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510(k) Data Aggregation

    K Number
    K242432
    Device Name
    MT-Bone
    Manufacturer
    Mectron S.p.A.
    Date Cleared
    2024-08-19

    (3 days)

    Product Code
    DZI, ELC
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mectron S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MT-Bone is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: - Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures; - Scaling applications, including: Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits: · Periodontology: Periodontal therapy and debridement for all types of periodontal diseases. including periodontal pocket irrigation and cleaning; · Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation; · Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
    Device Description
    MT-Bone is a piezoelectric ultrasonic device designed for oral bone surgery. MT-Bone uses piezoelectric ultrasound technology to generate mechanical micro vibrations that can cut, drill or abrade through mineralized structures using appropriate inserts. This allows an efficient and safe action which preserves the integrity of the osteotomized surfaces. The micrometric, ultrasonic vibrations of the inserts provide greater precision and a selective action compared to traditional methods such as drills or oscillating saws (which act with macro vibrations), therefore minimizing traumatic effect on soft tissues. Depending by the Indication for use a lot of different type of inserts are available in Mectron portfolio.
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    K Number
    K231391
    Device Name
    Combi Touch
    Manufacturer
    Mectron S.p.A.
    Date Cleared
    2023-05-15

    (3 days)

    Product Code
    ELC, KOJ
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mectron S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    combi touch incorporates, within a single device, the functions of an ultrasonic scaler and of an air-polishing prophylaxis unit. Ultrasonic scaler function: combi touch, by using the appropriate associated inserts and the ultrasonic handpiece, is intended for use in the following dental applications: - Removing supra and subgingival calculus deposits and stains from teeth - Periodontal therapy and debridement for all types of periodontal disease, including periodontal pocket lavage with simultaneous ultrasonic tip movement - Scaling and root planing - Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha - Plugging for amalgam condensation - Amalgam burnishing - Preparing, cleaning and irrigating roots canals - Cavity preparation - Cleaning restorations and implant surfaces Air-polishing prophylaxis function: By using the appropriate air polishing handpiece, combi touch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment. The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. combi touch is intended for the following oral prophylaxis procedures: - Plaque removal for placement of sealants - Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers - Surface preparation prior to placing composite restorations - Effective plaque and stain removal for orthodontic patients - Cleaning prior to bonding ortho brackets - Cleaning implant fixtures prior to loading - Stain removal for shade determination - Plaque removal prior to fluoride treatment - Plaque and stain removal prior to whitening procedure combi touch is also intended for use as an air-polisher in patients suffering from periodontal disease. combi touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
    Device Description
    The combi touch combines, in a single appliance, a multi-purpose piezoelectric scaler and water jet, air, and powder polisher, intended for complete supra- and subgingival dental prophylaxis. In regards to the various possible ultrasonic treatments, combi touch can be used either connected directly to the main water supply in the dental practice, or with independent irrigation through the special liquid container, which can hold different types of medical solutions. The appliance is equipped with an automatic tuning circuit which compensates the wear of the inserts, thus always allowing operation in conditions of maximum efficiency. The operating principle of the polisher is based on the mechanical action obtained from a jet of various crystal types accelerated by a flow of compressed air. The kinetic energy thus imprinted at the particles, dissipates almost completely due to impact against the surface of the enamel, producing a gentle but effective cleaning action. The action is completed by a jet of water which, using the vacuum created around the air-polishing handpiece, has a bellshape around the main flow, thus producing a double effect: to prevent much of the rebound and the leakage of the cloud of powder and perform continuous washing of the treated area, dissolving the powder.
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    K Number
    K132848
    Device Name
    PIEZOSURGERY FLEX
    Manufacturer
    MECTRON S.P.A.
    Date Cleared
    2013-11-29

    (79 days)

    Product Code
    JDX, DZI, ERL, HBE, HWE
    Regulation Number
    888.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    MECTRON S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Piezosurgery FLEX is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and paalstic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.
    Device Description
    Piezosurgery FLEX is a piezoelectric ultrasonic device that uses ultrasonic energy to generate mechanical micro-vibration of tip inserts intended for bone cutting. The device consists of a base control unit with intearated peristaltic pump, a sterilizable handpiece with connecting cord, a range of sterile, single use tip inserts, a torque wrench, a foot-pedal, an irrigation set, and other minor attachments. The console is equipped with a touch panel that allows the surgeon to control device operation. The control panel also provides monitoring information, by means icons, in case of malfunction of the device. Inside the console are located the ultrasonic generator, the electrical power supply module and the micro-processor electronic board that controls and supervises the functional parameters of the device. The console is connected to mains power by an electrical cord, and includes connectors for the handpiece and for the foot-pedal. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are simultaneously activated by pressing the foot-pedal. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece. The touch panel of the console allows the operator to set the treatment parameters, as follows: - Seven levels of power: . - Six levels of irrigation: . - Three ultrasonic output modes; . - · The pump function. The Piezosurgery FLEX uses piezoelectric ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the tip insert.
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    K Number
    K122322
    Device Name
    PIEZOSURGERY TOUCH
    Manufacturer
    MECTRON S.P.A.
    Date Cleared
    2012-12-06

    (127 days)

    Product Code
    DZI, CLA, ELC
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    MECTRON S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: - · Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures; - · Scaling applications, including: - · Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits; - · Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning; - · Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation; - · Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
    Device Description
    Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts.
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    K Number
    K102218
    Device Name
    COMPACT PIEZO P2K, POWERCARE
    Manufacturer
    MECTRON S.P.A.
    Date Cleared
    2011-01-24

    (171 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    MECTRON S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Compact Piezo P2K and Powercare devices are ultrasonic scalers intended for use, with the appropriate associated insert tips, in the following dental applications: Scaling: All general procedures for removal of supragingival and interdental calculus/plaque deposits. Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning. Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation. Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
    Device Description
    The Compact Piezo P2K and Powercare are multipurpose piezoelectric ultrasonic scaler sub-assembly devices intended to be incorporated into a dental unit/table-top device and used for ultrasonic treatment in scaling. periodontics, endodontics and prosthetics dental applications. The Compact Piezo P2K and Powercare devices are intended to be supplied as modular sub-assemblies devices to OEM manufacturers of dental units. The subject devices consist of an ultrasonic generator, a handpiece with cord, a range of insert tips, a torque wrench and a wiring connections kit. The subject devices are intended to be assembled inside a dental unit and connected to the unit's electrical supply by the wiring connections kit provided. The handpiece cord is connected directly to the ultrasonic generator from which it receives the functional drive signals, including those for water supply from the dental unit for water irrigation. The ultrasonic power and water flow are simultaneously activated by pressing the footswitch of the dental unit. The power output and water flow are adjusted by the dental unit's controls. The Compact Piezo P2K and the Power Care devices use a piezoelectric transducer inside the handpiece to generate the insert tip oscillation. The ultrasonic transducer uses four piezoceramic disks to convert the generator's electrical signal to ultrasonic mechanical vibration of the insert tip. A key function of the ultrasonic generator is to locate the optimal frequency of the transducer/insert tip and then to drive the output at this resonant frequency.
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    K Number
    K092951
    Device Name
    STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS
    Manufacturer
    MECTRON S.P.A.
    Date Cleared
    2009-12-07

    (74 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    MECTRON S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Starlight Pro and Silverlight devices are dental curing light units intended for use in the oral cavity for the polymerization of photo-hardening dental materials that are activated in the 440 - 480 nm wavelength range.
    Device Description
    The Starlight Pro and Silverlight are dental curing light units intended for the polymerization of photo-hardening dental materials in the oral cavity. A light emitting diode (LED) with a wavelength between 440 nm is used in both devices as the light source. The spectrum of the light emitted by the LED corresponds to the absorption spectrum of camphorquinone photo-initiator, which is the most common and widely used visible light photo-initiator in among available photohardening dental materials. Camphorquinone photo-initiator has an light absorption curve ranging approx. from 400 - 500 nm, with a peak absorption at approx. 468 nm. This range falls within the emission spectrum of the LED used in the subject devices, making the units effective for the polymerization of camphorquinone-based dental materials. The subject devices consist of a cordless handpiece, powered by a rechargeable battery, and incorporating a LED as light source, a battery charger unit and a fiber optic that directs the light onto the material being polymerized. The devices allow the user to activate two curing modes ('Fast' and 'Slow Rise') by pressing the relevant push-button on the handpiece. These two curing modes differ in the light exposure and in the mode with which the light is emitted. In particular: The fast curing mode has an exposure time of 10 sec. at the maximum light intensity. The slow rise exposure mode has an exposure time of 20 sec. with a gradual increase of light during the first 3 seconds up to the maximum intensity. Acoustic signal timings are emitted by the handpiece during program execution. The charger unit allows recharging of the battery and it has an integrated light meter to check the light output. On the charger unit are three signaling LED lamps, indicating the on/off unit state, the battery charge state, and the functionality of the battery.
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