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510(k) Data Aggregation

    K Number
    K242317
    Device Name
    Integrated Endo System (Meet Endo-II)
    Manufacturer
    Denjoy Dental Co., Ltd.
    Date Cleared
    2025-02-13

    (192 days)

    Product Code
    ELC, EKR, EKX
    Regulation Number
    872.4850
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integrated Endo System is dental device which combine in a single main control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to assist the operator to locate the file tip in the root canal and an ultrasonic-handpiece for root-canal cleaning and preparation. The Integrated Endo System is intended solely for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.
    Device Description
    The Integrated Endo System Meet Endo-II is composed of Main Unit, Adapter, MeetMotor, MeetFill, MeetActivator. It is standalone AC-powered dental control units with a touch display screen to which multiple hand-held dental handpieces for root canal therapy procedure (MeetMotor is for root canal preparation, MeetFill is for root canal backfilling, MeetPex is for working length measurement of root canal, MeetActivator is for root canal irrigation). These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of the Integrated Endo System different handpieces can be combined with the control unit. The key hand-held components like handpieces or endodontic tools of the Integrated Endo System are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.
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    K Number
    K233844
    Device Name
    OdneClean
    Manufacturer
    Odne AG
    Date Cleared
    2024-08-08

    (248 days)

    Product Code
    ELC
    Regulation Number
    872.4850
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OdneClean is intended to prepare, clean, and irrigate teeth indicated for root canal therapy.
    Device Description
    OdneClean is a dental device for the preparation of root canals during endodontic procedures. It achieves this by the creation of hydraulic cavitation inside the root canal. It consists of a console (control unit), an irrigation fluid reservor (saline solution bag or bottle), and a handpiece that is equipped with single-use OdneClean tips. OdneClean delivers a stream of pressurized irrigation fluid (0.9 % NaCl) into the root canal. Upon leaving the narrow nozzle of the tip, it creates hydraulic cavitation inside the fluid stream, which enables the removal of organic matter from the root canal. OdneClean features a user interface on its console and an on/off button on the handpiece. It provides automatic priming and disinfection programs to prepare the device for use and disinfect the internal fluid path after use. A waste container collects the fluid generated during priming and disinfection. OdneClean is used after a conventional access cavity preparation, determination of the working length, and minimal shaping of the root canal. Following OdneClean treatment, root canals are to be disinfected using standard procedures.
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    K Number
    K240707
    Device Name
    Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)
    Manufacturer
    Shenzhen Micro Electric Intelligence Co., Ltd.
    Date Cleared
    2024-07-02

    (109 days)

    Product Code
    ELC
    Regulation Number
    872.4850
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultrasonic Scaler is used to remove dental plaque from teeth and remove stains on teeth during dental cleaning.
    Device Description
    A device intended for use during dental cleaning and periodontal (gum) therapy to remove adherent plaque and food debris from the teeth to reduce tooth decay, potential stains in the gingival groove, the back of the tooth and the tooth and associated gingival line. The electronic oscillation circuit generates ultrasonic frequency electric pulse wave, which is amplified to a certain intensity and conveyed to the transducer. The electrical energy is converted into mechanical energy, and the working head tool is stimulated to produce vibration of the same frequency, so as to achieve the purpose of crushing calculus and loosening tartar.
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    K Number
    K240801
    Device Name
    BioSonic US200 Ultrasonic Scaler (60034537)
    Manufacturer
    Dent4You AG
    Date Cleared
    2024-07-01

    (98 days)

    Product Code
    ELC
    Regulation Number
    872.4850
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultrasonic Applications for: - All sub-gingival and supra-gingival scaling and routine prophylaxis procedures. - Periodontal therapy
    Device Description
    The BioSonic US200 Ultrasonic Scaler is an ultrasonic scaling unit that is used in sub-gingival and supra-gingival scaling and routing prophylaxis procedures, and periodontal therapy. The BioSonic US200 Ultrasonic Scaler includes the main unit, handpiece, footswitch, removable sheath, and a selection of scaler inserts. This device generates high frequency waves that cause the tip of the scaler insert to vibrate at 25kHz or 30kHz depending on the scaler insert used.
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    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
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    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
    K223340
    Device Name
    EDS Calculus Softener TURBO CR
    Manufacturer
    Essential Dental Systems Inc.
    Date Cleared
    2023-12-11

    (405 days)

    Product Code
    ELC
    Regulation Number
    872.4850
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Softens dental calculus, tartar, and/or plaque to facilitate easier removal; Reduces scaling time; May be used in hand and ultrasonic scaling procedures.
    Device Description
    EDS Calculus Softener (TURBO-CR™) is a professional use only product to be used by a dental hygienist to aid in the cleaning and removal of dental plaque, mineralized calculus and/or tartar from subgingival root surfaces and supragingival areas of teeth. The composition helps remove the etiological factors which have been implicated in fostering periodontal disease. The device contains chelating agents and detergents which reduce the hardness of mineralized plaque, calculus, and/or tartar. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. The device contains an alkaline paste which effervescences or foams upon mixing through a mixing tip. This effervescence helps drive the activated composition into the "hard to reach" interproximal spaces between teeth as into the subgingival regions where tartar/plaque and or dental calculus can accumulate. It is packaged in the familiar double-barrel syringe configuration used by numerous other dental materials. The double barrel syringe is placed into a manual cartridge gun (commonly available at the dental clinic) and the composition is dispensed into a dental tray which is then placed over the patient's dental arch for cleaning. The steps required to properly express the calculus softening composition are: remove cap, attach mixer, place into manual cartridge gun, express the material into a dental tray, and then place into the patient's mouth over the dental arch to be cleaned/debrided for 60 seconds. The patient is then instructed to rinse and the dental scaling can commence by the dental hygienist. After use, the mixer/dispensing tip and dental tray should be discarded and the cap replaced. The device is provided non-sterile and does not contain fluoride or any whitening agents.
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    K Number
    K230641
    Device Name
    Ultrasonic Scaler Tips
    Manufacturer
    Guilin Refine Medical Instrument Co., Ltd.
    Date Cleared
    2023-11-21

    (258 days)

    Product Code
    ELC
    Regulation Number
    872.4850
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ultrasonic scaler tips are intended for use by dental professionals to: 1. Remove supra and sub gingival calculus deposits and stain from the teeth; 2. Clean and irrigate root canals.
    Device Description
    Ultrasonic scaler tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. The devices are used during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodontic applications to prepare the teeth and/or root of the teeth for repair. The models are GD1, GD2, GD4, GD5, GD6, PD1, PD3, PD4, PD4D, ED1. The Ultrasonic scaler tips are made from Stainless Steel 30Cr13 and the endo files are made of Nickel Titanium Alloy. The tips will be available in M3x0.6 internal thread. GD series and PD series(except for PD4D) are used to remove calculus deposits from teeth; PD4D and ED1 are used for root canal indication.
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    K Number
    K223173
    Device Name
    Proxeo ULTRA (PB-510, PB-520 and PB-530)
    Manufacturer
    W&H Dentalwerk Buermoss GmbH
    Date Cleared
    2023-07-14

    (276 days)

    Product Code
    ELC
    Regulation Number
    872.4850
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Drive unit with a piezoceramic oscillating system, which moves the tip in a linear oscillation. The drive unit is used for the removal of supragival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.
    Device Description
    The Proxeo ULTRA is a drive unit including handpieces with a piezoceramic oscillating system, which moves the tip in a linear oscillation. The drive unit is used for the removal of supragingival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel. The medical device consists of the following components that are also included in the scope of delivery: - Control unit (PB-510, PB-520, and PB-530) - Handpiece (PB-5 L, PB-5 L, S, and PB-5 L Q) - Foot control (wired, wireless) - A Power supply, instruction for use and other accessories The scaler tips are moved with a piezo-scaler handpiece by converting electrical energy into mechanical vibration. The coolant (water) is directed to the treatment site via a solenoid valve and a control unit via the tip. The scaler tips are re-usable [diamond-coated tips are single use only] and delivered non-sterile. Tips for use with Piezo Scaler for the following dental applications: - Scaling-tips - Periodontic-tips - Implant-cleaning-tips - Endodontic-tips - Tips for restoration and prosthetics With the foot control, corresponding device functions can be operated with the foot. These functions include, for example, program selection (button), operation of coolant function (button), motor direction of rotation selection (button), motor speed level (variable with pedal), power piezo handpiece (variable with pedal). Bluetooth Low Energy technology is used in the wireless foot controls (C-NW) to make this possible wirelessly as well. The foot controls are powered internally by a rechargeable battery (C-NW) or an external power source (C-NF).
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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
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    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
    K222096
    Device Name
    Endo Ultrasonic Activator
    Manufacturer
    Foshan COXO Medical Instrument Co.,Ltd.
    Date Cleared
    2023-03-23

    (248 days)

    Product Code
    ELC
    Regulation Number
    872.4850
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For root canal cleaning. The instrument must only be used in hospital environments, clinics or dental offices, by qualified practitioners.
    Device Description
    The Endo Ultrasonic Activator is mainly used for root canal cleaning.It mainly contain handpiece, sleeve, wrench, adapter and tip. The ultrasonic frequency generated by the CPU is driven by the drive circuit to drive the piezoelectric ceramic transducer, using the reverse piezoelectric effect to produce the ultrasonic vibration, motivating the working tip to produce the resonance, and using the cavitation and sound flow effect generated by the ultrasonic vibration to wash the root canal swing.
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