Surgikor Fixation One, Abutment Blanks and Abutments

K240803 · Surgikor, LLC · DZE · Sep 12, 2024 · Dental

Device Facts

• Record ID: K240803
• Device Name: Surgikor Fixation One, Abutment Blanks and Abutments
• Applicant: Surgikor, LLC
• Product Code: DZE · Dental
• Decision Date: Sep 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Surgikor Fixation One is a root-form endosseous dental implant system; includes implant bodies, abutment blanks, and pre-fabricated abutments. Implants are placed in the jaw bone by dental surgeons; provide support for prosthetic restorations. Fixation One implants feature a conical connection; available in 4.3mm and 5.0mm diameters. Abutment blanks allow for CAD/CAM fabrication of customized titanium alloy abutments at validated milling centers. System includes healing caps and multi-unit abutments (straight, 17°, 30°). Device components are made of Ti6AL4V ELI. Output is a stable foundation for dental prosthetics; aids in restoring patient chewing function. Used in clinical dental settings.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including non-clinical MRI safety evaluation, and leveraging of biocompatibility, sterilization, and mechanical performance data from predicate K182615.

Technological Characteristics

Materials: Ti6AL4V ELI (ASTM F136). Design: Root-form endosseous dental implants with internal hex or conical connections. CAD/CAM abutment blanks allow customized fabrication. Sterilization: Steam sterilization. Connectivity: Not applicable (mechanical device).

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw to support prosthetic devices (artificial teeth) and restore chewing function. Suitable for immediate loading when primary stability is achieved. Abutments/blanks are for single or multi-unit restorations in the maxillary or mandibular arch.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is 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 a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• Surgikor Dental Implant System (K182615)
• Blue Sky Bio CAD CAM Abutments (K202026)

Reference Devices

• Nobel Biocare Multi-Unit Plus (K161416)
• Cortex (K090709)
• Cortex (K163385)
• Blue Sky Bio BioMax and Bio Internal Hex (K102034)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Surgikor LLC % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172

September 12, 2024

Re: K240803

Trade/Device Name: Surgikor Fixation One. Abutment Blanks and Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 20, 2024 Received: August 22, 2024

Dear Angela Blackwell:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Submission Number (if known)

K240803

Device Name

Surgikor Fixation One, Abutment Blanks and Abutments

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## K240803 510k Summary September 10, 2024 Surgikor Fixation One, Abutment Blanks and Abutments

Name and address of Submitter: Surgikor LLC 1299 W Jefferson Blvd Los Angeles CA, 90007 Contact Person: Jeremy Barbanell Phone Number: [phone] Name of device: Surgikor Fixation One, Abutment Blanks and Abutments Classification Name: Endosseous dental implants CFR: 21 CFR 872.3640 Product Code: DZE, NHA

## Submission Contact: Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 [phone]

[e-mail]

### Primary Predicate Device: Surgikor Dental Implant System K182615

Predicate/Reference Devices: Blue Sky Bio Cad CAM Abutments K202026, Nobel Biocare Multi-Unit Plus K161416 (for conical straight and angled multi-units), Cortex K090709, & K163385 (for healing cap size) Blue Sky Bio BioMax and Bio Internal Hex K102034 (implant sizes and platforms)

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

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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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#### Indications for 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 singleunit 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.

Testing Summary: Cytotoxicity and steam sterilization of the abutments and abutments made from blanks are the same as the predicate device K182615. Gamma irradiation validation, LAL testing, shelf-life, cytotoxicity, surface assessment, and bench testing for the Fixation One implant body is leveraged from K182615.

### MR Environment Condition

Non-clinical worst-case MRI review was performed to evaluate the metallic devices in the Surgikor Dental Implant System in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions.

Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

### Substantial Equivalence:

Surgikor's Fixation One implants, Abutment Blanks and Abutments are substantially equivalent to the predicate devices. They have the same indications for use, materials, design, principles of operation and sterilization. The abutment blanks have very similar parameters.

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| Company & Device Name | Surgikor's Fixation One<br>(Devices in this submission) | Surgikor's Dental<br>Implant System<br>K182615<br>Primary Predicate<br>Device | Blue Sky Bio CAD CAM<br>Abutments K202026<br>(With additional<br>implant information<br>from<br>K102034) |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Surgikor's Dental Implant<br>System is indicated for use<br>in surgical and restorative<br>applications for placement<br>in the bone of the upper<br>or lower jaw to provide<br>support for prosthetic<br>devices, such as artificial<br>teeth, in order to restore<br>the patient's chewing<br>function. The Dental<br>Implant System is indicated<br>also for immediate loading<br>when good primary<br>stability is achieved and<br>with appropriate occlusal<br>loading.<br>Surgikor Abutment Blanks<br>and Abutments are<br>intended to be used in<br>conjunction with Surgikor<br>endosseous dental<br>implants in the maxillary or<br>mandibular arch to provide<br>support for single-unit or<br>multi-unit prosthetic<br>restorations. All digitally<br>designed abutments for<br>use with Surgikor<br>Abutment Blanks are<br>intended to be sent to a<br>Surgikor validated milling<br>center<br>for manufacture. | Surgikor's Dental<br>Implant System is<br>indicated for use in<br>surgical and restorative<br>applications for<br>placement in the bone<br>of the upper or lower<br>jaw to provide support<br>for prosthetic devices,<br>such as artificial teeth,<br>in order to restore the<br>patient's chewing<br>function. The Dental<br>Implant System is<br>indicated also for<br>immediate loading<br>when good primary<br>stability is achieved and<br>with appropriate<br>occlusal loading.<br>The 7mm implants are<br>intended to be used in<br>the molar region.<br>(Note that 7mm<br>implants have been<br>removed from sale so<br>this statement in the<br>indications is no longer<br>needed) | Blue Sky Bio CAD-<br>CAM Abutments are<br>intended to be used<br>in conjunction with<br>Blue Sky Bio<br>endosseous dental<br>implants in the<br>maxillary or<br>mandibular arch to<br>provide support for<br>single-unit or multi-<br>unit prosthetic<br>restorations.<br>All digitally designed<br>abutments for use<br>with Blue Sky Bio<br>CAD-CAM Abutments<br>are intended to be<br>sent to a Blue Sky Bio<br>validated milling<br>center for<br>manufacture. |
| Materials | Ti-6AL-4V ELI | Ti-6AL-4V ELI | Ti-6AL-4V ELI |
| Principle of Operation | Abutments and CAD/CAM<br>abutments made from<br>blanks for | Abutments for the<br>restoration of dental<br>implants | Abutments and<br>CAD/CAM abutments<br>made from blanks for |
| | the restoration of dental<br>implants.<br>Dental implants for<br>replacement of lost<br>teeth to restore chewing<br>function. | Dental implants for<br>replacement of lost<br>teeth to restore<br>chewing function. | the restoration of<br>dental implants. |
| Implant diameters and<br>lengths in this<br>submission | Fixation One<br>4.3 & 5.0 mm diameter<br>in lengths of 8.5, 10,<br>11.5, 13, 15, 18mm | Fixation<br>4.3 & 5.0 mm diameter<br>in lengths of 8.5, 10,<br>11.5, 13,<br>15, 18mm | Biomax implants<br>4.3 & 5.0 mm<br>diameter in lengths of<br>6,8,10,11,and 13mm |
| Implant connection in<br>this submission | RP conical | WP Conical | RP conical |

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| | Surgikor's, Abutment<br>Blanks (Devices in this<br>submission) | Blue Sky Bio CAD CAM<br>Abutments K202026<br>(With additional<br>implant information<br>from K102034) |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Abutments made from<br>abutment blanks fit<br>Implant design of the<br>manufacturer | Yes | Yes |
| Interface type/shape | Internal hex, conical | Internal hex, conical |
| Location of<br>Manufacturer of<br>Abutments from the<br>Abutment Blanks | Surgikor validated<br>milling center | Blue Sky Bio validated<br>milling center |
| Parameters for Making<br>Abutments from<br>Abutment Blanks | Surgikor Blank<br>Abutments are<br>designed for<br>fabrication of a<br>customized all<br>titanium alloy<br>abutment by CAD-<br>CAM processes.<br>Surgikor Blank<br>Abutments have an<br>engaging implant<br>connection.<br>The design<br>parameters for<br>customized<br>abutments fabricated | Titanium Blank<br>Abutments are<br>designed for<br>fabrication of a<br>customized all titanium<br>alloy abutment by<br>CAD-CAM processes.<br>Titanium Blank<br>Abutments have an<br>engaging implant<br>connection.<br>The design parameters<br>for customized<br>abutments fabricated<br>from Titanium Blank<br>Abutments are: |

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| | from Titanium Blank<br>Abutments are:<br>Minimum wall<br>thickness - 0.4 mm<br>Minimum post height<br>for single-unit<br>restorations - 4.0 mm<br>Minimum gingival<br>height - 0.5 mm<br>Maximum gingival<br>height - 6.7 mm<br>Maximum angulation<br>- 25° (in relation to<br>the long axis of the<br>implant) | Minimum wall<br>thickness - 0.4 mm<br>Minimum post height<br>for single-unit<br>restorations - 4.0 mm<br>Minimum gingival<br>height – 0.5 mm<br>Maximum gingival<br>height - 6.7 mm<br>Maximum angulation -<br>30° |
|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Abutment design<br>parameters based on<br>fatigue testing<br>parameters | Yes | Yes |
| Implant bodies used<br>with abutment blanks<br>Minimum diameter of<br>implant given. | Internal Hex<br>Versatile Hex 3.5mm<br>Immediate Hex<br>3.75mm<br>RP&WP Conical<br>Solution 3.5mm<br>Fixation 3.5mm<br>Fixation One 4.3mm | Internal Hex<br>Bio Internal Hex 3.7mm<br>Conical<br>BioMax NP 3.0mm<br>BioMax RP 4.3mm |

| | Additional Surgikor Dental<br>Implant System Devices | Cortex K090709 & K163385 |
|-------------------------------------------|------------------------------------------------------|--------------------------|
| Healing Caps Standard<br>Emergence 3.75mm | 3.75 x 7mm healing cap<br>standard emergence | 3.8 x 7mm healing cap |

| | Additional Surgikor<br>Dental Implant System<br>Devices | Nobel Biocare<br>Multi-Unit Plus<br>K161416 |
|--|---------------------------------------------------------|---------------------------------------------|
|--|---------------------------------------------------------|---------------------------------------------|

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| Conical Multi-Unit<br>Abutment RP | Conical RP Multi-Unit in<br>gingival heights of<br>1.5/2.5/3.5 mm | Conical RP Multi-<br>Units in gingival<br>heights of<br>1.5/2.5/3.5/4.5 mm |
|---------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Conical Multi-Unit<br>Abutment WP | Conical WP Multi-Unit<br>in gingival heights of<br>1.5/2.5/3.5 mm | Conical WP Multi-<br>Units in gingival<br>heights of<br>1.5/2.5/3.5/4.5 mm |
| Conical Multi-Unit<br>Abutment 17° RP | Conical RP 17° Multi-<br>Unit in gingival heights<br>of 2.5/3.5 mm | Conical RP 17°<br>Multi-Units in<br>gingival heights of<br>1.5/2.5/3.5/4.5 mm |
| Conical Multi-Unit<br>Abutment 17° WP | Conical WP 17° Multi-<br>Unit in gingival heights<br>of 2.5/3.5 mm | Conical WP 17°<br>Multi-Units in<br>gingival heights of<br>1.5/2.5/3.5/4.5 mm |
| Conical Multi-Unit<br>Abutment 30° RP | Conical RP 30° Multi-<br>Unit in gingival heights<br>of 3.5/4.5 mm | Conical RP 30°<br>Multi-Units in<br>gingival heights of<br>1.5/2.5/3.5/4.5 mm |
| Conical Multi-Unit<br>Abutment 30° WP | Conical WP 17° Multi-<br>Unit in gingival heights<br>of 3.5/4.5 mm | Conical WP 30°<br>Multi-Units in<br>gingival heights of<br>1.5/2.5/3.5/4.5 mm |

### Conclusion:

Surgikor Fixation One implants are substantially equivalent to the Surgikor Fixation implants. They have the same indications for use, materials, design, principles of operation and sterilization. The 7mm implants have been withdrawn from sale so the restriction on those in the indications is no longer needed. Surgikor Abutment Blanks and Abutments are substantially equivalent to the Blue Sky Bio CAD CAM Abutments. They have the same indications for use, materials, design, principles of operation and sterilization. Parameters for abutment made from abutment blanks are very similar. Abutments made from abutment blanks are manufactured in a validated milling center for both the predicate and subject devices. Abutments made from abutment blanks fit implant bodies the same size and similar connections as those found in the predicate submission. The new abutment designs are all very similar to the reference devices and come in the same range of diameters and gingival heights.