables the subgingival use in pockets up to 5mm after initial periodontal treatment. The PLUS handpiece should not be used with the STANDARD powder chamber. To prevent this, a different connector is used so that it can only be used with the PERIO powder and PERIO powder chamber. The PLUS handpiece uses the same PERIO polishing powder as the PERIO handpiece. The proposed AIR-FLOW handy 3.0 PLUS device is therefore substantially equivalent to the previously FDA-cleared AIR-FLOW handy 3.0 PERIO (K132480) and AIR-FLOW handy 3.0 (K132478).

The PIEZON® 707 BIK and PIEZON® BIK LED is intended for use for the following indications: Scaling - Removal of supragingival calculus - Removal of stains Endo - Preparation, cleaning and irrigation of root canals - Condensing gutta-percha - Removal of crowns, bridges and restorations Restorative - Preparation of cavities - Cementation of restorations - Condensing of amalgams Periodontics - Scaling and root planing - Periodontal therapy

The PIEZON® 707 BIK and PIEZON® BIK LED is an ultrasonic scaling unit consisting of an ultrasonic generator supplied with a Piezon Handpiece and scaling instruments. The PIEZON® 707 BIK and PIEZON® BIK LED are supplied with the Piezon Handpiece EN-061 and Piezon Handpiece LED EN-060, respectively. The PIEZON® 707 BIK and PIEZON® BIK LED ultrasonic generator is designed for installation into a dental chair. The ultrasonic generator produces piezo-electric vibrations (ultrasonics) for water or dry work instruments. The appropriate instrument for a particular application is screwed onto the handpiece supplied with the scaling unit prior to beginning the procedure. The power control is handled via the potentiometer or the chair main control. The water control is handled via the handpiece or the chair main control. The treatment is carried out by placing the instrument tip onto the tooth surface according to the Operating Instruction for the instrument selected.

The AIR-FLOW handy 3.0 Dental Handpiece is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and EMS prophylaxis powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.

The proposed AIR-FLOW handy 3.0 is a modification of the AIR-FLOW handy 2 Dental Handpiece previously cleared under K022119. This device modification has been submitted as a Special 510(k) Premarket Notification because the indications for use for the proposed AIR-FLOW handy 3.0 are identical to the parent AIR-FLOW handy 2. The fundamental technology and design of the proposed AIR-FLOW handy 3.0 are essentially identical to the AIR-FLOW handy 2 dental handpiece. Both the proposed AIR-FLOW handy 3.0 and the predicate AIR-FLOW handy 2 connect to a standard turbine connection on a dental operative unit and deliver a mixture of water, air, and dental powder to a treatment site. Modifications made to the AIR-FLOW handy 2 Dental Handpiece to produce the AIR-FLOW handy 3.0 were limited to minor design changes to enhance the ergonomics of the design, including: - Location of the powder chamber is modified to improve the visibility of the mouth of patient by the practitioner during the treatment. - Slimmer shape of the powder chamber to be in-line with the body of the device to improve the visibility of the mouth of patient by the practitioner during the treatment. - Diameter of the powder chamber cap is reduced to be in-line with new design of the powder chamber. - The powder chamber capacity has been slightly decreased to 21g from 23g to fit new ergonomic design. - The body of the handy 3.0 is made of 2 glued molded part instead of 1 molded part. - The handpiece is shorter and slimmer to improve ergonomics. Accessories were included to aid in filling the powder chamber and removing residual powder from the handpiece channels. In addition, the AIR-FLOW CLASSIC COMFORT prophylaxis powder has been added to the panel of available prophylaxis powders. The chemical composition of the AIR-FLOW CLASSIC COMFORT Powder is identical to the AIR-FLOW CLASSIC that was described in the 510(k) Premarket Notification for the AIR-FLOW MASTER (K073284). The grain size was slightly reduced from a median particle size of < 65um for the AIR-FLOW CLASSIC to <40 um for the AIR-FLOW CLASSIC COMFORT prophylaxis powder to improve patient comfort during the prophylaxis treatment.

The AIR-FLOW handy 3.0 PERIO is intended for patients suffering from periodontal disease. The AIR-FLOW handy 3.0 PERIO is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The proposed AIR-FLOW handy 3.0 PERIO is a modification of the AIR-FLOW handy PERIO Dental Handpiece previously cleared under K092289. This device modification has been submitted as a Special 510(k) Premarket Notification because the indications for use for the proposed AIR-FLOW handy 3.0 PERIO are identical to the parent AIR-FLOW handy PERIO. The fundamental technology and design of the proposed AIR-FLOW handy 3.0 PERIO are essentially identical to the AIR-FLOW handy PERIO dental handpiece. Both the proposed AIR-FLOW handy 3.0 PERIO and the predicate AIR-FLOW handy PERIO connect to a standard turbine connection on a dental operative unit and deliver a mixture of water, air, and dental powder to a treatment site. Modifications made to the AIR-FLOW handy PERIO Dental Handpiece to produce the AIR-FLOW handy 3.0 PERIO were limited to minor design changes to enhance the ergonomics of the design, including: - Location of the powder chamber is modified to improve the visibility of the mouth of the patient by the practitioner during the treatment - Slimmer shape of the powder chamber to be in-line with the body of the device to improve the visibility of the mouth of the patient by the practitioner during the treatment. - Diameter of the powder chamber cap is reduced to be in-line with new design of the powder chamber. - The powder chamber capacity has been slightly decreased to 21g from 23g to fit new ergonomic design. - The body of the AIR-FLOW handy 3.0 PERIO is made of 2 glued molded parts instead of 1 molded part - The handpiece is shorter and slimmer to improve ergonomics. Accessories were included to aid in filling the powder chamber and removing residual powder from the handpiece channels.

The PIEZON 250 is a device for delivering ultrasonic movement and irrigant to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are: - Periodontal pocket lavage with simultaneous ultrasonic tip movement - Scaling and root planing - Removal of supra and subgingival calculus and stains from teeth

The proposed PIEZON 250 ultrasonic scaler is a modification of the previously cleared miniPiezon (K953026). The working instrument for the scaling function is the handpiece, which is connected to the control unit via a handpiece cord and mounted in a holder on the side of the control unit. In the proposed PIEZON 250, irrigating liguid is pumped to the handpiece from a 350ml (or 500ml) irrigating bottle by a peristaltic pump rather than from an external water supply. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit. The PIEZON 250 is supplied with two handpieces - the Piezon handpiece LED (lightemitting diode) and the Piezon handpiece. The Piezon handpiece LED is identical to the Piezon handpiece LED described in K093000 for the Piezon Master 700 ultrasonic scaler (K093000) and contains 6 LEDs in the body of the handpiece and a light guide that is positioned under the nozzle. The Piezon handpiece is identical to the Piezon handpiece LED, except that the Piezon handpiece does not have LEDs or the light guide. All instruments compatible with the PIEZON 250 have been previously cleared (see 510(k) numbers referenced in Section 3).

The PIEZON 150 is a device for delivering ultrasonic movement and water to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are: • Periodontal pocket lavage with simultaneous ultrasonic tip movement • Scaling and root planning • Removal of supra and subgingival calculus and stains from teeth • Intended for use in dental and periodontal applications performed by an ultrasonic scaler.

The proposed PIEZON 150 ultrasonic scaler is a modification of the previously cleared miniPiezon (K953026). The working instrument for the scaling function is the handpiece, which is connected to the control unit via a handpiece cord and mounted in a holder on the side of the control unit. The PIEZON 150 connects to an external water supply and delivers water via the connected handpiece. The power of ultrasonic vibrations is adjusted via a power knob on the top of the control unit. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit. The PIEZON 150 is supplied with two handpieces - the Piezon Handpiece LED (lightemitting diode) or the Piezon Handpiece. The Piezon Handpiece LED is identical to the Piezon Handpiece LED described in K093000 for the Piezon Master 700 ultrasonic scaler (K093000) and contains 6 LEDs in the body of the handpiece and a light guide that is positioned under the nozzle. The Piezon Handpiece is identical to the Piezon Handpiece LED, except that the Piezon Handpiece does not have LEDs or the light guide. All instruments compatible with the PIEZON 150 have been previously cleared (see 510(k) numbers referenced in Section 3). The modifications made to the miniPiezon to produce the PIEZON 150 include: • Shape and contours of the control unit redesigned to accommodate the finger-tip power control, improve aesthetics, facilitate cleaning, and enhance ergonomics • Use of a potentiometer for power regulation via the power control knob to improve ultrasonic power control. • One operating mode with a Standard power range (0-100% power) for scaling procedures and a Perio range (0-37.5% power) for periodontal procedures • Supported handpieces (Piezon Handpiece (FT-215#) and Piezon Handpiece LED (FT-223#) • Ultrasonic generator upgraded to EJ-110. the Light command, Motor/Solenoid valve command and Pedal command have been added.

The EMS AIR-FLOW MASTER is intended for patients suffering from periodontal disease and peri-implantitis. The EMS AIR-FI.OW MASTER is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The EMS AIR-FLOW MASTER is a dental air-polishing unit containing an operating unit, air pressure powered handpiece cords, powder chambers, an AIR-FLOW MASTER AIR-FLOW handpiece and a PERIO-FLOW handpiece, AIR-FLOW CLASSIC, SOFT and PERIO Prophylaxis powder, multifunction footpedal and connections for external water and air supply. The EMS AIR-FLOW MASTER is a modification of the EMS AIR-FLOW MASTER STANDARD that was cleared for marketing as K073284 for cleaning of teeth using a specially designed nozzle to deliver a mixture of water, air, and dental powders to a treatment site. The proposed EMS AIR-FLOW MASTER is supplied with a flexible thermoplastic nozzle that is used for subgingival cleaning of periodontal pockets.

The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument for use in surgical dentistry.

The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument designed for use in surgical dentistry. The device generates piezo-electric vibrations (ultrasonic energy) for cutting and non-cutting instruments used in surgical dentistry, including oral surgery, implantology, periodontal surgery, and maxillary surgery. The EMS Piezon Master Surgery device consists of a main chassis containing an irrigation delivery system, an internal electric power supply, a control panel with lightemitting diode (LED) displays, and ultrasonic generator. A one-step footswitch is connected to the main chassis by a footswitch cord and a handpiece containing cutting and non-cutting instruments is connected directly to the main chassis.