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510(k) Data Aggregation

    K Number
    K240803
    Device Name
    Surgikor Fixation One, Abutment Blanks and Abutments
    Manufacturer
    Surgikor LLC
    Date Cleared
    2024-09-12

    (171 days)

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

    Surgikor LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgikor's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Surgikor Abutment Blanks and Abutments are intended to be used in conjunction with Surgikor endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed abutments for use with Surgikor Abutment Blanks are intended to be sent to a Surgikor validated milling center for manufacture.
    Device Description
    The Surgikor Fixation One implant is an alternative version of the 4.3 and 5.0 mm diameter Fixation implants that uses the regular platform used by the 3.5mm Fixation implants. The Surgikor abutment blanks and abutments consist of hexagonal and conical abutments made from abutment blanks, an additional hexagonal healing cap, and multi-unit abutments for conical RP and WP. Surgikor implants and abutments are made from Ti6AL4V ELI. Fixation One is a root form implant that is appropriate for both immediate load applications and insertion into fresh extraction sockets. Fixation One is offered with a conical connection in regular platform. The Fixation One regular platform implant is available in 4.3, and 5.0 mm diameter and has available lengths of 8.5, 10, 11.5, 13, 15, and 18 mm. Healing cap for internal hex in 3.75mm x 7mm in standard emergence. Multi-Unit Abutment in conical RP and WP are available in heights of 1.5, 2.5, and 3.5 mm. An angled multi-unit of either 17° (2.5 or 3.5 mm) or 30° (3.5 or 4.5 mm) is available for conical connections of regular and wide platform. Multi-unit abutments are intended for multiple unit restorations only. Angled multi-units use RP and WP conical multi-unit screws. Surgikor Blank Abutments are designed for fabrication of a customized all titanium alloy abutment by CAD-CAM processes. Surgikor Blank Abutments have an engaging implant connection. Abutments made from Surgikor Blank Abutments use internal hex abutment screws and RP & WP conical abutment screws from K182615. The design parameters for customized abutments fabricated from Titanium Blank Abutments are: Minimum wall thickness – 0.4 mm Minimum post height for single-unit restorations (length above the abutment collar / gingival height)— 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height – 6.7 mm Maximum angulation - 25° (in relation to the long axis of the implant) All abutment blanks are made of titanium alloy conforming to ASTM F136. Abutments made from the blanks are only for use with Surgikor dental implants of the implant/abutment interface on the package label and are not to be used with other dental implant designs. This includes Versatile Hex 3.5mm and larger, Immediate Hex 3.75mm and larger, and Solution Fixation & Fixation One conical 3.5mm and larger. There are 3 models of abutment blank: internal hex, conical RP and conical WP. Minimum diameter at abutment/implant interface: Versatile Hex 3.5mm Immediate Hex 3.75mm Solution 3.5mm Fixation 3.5mm Fixation One 4.3mm Maximum length of abutment from abutment/implant interface: Versatile and Immediate Hex 13.00mm Solution 9.5mm Fixation and Fixation One 9mm
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    K Number
    K182615
    Device Name
    Surgikor Dental Implant System
    Manufacturer
    Surgikor LLC
    Date Cleared
    2019-07-08

    (290 days)

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

    Surgikor LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgikor's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The 7mm implants are intended to be used in the molar region.
    Device Description
    The Surgikor Dental Implant System consists of two stage endosseous form dental implants, hexagonal and conical implants and hexagonal and conical abutments; cover screws and healing caps; abutment systems including multi-unit abutments. Implants are made from Ti6ALAV ELI. The Surgikor Dental Implant System includes: Versatile model is a platform switched, tapered implant designed for use in any bone type and is offered with a Morse tapered hex connection. The regular hex platform comes in diameters of 3.5, 3.75, 4.2, 4.5, 5.0 and 6.0mm. Lengths of 8, 10, 11.5, 13 and 16 are available with 18 and 20 mm lengths available in the 4.2 diameter only. Immediate model is a platform switched root-form implant design. The Immediate suitable for both immediate load applications and insertion into fresh extraction sockets and is offered with a Morse tapered hex connection in regular platform. It is available in 3.75, 4.2, 4.5, 5.0, 6.0, and 7.0 mm diameter. The hex is regular platform and comes in lengths of 7 (4.5, 5, 6.and 7mm only), 8, 10, 11.5, 13, 16 (7.0mm diameter not in 11.5,13 or 16 mm length). Fixation model is a root form implant is appropriate for both immediate load applications and insertion into fresh extraction sockets. The Fixation is offered with a conical connection in narrow, regular and wide platforms. The 3.0 diameter implant is available in narrow platform and lengths of 10, 11.5, 13 and 15mm. The Fixation regular platform implant is available in 3.5 and 3.9 mm diameter and has available lengths of 8.5, 10, 11.5, 15, and 18 mm. Wide platform is available in 4.3 and 5.0 mm diameter with lengths of 8.5, 10, 11.5, 13, 15 and 18mm. Solution model is equipped with a specially designed, narrow, deep, conical connection and is designed for use in narrow bone volumes. The Solution5 is available in narrow platform with a diameter of 3.25mm and lengths of 10, 11.5, 13, 15 mm. The regular platform is available in 3.5, and 4.0 diameter in lengths of 7.0 (4.0 diameter only), 8.5, 10. 11.5, 13, 15mm. The wide platform is available in diameters of 4.5. 5.0. 5.5 and 6.0mm. These diameters come in lengths of 7.0. 8.5. 10. 11.5. 13. and 15mm. The Solution2 is available with lengths of 10. 11.5. 13. and 16 mm in a diameter of 3.25 mm. The Solution5 and Solution2 differ in that the Solution5 implants have an outer thread like the Versatile model, while the Solution2 have an outer thread like the Immediate model. Healing caps are available in 3 platform sizes: normal, narrow and wide. The conical connection models are available in narrow, regular and wide platforms with lengths of 2, 3, 4, 5, 6, 7 mm and diameters of 3.0, 3.5 and 4.3 mm. There is also a wide platform conical connection healing cap for both narrow emergence and wide emergence. These are 4.3 mm diameter in lengths of 2, 3, 4, 5, 6 and 7 mm. The hex connection models are available in narrow emergence, regular platform with lengths of 2. 3. 4. 5. 6. 7 mm and a diameter of 3.75 mm and standard & wide emergence regular platform with lengths of 2,3, 4, 5, and 6 mm and a diameter of 3.75 mm. There is also a healing cap for the multiunit abutment which comes in one size. Healing caps with marks for scanning are available in 2mm length for regular hex, narrow conical, regular conical and wide conical platforms. Temporary abutment is for immediate loading if appropriate. The Temporary abutment is available with a conical connection in narrow, regular and wide platforms all with lengths of 1, 2, 3, 4, 5, 6 and 7 mm and diameters of 3.0, 3.5 and 4.3 mm. It is also available with a hex connection regular platform with lengths of 1, 2, 3, 4, 5, 6, 7 mm and a diameter of 3.75 mm. Non-shouldered abutments are straight titanium abutments with hex designed for permanent restoration. The abutments are supplied as regular non-shouldered straight abutments with lengths of 5, 7, 9, 12 and 15 (not in narrow conical) mm with a narrow conical platform of 3.0 mm width, a regular conical platform of 3.5 mm width, a wide conical platform of 4.3mm and with a regular hex platform of 3.75 mm width. Also available is a wide emergence non-shouldered straight abutment with lengths of 5, 7, 9, 12 and 15 mm with a wide conical platform of 4.3 mm. The 5mm height nonshouldered abutments are intended for multiple unit restorations only. 15° and 25° angular non-shouldered abutments: 15° abutments are supplied in lengths of 9, 11 and 13 mm with either a hex connection (3.75mm) or a conical connection in narrow (3.0mm), regular (3.5mm) or wide (4.3mm) platform. 25° abutments are supplied in lengths of 9, 11 and 13 mm with a hex connection, a conical connection regular platform or a conical connection wide platform. 15° and 25° narrow emergence abutments are supplied as a hex connection regular platform with a width of 3.75 mm. 15° and 25° wide emergence abutments are supplied as a wide platform conical connection with a width of 4.3 mm and lengths of 9, 11, and 13mm. Anatomic Straight Shouldered Abutments All have a length of 7.5mm and shoulder heights of 1, 2 and 3 mm. They are available in the following configurations: conical connection, narrow, regular or wide platform or hex connection regular platform. Wide emergence versions are available in wide conical connection and regular hex connection. 15°, and 25° Angled Anatomic Abutment with Shoulder, all have a length of 7.5 mm and shoulder heights of 1, 2 and 3 mm. They are available in conical connection, narrow (available in 15° only), regular and wide platform and hex connection regular platform. Wide emergence version are available in wide conical. Ball Attachment Abutments are provided with lengths of 1, 2, 3, 4, 5, and 6 mm and in the following configurations: Conical connection, narrow platform 3.0 mm diameter, Conical connection, regular platform 3.5 mm diameter, Conical connection, wide platform 4.3 mm diameter , Hex connection, regular platform 3.75 mm diameter. Ball attachment abutments are intended for multiple unit restorations only. Multi-Unit Abutment are supplied with lengths of 1, 2, 3 and 4 mm. They are available in narrow regular and wide conical platforms and in hex regular platform. An angled multi-unit of either 18° or 30° is available for conical connections of narrow, regular and wide platform. A plastic sleeve for casting an extension for using multi-units in single units is included in the 510k. Multi-unit abutments are intended for multiple unit restorations only. Standard Locator Abutments are supplied in shoulder heights of 1, 2, 3, 4, 5, and 6mm. Locators are intended for multiple unit restorations only. Castable abutments are available in hexed and non-hexed in hex or conical connection (all three platforms). They are available in Ti alloy and gold. A plastic sleeve is available for use with the castable abutments. They are intended for casting straight abutments taller than 4mm. Abutment Screws are available for hex connection and for all three platforms of conical connection. Cover Screw are supplied with a conical connection as narrow, regular and wide and with a hex connection.
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