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

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA regarding the Surgikor Fixation One, Abutment Blanks, and Abutments. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, not on proving that a device meets specific acceptance criteria through a clinical or performance study involving an AI algorithm or human readers.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop system because:

The document is for a dental implant system (physical medical devices), not an AI algorithm or software. The "device" in question (Surgikor Fixation One, Abutment Blanks, and Abutments) is a set of physical components used in dental implant procedures, made from Ti6AL4V ELI material.
The "study" discussed is a demonstration of substantial equivalence. This involves comparing the new device's indications for use, materials, design, principles of operation, and sterilization to legally marketed predicate devices. It does not involve performance metrics like sensitivity, specificity, or human improvement with AI assistance.
There is no mention of algorithms, AI, human readers, or image analysis. The testing summary mentions cytotoxicity, steam sterilization, gamma irradiation validation, LAL testing, shelf-life, surface assessment, bench testing, and an MRI environment review, all related to the physical properties and safety of the dental implants.

The document does not contain any of the information required to populate the fields related to acceptance criteria for an AI-powered diagnostic device.

Summary of why the requested information cannot be extracted from the provided text:

The document describes a 510(k) submission for mechanical dental implants and abutments. It focuses on demonstrating "substantial equivalence" to existing predicate devices, rather than presenting a performance study of an AI-driven system or a system involving human interpretation of data. Therefore, details such as algorithm performance, sample sizes for AI training/testing sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for AI models are not present.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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: +1 562-714-9732 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 (704)450-9934

angela@blackwelldevice.com

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.

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:

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(Devices in this submission)	Surgikor's DentalImplant SystemK182615Primary PredicateDevice	Blue Sky Bio CAD CAMAbutments K202026(With additionalimplant informationfromK102034)
Indications for Use	Surgikor's Dental ImplantSystem is indicated for usein surgical and restorativeapplications for placementin the bone of the upperor lower jaw to providesupport for prostheticdevices, such as artificialteeth, in order to restorethe patient's chewingfunction. The DentalImplant System is indicatedalso for immediate loadingwhen good primarystability is achieved andwith appropriate occlusalloading.Surgikor Abutment Blanksand Abutments areintended to be used inconjunction with Surgikorendosseous dentalimplants in the maxillary ormandibular arch to providesupport for single-unit ormulti-unit prostheticrestorations. All digitallydesigned abutments foruse with SurgikorAbutment Blanks areintended to be sent to aSurgikor validated millingcenterfor manufacture.	Surgikor's DentalImplant System isindicated for use insurgical and restorativeapplications forplacement in the boneof the upper or lowerjaw to provide supportfor prosthetic devices,such as artificial teeth,in order to restore thepatient's chewingfunction. The DentalImplant System isindicated also forimmediate loadingwhen good primarystability is achieved andwith appropriateocclusal loading.The 7mm implants areintended to be used inthe molar region.(Note that 7mmimplants have beenremoved from sale sothis statement in theindications is no longerneeded)	Blue Sky Bio CAD-CAM Abutments areintended to be usedin conjunction withBlue Sky Bioendosseous dentalimplants in themaxillary ormandibular arch toprovide support forsingle-unit or multi-unit prostheticrestorations.All digitally designedabutments for usewith Blue Sky BioCAD-CAM Abutmentsare intended to besent to a Blue Sky Biovalidated millingcenter formanufacture.
Materials	Ti-6AL-4V ELI	Ti-6AL-4V ELI	Ti-6AL-4V ELI
Principle of Operation	Abutments and CAD/CAMabutments made fromblanks for	Abutments for therestoration of dentalimplants	Abutments andCAD/CAM abutmentsmade from blanks for
	the restoration of dentalimplants.Dental implants forreplacement of lostteeth to restore chewingfunction.	Dental implants forreplacement of lostteeth to restorechewing function.	the restoration ofdental implants.
Implant diameters andlengths in thissubmission	Fixation One4.3 & 5.0 mm diameterin lengths of 8.5, 10,11.5, 13, 15, 18mm	Fixation4.3 & 5.0 mm diameterin lengths of 8.5, 10,11.5, 13,15, 18mm	Biomax implants4.3 & 5.0 mmdiameter in lengths of6,8,10,11,and 13mm
Implant connection inthis submission	RP conical	WP Conical	RP conical

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	Surgikor's, AbutmentBlanks (Devices in thissubmission)	Blue Sky Bio CAD CAMAbutments K202026(With additionalimplant informationfrom K102034)
Abutments made fromabutment blanks fitImplant design of themanufacturer	Yes	Yes
Interface type/shape	Internal hex, conical	Internal hex, conical
Location ofManufacturer ofAbutments from theAbutment Blanks	Surgikor validatedmilling center	Blue Sky Bio validatedmilling center
Parameters for MakingAbutments fromAbutment Blanks	Surgikor BlankAbutments aredesigned forfabrication of acustomized alltitanium alloyabutment by CAD-CAM processes.Surgikor BlankAbutments have anengaging implantconnection.The designparameters forcustomizedabutments fabricated	Titanium BlankAbutments aredesigned forfabrication of acustomized all titaniumalloy abutment byCAD-CAM processes.Titanium BlankAbutments have anengaging implantconnection.The design parametersfor customizedabutments fabricatedfrom Titanium BlankAbutments are:

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	from Titanium BlankAbutments are:Minimum wallthickness - 0.4 mmMinimum post heightfor single-unitrestorations - 4.0 mmMinimum gingivalheight - 0.5 mmMaximum gingivalheight - 6.7 mmMaximum angulation- 25° (in relation tothe long axis of theimplant)	Minimum wallthickness - 0.4 mmMinimum post heightfor single-unitrestorations - 4.0 mmMinimum gingivalheight – 0.5 mmMaximum gingivalheight - 6.7 mmMaximum angulation -30°
Abutment designparameters based onfatigue testingparameters	Yes	Yes
Implant bodies usedwith abutment blanksMinimum diameter ofimplant given.	Internal HexVersatile Hex 3.5mmImmediate Hex3.75mmRP&WP ConicalSolution 3.5mmFixation 3.5mmFixation One 4.3mm	Internal HexBio Internal Hex 3.7mmConicalBioMax NP 3.0mmBioMax RP 4.3mm

	Additional Surgikor DentalImplant System Devices	Cortex K090709 & K163385
Healing Caps StandardEmergence 3.75mm	3.75 x 7mm healing capstandard emergence	3.8 x 7mm healing cap

	Additional SurgikorDental Implant SystemDevices	Nobel BiocareMulti-Unit PlusK161416
--	---------------------------------------------------------	---------------------------------------------

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Conical Multi-UnitAbutment RP	Conical RP Multi-Unit ingingival heights of1.5/2.5/3.5 mm	Conical RP Multi-Units in gingivalheights of1.5/2.5/3.5/4.5 mm
Conical Multi-UnitAbutment WP	Conical WP Multi-Unitin gingival heights of1.5/2.5/3.5 mm	Conical WP Multi-Units in gingivalheights of1.5/2.5/3.5/4.5 mm
Conical Multi-UnitAbutment 17° RP	Conical RP 17° Multi-Unit in gingival heightsof 2.5/3.5 mm	Conical RP 17°Multi-Units ingingival heights of1.5/2.5/3.5/4.5 mm
Conical Multi-UnitAbutment 17° WP	Conical WP 17° Multi-Unit in gingival heightsof 2.5/3.5 mm	Conical WP 17°Multi-Units ingingival heights of1.5/2.5/3.5/4.5 mm
Conical Multi-UnitAbutment 30° RP	Conical RP 30° Multi-Unit in gingival heightsof 3.5/4.5 mm	Conical RP 30°Multi-Units ingingival heights of1.5/2.5/3.5/4.5 mm
Conical Multi-UnitAbutment 30° WP	Conical WP 17° Multi-Unit in gingival heightsof 3.5/4.5 mm	Conical WP 30°Multi-Units ingingival heights of1.5/2.5/3.5/4.5 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.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.