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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
    K222583
    Device Name
    Stela Capsule System
    Manufacturer
    SDI Limited
    Date Cleared
    2022-10-28

    (63 days)

    Product Code
    EBF, KLE, REG
    Regulation Number
    872.3690
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stela Primer: - Dentin and enamel bonding Stela Capsule - Direct Class I, II, III and V cavities. Ideally Class I and II - Base or liner - Core build-ups.
    Device Description
    The Stela Capsule System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises: - Stela Capsule - a capsule consisting of powder and liquid components which are mixed and activated when the capsule is pushed down. After mixing with a triturator (amalgamator) an applicator is used to dispense the paste. - Stela Primer an adhesive liquid packaged in a bottle. A bendable disposable brush applicator is used to apply Stela Primer. The combination of Stela Primer and Stela Capsule will bond to both enamel and dentin without scrubbing or light curing.
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    K Number
    K211721
    Device Name
    PS System
    Manufacturer
    Inter-Med, INC.
    Date Cleared
    2021-12-02

    (181 days)

    Product Code
    NYL
    Regulation Number
    872.4200
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
    Device Description
    The PS System presents a clinically effective way to irrigate the entire canal space during root canal treatments. The PS System is a closed system negative pressure irrigation apparatus that draws fluid through the individually placed cannula toward the coronal chamber by way of evacuation that is controlled independently through the dental chair vacuum system, eliminating the risk of apical irrigant extrusion during root canal procedures. The PS System creates a closed system by establishing an air tight seal between the tooth and stage via a lightcurable barrier. The PS System is designed to accommodate the full range of tooth and root canal anatomy and is offered in three specific procedural kits based on the type of tooth to be treated: anterior, premolar, and molar.
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    K Number
    K202906
    Device Name
    EndoPilot2
    Manufacturer
    Schlumbohm GmbH & Co. KG
    Date Cleared
    2021-04-13

    (196 days)

    Product Code
    ELC, EKR, EKX, LQY
    Regulation Number
    872.4850
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoPilot2 systems are dental devices which combine in a single control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to locate the file tip in the rot canal and an ultrasonic-handpiece for root-canal cleaning and preparation. The EndoPilot is intended solely for use by trained dental professional health care facilities on patients that need root-canal-treatment.
    Device Description
    The EndoPilot2 systems, including the models "comfort", "plus", "ultra plus" and the model variant under brand "CanalPro Jeni" (marketed by Distributor Coltène/Whaledent Inc. and identical for technical aspects to model EndoPilot² comfort) are standalone AC-powered dental control units with a touch display to which multiple hand-held dental handpieces for root canal preparation (Apex measurement, EndoMotor, Ultrasonic handpiece) and/or root-canal filling (DownPack, BackFill handpiece) can be connected. These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of these EndoPilot2 systems different handpieces can be combined with the control unit and different device variants (systems) of the EndoPilot²exist. The key hand-held components like handpieces or endodontic tools of the EndoPilot² 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
    K193409
    Device Name
    Vista Rinse, Vista Rinse Plus
    Manufacturer
    Inter-Med/Vista Dental Products
    Date Cleared
    2020-09-09

    (275 days)

    Product Code
    KJJ
    Regulation Number
    N/A
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation.
    Device Description
    Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation. Both medical devices are packaged in bottles. Clinical use of the medical devices requires the irrigant to be expelled from syringes through irrigation tips, which are class I medical devices per EIC product code (syringe, periodontic, endodontic, irrigating) and CFR regulation number 872.4565 and are 510(k) exempt.
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    K Number
    K190998
    Device Name
    BA Pit & Fissure Sealant
    Manufacturer
    Apex Dental Materials, Inc.
    Date Cleared
    2019-11-08

    (206 days)

    Product Code
    EBC
    Regulation Number
    872.3765
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BA Pit & Fissure Sealant is intended to seal pit and fissure depressions/faults in the biting surfaces of teeth. For dental professional use only.
    Device Description
    Pit and Fissure sealants are used as a preventive measure to fill defects and prevent decay within crevices, voids or fissures on the surface of teeth. These voids are more challenging to keep free of substances that can lead to caries and eventual breakdown of tooth structure. BA Pit & Fissure Sealant is a material designed to fill these voids with a wear resistant material, ultimately preserving natural tooth structure. BA Pit & Fissure Sealant is a light activated / photopolymerizable, glass filled, urethane dimethacrylate material that is placed onto an etched enamel surface and light activated for 20 seconds. The result after application is a tooth that has been sealed with a tough, wear resistant material.
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    K Number
    K182118
    Device Name
    armor LC
    Manufacturer
    Mavrik Dental Systems Ltd
    Date Cleared
    2019-05-03

    (270 days)

    Product Code
    EIE
    Regulation Number
    872.6300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    armor LC™ is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.
    Device Description
    armor LC™ is a light-cured resin dam designed to seal around and protect the gingival tissue during professional dental procedures. It consists of a viscous urethane dimethacrylate (UDMA)based resin foam supplied in a black 1 mL syringe. armor LC™ is only for prescription use and is a single-use, non-sterile, product. Using an applicator tip, the uncured product is applied over the gingival margin where it flows to form a seal at the base of the teeth. It is then rapidly light cured in situ to form a flexible material barrier. After the dental procedure it is readily removable with simple dental instruments.
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    K Number
    K171872
    Device Name
    P50 Series Dental Operative Unit and Accessories
    Manufacturer
    Pelton & Crane
    Date Cleared
    2018-04-26

    (307 days)

    Product Code
    EIA, EBW
    Regulation Number
    872.6640
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pelton & Crane P50 series Dental Operative Units and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The Pelton & Crane P50 series Dental Operative Units and Accessories are designed for use by a trained professional in the field of dentistry.
    Device Description
    The P50 series Dental Operative Unit and Accessories serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, patient dental chair, foot control, and a junction box that houses a power supply and air/water regulators. The unit may also include a dental operating light and a monitor. Various handpieces, instruments, and accessories can be added to the P50 series Dental Operative Unit which Pelton & Crane does not manufacture but does provide a means to connect them to the P50 series Dental Operative Units. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes, SE and HVE vacuum instruments. Water quality is maintained automatically by the preprogramed cleaning functions for the water lines, cuspidor spouts, and instrument hoses including motors and syringes. Instructions are provided for waterline treatment and suction cleaning agents. Water supply is available by either the municipal water supply or a self-contained water bottle.
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    K Number
    K171729
    Device Name
    Fixtemp C&B
    Manufacturer
    Dreve Dentamid GmbH
    Date Cleared
    2017-12-13

    (184 days)

    Product Code
    EBG
    Regulation Number
    872.3770
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fixtemp® C&B is a resin based material used to fabricate temporary crowns and bridges.
    Device Description
    Fixtemp® C&B is a two-component automatically mixable composite on the basis of multifunctional (meth)acrylates provided in standard double cartridges. The material is dispensed and mixed by cartridge/mixing tip combination and it is used for the manufacturing of temporary crowns and bridges for use until the permanent restoration is fabricated. It can be also used for inlays, onlays and veneers and is available in tooth-colors A1, A2, A3, A3.5, B1, Bleach X and D2. This is a prescription only material. The labeling and working instructions are designed for health care professionals.
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    K Number
    K161488
    Device Name
    ESTETICA Dental Treatment Unit and Accessories
    Manufacturer
    KALTENBACH & VOIGT GMBH
    Date Cleared
    2016-12-08

    (190 days)

    Product Code
    EIA
    Regulation Number
    872.6640
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESTETICA Dental Treatment Unit and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The ESTETICA Dental Treatment Unit and Accessories are designed for use by a trained professional in the field of general dentistry.
    Device Description
    The ESTETICA Dental Treatment Unit and Accessories serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The device includes a patient chair, foot control, dentist element, assistant element and a water unit. The unit may also include a dental operating light and a monitor. Various handpieces and accessories can be added to the ESTETICA Dental Treatment Unit and Accessories. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes and SE and HVE vacuum instruments.
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