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510(k) Data Aggregation

    K Number
    K232383
    Device Name
    iPhysio® System
    Manufacturer
    Date Cleared
    2025-03-04

    (574 days)

    Product Code
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Euroteknika

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indications for Use for iPhysio® Profile Designer: iPhysio® System Profile Designers are indicated to be placed in the end of the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. The healing abutments should be used only with comections. The healing abutments are intended for use up to 6 months. Compatible Implant Systems: | Manufacturer | Implant System | Implant Diameter (mm) | Platform Diameter (mm) | Platform Name | |---------------|--------------------|-----------------------|------------------------|---------------| | Nobel Biocare | NobelActive® | 3.5 | 3.5 | NP | | Nobel Biocare | NobelActive® | 4.3, 5.0 | 4.3, 5.0 | RP | | Nobel Biocare | NobelReplace® | 3.5 | 3.5 | NP | | Nobel Biocare | NobelReplace® | 4.3, 5.0 | 4.3, 5.0 | RP | | Nobel Biocare | NobelParallel™ | 3.75 | 3.5 | NP | | Nobel Biocare | NobelParallel™ | 4.3, 5.0 | 4.3, 5.0 | RP | | Straumann | Bone Level | 3.3 | 3.3 | NC | | Straumann | Bone Level | 4.1, 4.8 | 4.1, 4.8 | RC | | Straumann | Bone Level Tapered | 3.3 | 3.3 | NC | | Straumann | Bone Level Tapered | 4.1, 4.8 | 4.1, 4.8 | RC | | Zimmer Biomet | Trabecular Metal | 3.7, 4.1 | 3.5 | 3.5 | | Zimmer Biomet | Trabecular Metal | 4.7 | 4.5 | 4.5 | | Zimmer Biomet | Tapered Screw Vent | 3.7, 4.1 | 3.5 | 3.5 | | Zimmer Biomet | Tapered Screw Vent | 4.7 | 4.5 | 4.5 | Indications for Use for iPhysio® PEEK Temporary Abutment: The iPhysio® System PEEK Temporary Abutment is an abutment placed on the iPhysio® System Profile Designer to provide support for prosthetic structures for up to 6 months. It can be used in single- or two-stage procedures and is intended to be placed out of occlusion.
    Device Description
    The iPhysio® System is a set of two-piece titanium healing abutments (iPhysio® Profile Designers) be screwed into the implant using compatible anodized titanium screws during the 1st or the 2nd surgical intervention. The iPhysio® Profile Designer abutment is manufactured from titanium alloy (Ti-6Al-4V ELI) per ISO 5832-3 and includes a zirconium nitride (ZrN) coating. iPhysio® Profile Designers are available in multiples anatomical shapes and gingival heights, and are compatible with Nobel BioCare (NobelActive®, NobelReplace®, NobelParallel™), Straumann (Bone Level / Bone Level Tapered), and Zimmer Biomet (Trabecular Metal, Tapered Screw-Vent®) implants. All iPhysio® Profile Designers are straight (0°). Supporting screws are manufactured from titanium alloy (Ti-6Al-4V ELI) per ISO 5832-3 and are anodized to a color that aligns with its corresponding height. The iPhysio® Profile Designer healing abutment screw is for placing the iPhysio® Profile Designer in the implant in the patient's mouth. The iPhysio® Profile Designer remains in place throughout the bone and gingival healing process as well as during the taking of a digital or conventional impression, preserving the emergence profile during the impression. The abutment is only removed once to place and finally screw in the final abutment. Anatomical healing, implant impression, and placement of the temporary crown may all be done without removing the iPhysio® Profile Designer. A compatible PEEK temporary abutment may be clipped to the iPhysio® Profile Designer to which a non-load bearing temporary crown may be then placed for improved aesthetics during healing. To use the PEEK temporary abutment, the iPhysio® Profile Designer healing abutment screw is replaced with a compatible temporary abutment screw. The temporary crown is placed over the PEEK temporary abutment following modification of the abutment to the appropriate shape. The PEEK temporary abutment is connected onto the iPhysio® Profile Designer by a combination of friction and cement. All iPhysio® temporary abutments are manufactured from PEEK per ASTM F2026.
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    K Number
    K083670
    Device Name
    UNIVERSAL, AESTHETICA, NATEA, NATURA
    Manufacturer
    Date Cleared
    2009-07-23

    (224 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROTEKNIKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients.
    Device Description
    Euroteknika's range of implants refer to sets of root form endosseous dental implants made of pure titanium (grade iv) and titanium alloy (TA6V) and components for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in endentulous or partially edentulous patients.
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    K Number
    K083669
    Device Name
    OBI
    Manufacturer
    Date Cleared
    2009-06-08

    (179 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROTEKNIKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Surgical placement in mandibular arch to support overdentures in edentulous patients.
    Device Description
    A set of root form endosseous dental implants and components for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in endentulous or partially edentulous patients.
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