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.

AI/ML Overview

The provided text is a 510(k) summary for the Surgikor Dental Implant System, detailing its substantial equivalence to predicate devices. However, it does not describe an AI/ML device or a study proving its performance against acceptance criteria in the context of an AI/ML system.

The document focuses on the physical characteristics, materials, and mechanical testing of dental implants and their associated components (abutments, healing caps, etc.). The "Testing Summary" refers to:

Dynamic fatigue testing according to ISO 14801: This is a standard for evaluating the fatigue strength of dental implants. The acceptance criterion is "Sufficient run out load for their intended use."
Surface cleanliness analysis: "all tests were passed."
Biocompatibility of materials (gold for UCLA abutments, CoCr for castable abutments): "was shown to be biocompatible."
Sterilization according to ISO 11137-1 and 11137-2: "was conducted on the implants."
Abutment steam sterilization according to ISO 17665-1 and -2: "was done."
Material conformity to ASTM F136.
Endotoxin testing according to USP 161: "was conducted."

These are standard regulatory requirements for medical devices and do not relate to the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information for an AI/ML device, as the document does not discuss such a device or its associated studies.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 8, 2019

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

Re: K182615

Trade/Device Name: Surgikor Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 3, 2019 Received: April 9, 2019

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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

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,

for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental 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

510(k) Number (if known) K182615

Device Name Surgikor Dental Implant System

Indications for Use (Describe)

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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510k Summary K182615 July 8, 2019 Surgikor Dental Implant System

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 Dental Implant System Classification Name: Endosseous dental implants CFR: 21 CFR 872.3640 Primary Product Code: DZE Secondary Product Code: NHA

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:

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

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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.

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),

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regular and wide platform and hex connection regular platform. Wide emergence version are available in wide conical.

Standard Locator Abutments are supplied in shoulder heights of 1, 2, 3, 4, 5, and 6mm. Locators are intended for multiple unit restorations only.

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.

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. The 7mm implants are intended to be used in the molar region.

Testing Summary: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments are strong enough for their intended use. Surface cleanliness analysis of the implants was done and all tests were passed. The gold used for UCLA abutments was shown to be biocompatible. The CoCr used for castable abutments was shown to be biocompatible. Sterilization according to ISO 11137-1 and 11137-2 was conducted on the implants. Abutment steam sterilization was done according to ISO 17665-1 and -2. Materials used in the product meet ASTM F136. Endotoxin testing according to USP 161 was conducted.

Primary Predicate: Cortex Dental Implants K163385 Reference Devices: Cortex Dental Implants K090709 AB Dental Implants K132125 & K181381 and Osstem K161604

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Substantial Equivalence:

Surgikor's Dental Implant System is substantially equivalent to Cortex Dental Implants in indications for use, materials, design, and fatigue performance. Slight differences in implant and angled abutment design between the subject devices and the predicate devices were addressed by showing both had adequate fatigue performance. Larger size implants and abutments as well as some abutment designs needed a reference device. The Osstem reference devices are used for demonstrating equivalence in device design and size for larger implants and abutments. The Osstem wider implants also have the indications limitation for only use in the molar region. The Cortex reference device is used for demonstrating equivalence to some designs and sizes which are not present in the later Cortex predicate submission. The AB Dental Implants reference devices are used to demonstrate equivalence in abutments designs and heights which are not in the predicate device submission.

Company & Device Name	Surgikor's Dental Implant System	Cortex Dental Implants K090709 and K163385	AB Dental Implants K132125 & K181381	Osstem K161604
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	Cortex Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic device such as artificial teeth and to restore the patient's chewing function. The system is intended to be used in either single teeth or	A.BDENTAL DEVICES® Dental Implants 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. A.B. DENTAL DEVICES® Dental Implants	The Osstem Implant is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra Wide Fixture System is intended to be used in the molar region.

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achieved andwithappropriateocclusalloading. The7mm implantsare intendedto be used inthe molarregion.	multiple teethapplications.	System isindicated alsoforimmediateloading whengood primarystability isachieved andwithappropriateocclusalloading.'Two StageImplants:12,15,1661.One Stage:16, 16b,16B.OneStage & One-Piece 3.0 mmdiameterimplants: 16,168, 1681,are intendedfor placementatthemandibularcentral andlateralincisors andmaxillary andlateralincisors.Indicated alsofor denturestabilizationusing multipleimplants.One stage &One-Piece 2.4mm diameterimplants fortemporaryuse or longterm use: 16,16b, permitmmodinto
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			splint stabilityand long termfixation ofnew orexistingcrown, bridgeandprosthesis.P14AngulatedAbutmentAdapter is tobe used withimplantdiameter4.2mm andhigher.
ImplantDiameters	Versatile Hex3.5, 3.75, 4.2,4.5, 5.0,6.0mmImmediateHex 3.5,3.75,4.2, 4.5,5.0, 6.0,7.0mmFixationNarrowPlatform3.0mmFixationRegularPlatform 3.5,3.9mmFixation WidePlatform 4.3,5.0mmSolution5NarrowPlatform3.25mmSolution5Regular	Classix3.3, 3.8, 4.2, 5.0,6.0 Conical and HexDynamix3.0, 3.3, 3.8, 4.2,5.0, 6.0Conical and HexSaturn3.8, 4.2 HexMagix3.3, 3.8, 4.2 Conical		Osstem Hex 3.2, 3.5, 3.75,3.77, 4.2, 4.25, 4.4, 4.45,4.6, 4.63, 4.65, 4.8, 4.9,5.05, 5.08, 5.1, 5.25, 6.2,7.1 mm
	Platform 3.5,4.0mmSolution5Wide Platform4.5, 5.0, 5.5,6.0mmSolution23.25mm
ImplantLengths	Versatile Hex8, 10, 11.5, 13,16, 18 (4.2only), 20 (4.2only)mmImmediateHex 8 (no 3.5diameter) 10,11.5, 13,16mm 7.00diameter notin 11.5, 13 or16mm.FixationNarrowPlatform 10,11.5, 13,15mmFixationRegularPlatform 8.5,10, 11.5, 13,15, 18mmFixation WidePlatform 8.5,10, 11.5, 13,15, 18mmSolution5NarrowPlatform10,11.5, 13,15mmSolution5RegularPlatform 7.0	Classix 6,8,10,11.5,13, 16 no 3.3 or 3.8in 6, no 3.3 in 8, no5 in 16 and no 6 in13 or 16Dynamix6,8,10,11.5,13,16no 3.0 3.3 or 3.8 in6, no 3.3 or 3.8 in8, no 13 in 6 andno 5 or 6 in 16Saturn8,10,11.5,13,16Magix8,10,11.5,13 no 3.3in 8	Osstem6.2,7.0,8.5,10,11.5,13,15,18
	only), 8.5, 10,11.5, 13,15mmSolution5Wide Platform7.0, 8.5, 10,11.5, 13,15mm
	Solution2 10,11.5,13 16mm
Material ofdevicesincluded in thesubmission	Ti-6AL-4V ELI	Ti-6AL-4V ELI	Ti-6AL-4V ELI	Ti-6AL-4V ELI
Type of	Pre-manufacturedof no morethan 25°	Pre-manufacturedof no more than25°	Pre-manufacturedof no morethan 25	Pre-manufactured of nomore than 25
Interfacetype/shape	Internal hex,conical	Internal hex,conical	Internal hex	Internal hex
ISO 14801Fatigue Testing	Sufficient runout load fortheir intendeduse	Sufficient run outload for theirintended use	Sufficient runout load fortheirintended use	Sufficient run out load fortheir intended use
SurfaceTreatment	HA blasted anddouble acidetched	Alumina blastedand acid etched	HA blasted	Sand blasted and acidetched
Post SurfaceTreatmentCleanlinessDemonstrated	Yes	Yes	Yes	Yes

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Cover screw	Cover screw	Cover screw
Multi-UnitAbutments in HexRP and Conical(NP,RP,WP)	Multi-unitabutments inheights of 1,2,3 and4 mm in conicaldiameters of 3.0,3.5, and 4.3 plushex diameter of3.75	Straight Multi-unitAbutments inheights of 1,2,3,4and 5 mm
18° and 30 °AngledMulti-Unit	Multi-unitabutments inheights of 1,2,3 and	Angled Multi-UnitAbutments 18° and
Abutments inConical (NP, RP, WP)	4 mm in conicaldiameters of 3.0,3.5, and 4.3	30° in heights of1,2,34 and 5 mm
Locator Abutmentsin Hex RP	Locator abutmentsin heights of1,2,3,4,5,and 6mm	Low ProfileAbutments 5.5mmand 7mm in heightof 9mm	AB DentalK132125P25 AB Lock inheights of 0,1,2,3,4 and 5mm
Ball attachments inHex RP and ConicalNP,RP.WP	Ball attachments inheights of 1,2,3,4,5,and 6mm	Ball AttachmentSystem in heights of1,2,3,4,5,6 and 7mm
Healing Caps 4.5diameter standard	Conical healing capin 2,3,4,5,6 and7mm heightHex healing cap in2,3,4,5,6mm height	Healing CapAbutments 4.6mmin 2,3,4,5,6and 7mm
Healing Caps 5.5diameter wide	Conical healing capin 2,3,4,5,6 and7mm height	Healing CapAbutments in5.6mm in 2,3,4,5,and 6mm height
Healing Caps 3.75diameter narrow	Conical healing capin 2,3,4,5,6 and7mm height	Healing CapAbutments in3.8mm in2,3,4,5,6,and 7 mmheight
Healing Cap narrowemergence conicalWP and Hex RP	Narrow emergencehex and wideconical healing capin 2,3,4,5,6 and 7mm height		AB DentalK132125PON narrowemergencehealing cap in3,4,5,6 and7mm height
Healing Cap wideemergence conicalWP	Wide emergencewide conical healingcap in 2,3,4,5,6 and7 mm heightWide emergenceHex healing cap in2,3,4,5,6mm height			OsstemK161604Healing Cap forultra-widefixtures
Multi-Unit HealingCap	Single size healingcap for multi-unit	Single size healingcap for multi-unit
Standard TitaniumAbutment Hex RPConical RP and WP	Non-shoulderedStandard TitaniumAbutment withheights of 5,7, 9, 12,and 15 mm in Hex	Titanium abutmentsin 7.5 and 9mmheight	AB DentalImplantsK132125P3 and P3-5Hex Standard
	RP, Conical RP andWP		TitaniumAbutment withheight of 5,7,9,11,12,15mmP3C ConicalStandardTitaniumAbutmentheight of 9mm
Standard NarrowAbutment inConical NP	Non-shoulderedStandard narrowabutment withheights of 5,7,9 and12 mm in ConicalNP	Ttianium abutmentsin 7.5 and 9mmheight
Standard WideEmergenceAbutment inConical WP	Non-shoulderedstandard wideemergenceabutment withheights of 5,7,9,12,and 15mm			OsstemK161604Abutment forultra-widefixtures
Standard ShoulderAbutment	Standard shoulderabutment in heightsof 1,3 and 4mm	Straight Abutmentwith collar in heightsof 1,2,3 and 4mm
Standard WideShoulder Abutment	Standard WideShoulder Abutmentwith heights of1,2,3,and 4mm	Standard WideShoulder Abutmentwith heights of1,2,3,and 4mm
Standard 15°Abutment in HexRP and Conical NP,RP, WP	Standard 15°Abutment withlengths of9,11,13mm	Angulated 15°Abutment 9,12mm	AB DentalK132125Hex RP P4 15°Abutment withheight of8,9mmHex RP P4L 15°Abutmentheight of13.4mmConical RP 15°Abutment P4Cheight of 9mm
Standard 25°Abutment in HexRP and Conical RP,WP	Standard 25°Abutment withlengths of9,11,13mm	Angulated 25°Abutment 9,12mm	AB DentalK132125Hex RP P4 25°Abutment withheight of8,9mm
			Hex RP P4L 25°Abutmentheight of13.4mmConical RP 25°Abutment P4Cheight of 9mm
Narrow EmergenceStandard 15°Abutment in HexRP	Lengths of9,11,13mm	Angled 15°Abutment Slim 9mm	AB DentalK132125Hex RP P4N 15°NarrowAbutmentheight 9mm
Narrow EmergenceStandard 25°Abutment in HexRP	Lengths of9,11,13mm	Angled 25°Abutment Slim 9mm
Wide EmergenceStandard 15°Abutment inConical WP	Lengths of9,11,13mm		AB DentalK132125Hex RP P4ST15° Abutmentheight of 9mmP4-5 15°Abutmentheight of10.75, 11.1mm
Wide EmergenceStandard 25°Abutment inConical WP	Lengths of9,11,13mm		AB DentalK132125Hex RP P4ST25° Abutmentheight of 9mmP4-5 25°Abutmentheight of10.75, 11.1mm
AnatomicShoulderedStandard 15°AbutmentHex RP ConicalNP.RP and WP	Heights of 1,2, or3mm	Anatomic 15°AngulatedAbutment withcollarHeights of 1,2,3,4mm	AB DentalK132125Hex RP 15°ShoulderedAbutment ofheight 1,23mm overallheight of 7
AnatomicShoulderedStandard 25°	Heights of 1,2, or3mm	Anatomic AngulatedAbutment 25° withcollar

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Conclusion:

Surgikor Dental Implant System is substantially equivalent to Cortex Dental Implant System. They both have the same indications for use, are of the same material, and have internal hex or conical connections. The predicate device system does not have 7mm implants so does not have the indications statement about them being used in the molar region. The 7mm implants have indications limitation as the reference devices from Osstem which are wider implants. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Any abutment designs not found within the Cortex Dental Implant System were found in the reference devices which have the same materials, similar indications for use and same internal hex or conical connections as the Surgikor Dental Implant System. Performance testing demonstrates substantial equivalence to the identified predicate devices.

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.