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510(k) Data Aggregation

    K Number
    K233922
    Device Name
    SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG
    Manufacturer
    SATELEC-ACTEON GROUP
    Date Cleared
    2024-03-11

    (89 days)

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

    SATELEC-ACTEON GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Scaling: - Interdental junction treatment - Tooth neck and subgingival treatment - Treatment of large deposits - Treatment of coating and tobacco stains - Interproximal treatment - Prosthesis conservative/restorative: - Inlay/onlay condensation - Amalgam plugging - Loosening prostheses (bridge, crown, post, pivot ... ) Endodontics: - Canal preparation - Canal cleaning - Canal filling - Gutta percha condensation - Treatment resumption - Retro surgery - Micro retro surgery - Surface smoothing after burring Periodontics: - Root planning - Initial therapy - Treatment of periodontal pockets - Treatment of furcations - Maintenance therapy
    Device Description
    The NEWTRON CAN A Module is an Ultrasonic Control Module intended to be integrated in a Dental Delivery System. The NEWTRON CAN A Module contains an Embedded Software. The NEWTRON CAN A Module is an Ultrasonic Control Module intended to be integrated in a Dental Delivery System manufactured by the American Company named A-DEC. The A-DEC Dental Delivery System provides different function to the NEWTRON CAN A Module such as Ultrasonic Power Setting, Light Command through a communication frame. The communication frame is designed and imposed by A-DEC, the Manufacturer of the Dental Delivery System. The values of Ultrasonic Power Setting and the Light Command are coded and communication frame. Ultrasonic Power Setting and the Light Command are driven by the user with a touch pad embedded in the A-DEC Dental Delivery System. The only parameters of the NEWTRON CAN A Module that can be modified by the A-DEC Dental Delivery System are the values of Ultrasonic Power Setting and the Light Command. The NEWTRON CAN A Module converts a low voltage Power Supply provided by the A-DEC Dental Delivery System into an Ultrasonic Electric Signal. The NEWTRON CAN A Module is intended to be used in combination with a SATELEC Dental Ultrasonic Handpiece and a SATELEC range of Dental Tips. The electrical signal emitted by the NEWTRON CAN A Module supplies the Dental Ultrasonic Handpiece equipped with SATELEC Dental Tip. The amplitude of the ultrasonic micro-vibrations depends on the electrical Signal provided by the NEWTRON CAN A Module (amplitude). The SATELEC Dental Ultrasonic Handpiece is connected to the Dental Delivery System via a Handpiece cord. Mechanical micro- vibrations are transmitted to a Dental tip attached to the end of the SATELEC Dental Ultrasonic Handpiece.
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    K Number
    K172137
    Device Name
    PIEZOTOME CUBE
    Manufacturer
    Satelec - Acteon Group
    Date Cleared
    2018-05-03

    (290 days)

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

    Satelec - Acteon Group

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PIEZOTOME CUBE is an ultrasonic surgical system that supply utilities to and serve as a base for dental tips. The PIEZOTOME CUBE consist of a control unit and handpiece intended for use in intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology.
    Device Description
    SATELEC CUBE is an piezoelectric device that uses micro-vibrations of associated Tips, to perform the dental procedures defined in Indication for Use. PIEZOTOME CUBE consists of a Console, a Multifunction footswitch and a reusable Handpiece. The Console is the heart of the SATELEC PIEZOTOME CUBE. The Console contains the display board and the motherboard. Ultrasonic Handpiece and Footswitch are connected to the Console. The Touch screen present on the front panel is used to define the settings of the SATELEC PIEZOTOME CUBE (Ultrasonic modes, irrigation flow values). The Ultrasonic Handpiece is held in the Practitioner's hand. The Ultrasonic Handpiece is connected to the Console via a Handpiece Cord. The Handpiece is dedicated to Dental Bone Surgery procedures. The Ultrasonic Handpiece is equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical micro-vibrations. The Ultrasonic Handpiece is reusable and Sterilizable by autoclaving. Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpiece. Tip are in direct contact to the patient. The ultrasonic mechanical vibrations are transmitted to the Tip. The Pump housing is designed to accommodate SATELEC Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation is intended to cool the clinical site and rinse the fragments such as bone or teeth.
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    K Number
    K131906
    Device Name
    SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE
    Manufacturer
    SATELEC-ACTEON GROUP
    Date Cleared
    2014-04-11

    (289 days)

    Product Code
    EBZ, 804
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    SATELEC-ACTEON GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SCANWAVE PEN is a source of illumination for the polymerization of light-curing dental materials curing in the wavelength range of 390 nm - 505 nm.
    Device Description
    SCANWAVE PEN is a Dental Curing Light. More precisely, SCANWAVE PEN is a source of illumination used for the polymerization of light-curing dental materials curing in the wavelength range of 390 nm - 505 nm. SCANWAVE PEN is equipped with a LED (Light Emitting Diode) which permit to polymerize a large range of dental materials present on the market. SCANWAVE PEN is an Electro-medical Device. SCANWAVE PEN is compatible with only ADEC Dental units. The Handpiece contains the electronic command board, the power board and the light source. The rigid protection shield to the Handpiece reduces the light propagation outside the initial site. This accessory is used to protect the eyes of the patient and the user during the Curing Light polymerization act. The O.E.M. Module is a power supply module intended to deliver the electrical source needed for the Handpiece functioning. The O.E.M. Module is integrated in an ADEC Dental Unit. The User Manual contains all needed information for a correct using (description, safety aspects, problems, cleaning, disinfecting and sterilization procedures).
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    K Number
    K132322
    Device Name
    NEWTRON P5 XS B.LED
    Manufacturer
    SATELEC-ACTEON GROUP
    Date Cleared
    2014-03-11

    (229 days)

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

    SATELEC-ACTEON GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosiblesis.
    Device Description
    The Satelec New Device is a Dental Ultrasonic Generator. The Satelec New Device uses Piezoelectric Technology. The Satelec New Device uses a Satelec Dental Piezoelectric Handpiece (NEWTRON SLIM B.LED). The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with Predicate Devices (K050895, cleared April 20, 2005 and K113430, cleared February 23, 2012).
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    K Number
    K132267
    Device Name
    NEWTRON P5, NEWTRON P5 B.LED
    Manufacturer
    SATELEC-ACTEON GROUP
    Date Cleared
    2014-03-10

    (231 days)

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

    SATELEC-ACTEON GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosthesis.
    Device Description
    The Satelec New Device is a Dental Ultrasonic Generator. The Satelec New Device uses Piezoelectric Technology. The Satelec New Device uses a Satelec Dental Piezoelectric Handpiece (NEWTRON SLIM or NEWTRON SLIM B.LED). The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with Predicate Devices (K050895, cleared April 20, 2005 and K113430, cleared February 23, 2012).
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    K Number
    K131151
    Device Name
    ENDOCENTER
    Manufacturer
    SATELEC-ACTEON GROUP
    Date Cleared
    2014-01-16

    (268 days)

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

    SATELEC-ACTEON GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use by dentists in standard endodontic procedures using rotary endodontic files or reciprocating endodontic files or use by dentists in periodontics, endodontics, scaling, prosthesis procedures with ultrasonic tips.
    Device Description
    The ENDO CENTER is an electric motor-driven handpiece combined with an ultrasonic scaler intended for root canal preparation procedures in endodontic industry. In ULTRASONIC mode, the device is able to drive piezo-electric resonator for root canal treatment at selectable power and fixed frequency . In ROTATING mode, the device is able to drive electrical micromotor for rotary files for root canal treatment at selectable speed and torque. In RECIPROCATING, mode, the device is able to drive electrical micromotor for reciprocating files for root canal treatment at selectable speed and rotational angle. The New Device is a combination of two existing devices already in consolidated use in endodontic field.
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    K Number
    K131997
    Device Name
    NEWTRON BOOSTER
    Manufacturer
    SATELEC-ACTEON GROUP
    Date Cleared
    2013-11-26

    (151 days)

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

    SATELEC-ACTEON GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The medical device is used in association with a dental ultrasound handpiece to which an ultrasound instrument is attached. It is designed for the treatment of scaling (prophylaxis), periodontics, endodontics and prosthesis (preservation and restoration dentistry).
    Device Description
    The Satelec New Device is a Dental Ultrasonic Generator. The Sateler New Device uses Piezoelectric Technology.The Satelec New Device uses a Satelec Dental Piezoelectric Plezonecht - Technology. The Satelec New Device can use the same Handpiece Harroplece (NEWTRON OElin). In Option the School (K050895, cleared April 20, 2005). The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with The Satelec New Device is Gesigned to be association of the St. 430, cleared February 23, 2012) or other new Satelec Dental Tips.
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    K Number
    K113430
    Device Name
    PROULTRA PIEZO ULTRASONIC
    Manufacturer
    SATELEC-ACTEON GROUP
    Date Cleared
    2012-02-23

    (94 days)

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

    SATELEC-ACTEON GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator intended for use with The Frookia , lead on for, scaling, periodontics, prosthesis and endodontic Dental Applications.
    Device Description
    ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator.
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    K Number
    K112188
    Device Name
    PIEZOTOME SOLO
    Manufacturer
    SATELEC - ACTEON, INC.
    Date Cleared
    2012-02-03

    (189 days)

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

    SATELEC - ACTEON, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Satelec PIEZOTOME SOLO (or PIEZOTOME SOLO LED available in option) is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.
    Device Description
    The New Device is a dental operative unit that supplies utilities to and serves as a base for Satelec Bone Cutting Handpiece (K091252, cleared July 22, 2009). The New Device uses Piezoelectric Ultrasound Technology to generate mechanical micro vibrations for bone cutting, with minimal trauma to soft tissue. The device is supplied with Dental Bone Surgery Tips for use in dental surgery, including osteotomy, osteoplasty and implantology. Also, the New Device uses accessories such as Piezoelectric Handpiece, Multifunction Footswitch, Bracket and Irrigation Tubing.
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    K Number
    K111623
    Device Name
    I-ENDO DUAL
    Manufacturer
    SATELEC-ACTEON GROUP
    Date Cleared
    2012-01-10

    (214 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SATELEC-ACTEON GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    I-Endo Dual is indicated for use by dentists in standard endodontic procedures using endodontic files and endodontic drills.
    Device Description
    The I ENDO DUAL is an electric motor-driven handpiece intended for root canal preparation procedures in the endodontic industry. It works in both reciprocating mode and continuous rotation. The motor allows the dentist to program 10 settings of their choice for speed and torque control in rotating mode and to program 10 setting of their choice for speed and angles in reciprocating mode. The device consists of a control unit with an LCD screen for selection of settings. A foot pedal is connected to the control unit so the dentist can selectively activate and deactivate the motor.
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