Search Filters

Search Results

Found 42 results

510(k) Data Aggregation

    K Number
    K160099
    Device Name
    CEREC SpeedGlaze
    Manufacturer
    Sirona Dental Systems GmbH
    Date Cleared
    2016-06-02

    (135 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sirona Dental Systems GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Glazing of individually designed dental restorations from dental ceramics. The CEREC SpeedGlaze Spray is used for coating dental restorations made from Sirona CAD/CAM materials. It is administered extra-orally and is indicated for crowns, inlays, onlays, partial crowns and bridges in the anterior and posterior tooth region.
    Device Description
    The CEREC SpeedGlaze Spray is used to glaze dental restorations made from the Sirona CAD/CAM materials CEREC Zirconia, inCoris TZI C, CEREC Blocs C, CEREC Blocs C PC and CEREC Blocs C In. The spray meets the requirements of the ISO 6872:2008 "Dentistry - Ceramic materials". The product consists of a coated aluminum can cap, filled with a glaze and a valve and a spray nozzle, for applying the glaze. The CEREC Speed Glaze Spray is suitable for the coating of dental restorations from the Sirona CAD/CAM materials: CEREC Zirconia, inCoris TZI C, CEREC Blocs C, CEREC Blocs C PC and CEREC Blocs C In. The CEREC SpeedGlaze spray has to be administered extraorally. It is indicated for the following parts of dentistry: - crowns, inlays, onlays, partial crowns and bridges in the anterior and posterior tooth region. The product has 8 components as shown below: 1. Can: Aluminum monobloc spray can 2. Valve: For releasing the contents when engaged 3. Can cap PP - Polypropylene, Plastic 4. Spray nozzle: For spraying onto restoration 5. 14mm Glass balls For mixing of the components before spraying 6. Glaze Ceramic Silicate glass 7. Instruction for use Instructions for use document 8. Folding carton Package
    Ask a Question
    K Number
    K151045
    Device Name
    TENEO Dental Treatment Unit and Accessories
    Manufacturer
    SIRONA DENTAL SYSTEMS GMBH
    Date Cleared
    2015-07-24

    (95 days)

    Product Code
    EIA, EBW
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIRONA DENTAL SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dental treatment unit with accessories is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants. The motors serve as drives for rotating and oscillating straight and contra-angle hand pieces in connection with a dental treatment unit. They are used for endodontic and general dental purposes. The SPRAYVIT M multifunctional syringe is used for dental treatment with unheated air and heated water. It is also used to illuminate the preparation field.
    Device Description
    The TENEO dental treatment unit is a dental operating system. 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.
    Ask a Question
    K Number
    K150909
    Device Name
    INTEGO Family and Accesories
    Manufacturer
    Sirona Dental Systems GMBH
    Date Cleared
    2015-07-17

    (105 days)

    Product Code
    EIA, EBW
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sirona Dental Systems GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INTEGO Family of Dental Treatment Units with accessories is intended to supply power to and serve as a base for dental devices and accessories. Each unit includes a dental chair. The units are intended for use in the dental clinic environment and are used by trained dentists and/or dental assistants. The MOTOR BL ISO E is used to drive rotating and oscillating straight and contra-angle handpieces in connection with the dental treatment units for endodontic and general dental purposes. The SPRAYVIT E multifunctional syringe is used for dental treatment with unheated air and unheated water. The SPRAYVIT E multifunctional syringe is also used to illuminate the preparation field.
    Device Description
    The INTEGO family dental treatment unit is a dental operating system. INTEGO and INTEGO pro dental treatment units constitute the INTEGO Family. These are the successors of C8+. Components and functional principles are taken over or widely derived from this C8+. The units include a patient chair, foot control, dentist element and a water unit. The units may also include an assistant element, a cuspidor a dental operating light, and a monitor. The design concept of the INTEGO treatment unit is similar to commonly available treatment units. The dimensions of the components, their movements and shapes are designed for ergonomic treatment; i.e. the dentist and, where applicable, the assistant can perform their treatments in a healthy working posture. Surfaces are smooth to enable easy cleaning and disinfecting. This simplifies, in line with detachable parts and barriers as well as simple maintenance routines, efficient infection control. The operating concept is designed to make treatments easy and intuitive to prevent mal-operations and provide an unimpeded workflow. Depending on the selected foot control and user interface version, a significant portion of functions can be operated hands-free to improve infection control and treatment workflow. Styling and colors were selected under aesthetic aspects.
    Ask a Question
    K Number
    K150750
    Device Name
    Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray
    Manufacturer
    Sirona Dental Systems GMBH
    Date Cleared
    2015-07-02

    (101 days)

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

    Sirona Dental Systems GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The contra-angle handpieces are used to hold and drive burr instruments for the purposes of rotary processing. The handpieces are intended for dental applications in endodontics and for root canal measurement and are used by trained dental personnel in dental practices and laboratories. The T1 Spray is intended to be used to clean and lubricate dental handpieces.
    Device Description
    Endo 6:1 is a contra-angle handpiece which is adapted to dental electric motors or dental air motors with the ISO 3964 interface. It is reusable and it does not have a fiber optic light system. T1 LINE ENDO 6 L contra-angle handpiece is equipped with a fiber optic light system. It is also adapted to dental electric motors or dental air motors with the ISO 3964 interface. It is reusable. SIRONiTi APEX contra-angle handpiece is adapted to dental electric motors with the ISO 3964 interface. It is reusable. SIRONiTi APEX is equipped with a torque limitation function. Once a set torque has been reached, a gold plated magnetic coupling prevents jamming of the file in the root canal by retro-rotation. T1 Spray is the lubricant used for maintenance and cleaning of the drive channels of the handpieces.
    Ask a Question
    K Number
    K150217
    Device Name
    ORTHOPHOS SL
    Manufacturer
    Sirona Dental Systems GMBH
    Date Cleared
    2015-05-08

    (98 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sirona Dental Systems GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry, including pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and for carpus exposures.
    Device Description
    The device comprises image receptors for cephalometric exposures, 2D panoramic radiographs and 3D volume exposures. The combination of sensors in the device varies depending on the installed options and the regions of interest can be altered. The technology behind this is collimation and different start- and end angles of exposure. These allow for a reduced dosage depending on the program selected. This function is available with some volume, cephalometric and panoramic programs. Class I laser beam light localizers aid in the positioning of a patient's head which may be fixed through the use of bite blocks and adjustable forehead and temple supports. From the obtained exposures, reconstructed images can be viewed. The reconstructed 3D volumes, simulated projection exposures and panoramic/cephalometric data can be conveyed to SIDEXIS (an FDA approved Sirona software for acquisition, administration, analysis, diagnosis, presentation and transfer of image data for medical/dental use) and stored in the SIDEXIS database. An operator control panel allows for height adjustment, selection of mode and program, and indication of machine states. A separate handheld push-button serves for exposure release and an optional remote control is available.
    Ask a Question
    K Number
    K131319
    Device Name
    T1/T2/T3 TURBINE FAMILY
    Manufacturer
    SIRONA DENTAL SYSTEMS GMBH
    Date Cleared
    2014-05-30

    (388 days)

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

    SIRONA DENTAL SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The turbines of the T1 / T2 / T3 Turbine family are intended for the - Preparation of cavities and crowns - Removal of carious material - Removal of fillings - Processing of tooth and restoration surfaces - Reducing hard tooth structure
    Device Description
    The Sirona Dental Systems T1 / T2 / T3 turbine family consists of air powered, high speed handpieces. The handpieces are reusable, ergonomically shaped and include (T1 and T2 Turbines) a fiber optic light system. The water delivery geometry includes 4 pair of water / air spray nozzles just below the head with one way retraction valves to prevent the ingress of external water or air, when the spray system is shut down. The devices are sterilizable in an autoclave. The turbines are provided in three variants: control, boost and mini. In addition, the turbines are compatible with the following quick-coupling: - Sirona R coupling - Sirona F coupling - Sirona B coupling - KaVo coupling - W&H coupling - NSK MachLite coupling - NSK QD-J coupling
    Ask a Question
    K Number
    K132773
    Device Name
    SIDEXIS 4
    Manufacturer
    SIRONA DENTAL SYSTEMS GMBH
    Date Cleared
    2013-12-11

    (97 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIRONA DENTAL SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SIDEXIS 4 is software that offers functions for the acquisition, administration, analysis, diagnosis, presentation and transfer of digital or digitized image data, e.g. X-ray images or video recordings, for medical use, predominantly in dentistry.
    Device Description
    SIDEXIS 4 combines the two Sirona products GALAXIS and SIDEXIS XG and now integrates 2D and 3D functions. New functions have been implemented (e.g. comparison of two volumes, comparison of two 2D projections).
    Ask a Question
    K Number
    K123664
    Device Name
    INCORIS ZI
    Manufacturer
    SIRONA DENTAL SYSTEMS GMBH
    Date Cleared
    2013-04-08

    (131 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIRONA DENTAL SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Classic sintering - Framework and reduced crowns in the anterior and posterior tooth region - Bridge frameworks in the anterior and posterior tooth region with max. 2 pontics - Crown caps in the anterior and posterior region - Cone and telescoping crowns Speed sintering - Framework and reduced crowns in the anterior and posterior tooth region - Bridge frameworks in the anterior and posterior tooth region with max. 2 pontics and up to 9 units - Crown caps in the anterior and posterior region - Cone and telescoping crowns Super speed sintering - Framework and reduced crowns with a maximum wall-thickness of 2 mm
    Device Description
    The inCoris ZI are blocks of various sizes from which custom made dental restorations are grinded using Sirona CAD/CAM system. inCoris ZI ceramics constitute blocks comprised of zirconia ceramics (ZrO2). The blocks are initially manufactured in a partially sintered state; then, they are individually processed to specification, and finally, densely sintered. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine. The blocks are available in different colors.
    Ask a Question
    K Number
    K123952
    Device Name
    CEREC BLOCS C IN
    Manufacturer
    SIRONA DENTAL SYSTEMS GMBH
    Date Cleared
    2013-03-20

    (89 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIRONA DENTAL SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CEREC Blocs C In are indicated for the fabrication of veneers and of crowns in anterior teeth and in premolars that have not been endodontically treated, using the Sirona CAD/CAM system.
    Device Description
    CEREC Blocs C In is an industrially manufactured, silicate glass ceramic block used to produce crowns and veneer. The block consists of an inlying, highly-chromatic dentine core and an overlying translucent enamel layer. It is grinded to custom made dental restorations using Sirona CAD/CAM systems. The block is initially manufactured in a sintered state; then, is individually processed to specification. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine. CEREC Blocs C In are available in several colors and additional bleach color. The dental restorations obtain their individual color appearance by stain and glaze firing.
    Ask a Question
    K Number
    K123070
    Device Name
    GALILEOS FAMILY
    Manufacturer
    SIRONA DENTAL SYSTEMS GMBH
    Date Cleared
    2013-03-15

    (165 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIRONA DENTAL SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Devices of the GALILEOS family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support in adult and pediatric care. Devices of the GALILEOS family comprise a package of PC software modules to expand SIDEXIS capabilities to handling 3D data. This includes 3D reconstruction, storage, retrieval, viewing and processing of 3D-image data.
    Device Description
    The GALILEOS family is an extraoral source dental X-ray system intended to produce Xrays for obtaining three dimensional volume reconstructions of the teeth, jaw, and the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support in adult and pediatric care. The GALILEOS family device generates a conical x-ray beam that rotates around the patient's head within a certain angle. The device comprises an image receptor for 3D volume exposure with an adjustable diaphragm. Three volume regions are defined through this. Class I laser beam light localizers serve to position the patient's head that may be fixed through bite block and adjustable forehead and temple supports. From the obtained exposures a three dimensional image is reconstructed and can be viewed as well as panoramic/cephalometric images. The constructed 3D volume and simulated projection exposures as well as panoramic/cephalometric data are conveyed to SIDEXIS and stored in the SIDEXIS data base. An operator control panel allows height adjustment, selection of mode and program, and indicates machine states. A separate handhold push-button serves for exposure release An optional remote control is available.
    Ask a Question

    Page 1 of 5