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510(k) Data Aggregation

    K Number
    K221910
    Device Name
    QRS Dental Implants System
    Manufacturer
    QRS Medical Ltd.
    Date Cleared
    2022-12-14

    (167 days)

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

    QRS Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QRS Dental Implants Systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. The implants (Ø3.3mm and one-piece) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
    Device Description
    QRS Dental Implants are self-tapping, root-form, one piece or two piece screw (Red Class, Blue Class and Gold Class) type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The QRS' dental implant is a two stage screw type device that can equally well be used as one stage, surgically placed in the upper or lower jaw to provide support for prosthetic devices in partially or completely edentulous patients. The QRS' two piece implant is to be used in combination with several different abutments and superstructures provided in order to aid in the prosthetic rehabilitation. QRS dental implants (Red Class, Blue Class and Gold Class) are designed with a standard internal hexagon system and provided in 3.3, 3.75, 4.2, 5.0 and 6.0mm diameter for lengths of 8, 10, 11.5, 13 and 16mm. QRS dental implant one-piece is provided in 3.3 and 3.5mm diameter for lengths of 10, 11.5, 13 and 16mm. The ORS' two piece dental implants are to be used in combination with cover screws. healing caps, abutments, smart attachment and straight multi-unit abutment according to commonly used protocol in the dental implantation field. The QRS Dental Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant. The implants are grit blasted and acid etched surface. All QRS' abutments, cover screws, healing caps, Straight ball attachment, smart attachment and strait multi- unit abutments are made of Ti6A14V ELI titanium alloy complying with ASTM F 136-13: Wrought Titanium-6 Aluminum -4Vanadium ELI alloy for surgical implant applications and ISO 5832-3: 2016: Implants for surgery --Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy. Abutments (straight abutments, angulated abutments (15°, 25°), and anatomic angulated abutments (15°, 25°)) are intended to be used in conjunction with endosseous dental implants fixture to aid in prosthetic rehabilitation. The abutments are intended for long term use and are in contact with tissue. The abutments are available straight or angulated, in different heights and diameters to accommodate the patient's specific needs. They are available in 0, 15 or 25 degrees angulation. Straight Abutment SP Titanium Abutment is provided in height of 5, 7 and 9mm. Standard shoulder abutment in heights of 1, 2, 3 and 4mm Standard Wide Shoulder Abutment is provided in heights of 1, 2, 3 and 4mm Standard 15° Abutment is provided in heights of 2, 3 and 4mm Standard 25° Abutment is provided in heights of 2, 3 and 4mm The healing caps are intended for use with the implant system to protect the inner configuration of the implant, maintain, stabilize and enable formation of the soft tissue during the healing process. Healing Caps are provided in 4.5 diameter in heights of 3, 4, 5, 6 and 7mm. Wide Healing Cap is provided in 6 diameter in heights 3, 4, 5 and 6mm. Straight Ball attachment are designed to increase retention of (partial) overdentures, supported on implants. QRS titanium Ball Attachments provide firm retention and stabilization of the overdenture when used with tissue-supported implant-retained overdentures and are compatible with QRS internal hexagon connection implants. Straight ball attachments are provided in heights of 2, 3, and 4mm Smart Attachment - Locator abutments are designed for use with overdentures or partial dentures retained in whole or in part by dental implants in the mandible or maxilla. They offer multiple levels of retention and low vertical profile. The selfaligning design enables patients to easily seat their dentures. Smart attachment are provided with heights of 1, 2, 3 and 4mm. Straight Multi-unit abutment are indicated for multiple unit reconstructions when screw retained prosthetics is preferred. Multi-unit abutments allow either direct screw of the prosthesis into the multi-unit abutment or connection to a fixed overdenture bar. Multi-unit abutments are provided in heights of 2, 3, 4 and 5 mm. Abutments, healing caps, straight ball attachment, smart attachments and straight multi-unit abutment are provided non-sterile to the user and have to be sterilized prior to use by moist heat All the Abutments, healing caps, straight ball attachment, smart attachments and straight multi-unit are intended for single use only. QRS Implants are especially designed for implantation in a wide range of bone types and bone augmentation procedures. Each two piece implant is supplied with a cover screw, which is intended for use with the implant system to protect the inner configuration of the implant, maintain, stabilize and enable formation of the soft tissue during the healing process. Maximum compatibility and accuracy can be achieved when using compatible QRS tools, drills, accessories and prosthetic parts manufactured by QRS.
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