The KJ Mini Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 2.0mm, 2.5mm, and 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The KJ Mini Implant System is intended for single use only. It is for delayed loading.

Device Description

KJ Mini Implant System is a dental implant system made of Titanium 6AL 4V ELI Gt.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the fixture part has been treated with R.B.M. The KJ Mini Implant System offers the following implants with various sizes.

AI/ML Overview

The document provided is a 510(k) premarket notification for the KJ Mini Implant System. It presents information to demonstrate substantial equivalence to predicate devices, rather than detailing a study focused on specific performance acceptance criteria for an AI or imaging device. Therefore, a direct answer to the request to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/imaging device performance cannot be fully provided from the given text.

The document discusses non-clinical testing for the dental implant system itself, which primarily focuses on manufacturing and material standards rather than diagnostic performance metrics.

Below is an attempt to structure an answer based on the available information, highlighting what is not present in the document.

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) that would be typical for an AI-powered diagnostic device. Instead, it compares the new device (KJ Mini Implant System) to predicate devices based on design, materials, indications for use, and technological characteristics to demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not available in the provided document. The document describes non-clinical testing for sterilization and shelf-life, which are laboratory tests, not clinical studies with test sets of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not available in the provided document. As the device is a dental implant, not an AI/imaging diagnostic tool, the concept of "ground truth for a test set" established by experts in the context of diagnostic performance metrics does not apply to the information presented.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not available in the provided document. Adjudication methods are relevant for clinical studies assessing diagnostic accuracy, which are not detailed here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not available in the provided document. The device is a dental implant, not an AI-assisted diagnostic tool, so MRMC studies or human-in-the-loop performance metrics are not applicable to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not available in the provided document. The device is a dental implant, and therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not available in the provided document. The concept of ground truth in the context of diagnostic accuracy is not discussed. For a dental implant, "ground truth" would more likely refer to successful integration, absence of complications, or restoration of masticatory function, which would be assessed in clinical trials. However, the provided document focuses on premarket notification for substantial equivalence based on material and physical characteristics.

8. The sample size for the training set

This information is not available in the provided document. Training sets are applicable to machine learning algorithms, which are not part of this dental implant device.

9. How the ground truth for the training set was established

This information is not available in the provided document, for the same reasons as #8.

Summary of Non-Clinical Testing (from the document):

The provided document describes the following non-clinical tests for the KJ Mini Implant System to demonstrate safety and effectiveness for its intended use, focusing on material and physical properties, not diagnostic performance:

Sterilization Validation Testing:
- According to ISO 11137-1 & ISO 11137-2 for implants (gamma sterilization).
- According to ISO 17665-1 & ISO 17665-2 for abutments.
Three-year shelf-life testing: According to ASTM F1980.
Chemical and SEM Analysis: (Details not provided in the summary).

The document concludes that based on the similarities in intended use, operating principle, basic design, material, and surface treatment to predicate devices, the KJ Mini Implant System is substantially equivalent. This implies that if the predicate devices meet performance and safety criteria, the new device, being substantially equivalent, would also meet them. However, specific acceptance criteria for these tests and their detailed results are not explicitly enumerated in this 510(k) summary.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 21, 2016

KJ Meditech Co., Ltd. c/o Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton. California 92831

Re: K151970

Trade/Device Name: KJ Mini Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 22, 2016 Received: September 22, 2016

Dear Priscilla Chung:

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. 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K151970

Device Name

KJ Mini Implant Sy stem

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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510(k) Summary

This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 10/20/2016

1. Applicant / Submitter

	Submitter
Name	KJ Meditech Co., Ltd.
Address	959-21 Daechon-dong, Buk-gu,Gwang-ju, 500-470,South Korea
Phone	+82-62-972-5476
Fax	+82-62-973-2809
Contact	Huykki Moon, CEO

2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

Trade Name: KJ Mini Implant System
. Common Name: Dental Implant System
Classification Name: Endosseous Dental Implant
Product Code: DZE, NHA
Classification regulation: 21CFR872.3640

4. Predicate Device:

Primary Predicate Device: One Plus Implant System by OsseoFuse Co., Ltd. (K133050)
. Reference Predicate Device: MS System by OSSTEM Implant Co., Ltd. (K083067)

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Spectra System by Implant Direct LLC (K061319) Intra-Lock Dental Implant System with Blossom by Intra-Lock International Inc. (K103194) MILO Dental Implant System by Intra-Lock International Inc. (K050970) MS System(Denture) by OSSTEM Implant Co., Ltd. (K072959)

5. Device Description:

	OneBody Implant	Post Implant	Ball Implant
ImplantDiameters	2.50mm, 2.80mm,3.00mm, 3.30mm,3.50mm, 3.80mm,4.00mm, 4.30mm,4.50mm, 4.80mm,5.00mm, 5.30mm	3.50mm, 4.00mm,4.50mm, 5.00mm	2.00mm, 2.50mm,3.00mm, 3.50mm,4.00mm, 4.50mm,5.00mm
ImplantLengths	• (for 2.50mm-3.00mmDia.) 10mm, 11mm,12mm, 13mm, 14mm,15mm• (for 3.30mm to5.30mm Dia.) 10mm,11mm, 12mm, 13mm,14mm,15mm, 16mm	10mm, 11mm, 12mm,13mm, 14mm, 15mm,16 mm	• (for 2mm to 3mm):10mm,11mm, 12mm, 13mm,14mm, 15mm• (for 3.5mm to 5mm):10mm, 11mm,12mm,13mm, 14mm, 15mm,16mm

Post Abutment is offered for Post Implant and it offers straight type only. Ball Attachment is offered for Ball Implant. Both Post Abutment and Ball Attachments are made of Ti 6Al 4V ELI, Gr.23.

All the implant types of the KJ Mini Implant System are straight only.

6. Indication for use:

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7. Basis for Substantial Equivalence

The KJ Mini Implant System has the same intentified predicate devices. They are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium.

The subject and predicate devices are similar in design, size, materials, and are sterilized via gamma irradiation for fixtures.

	Subject Device	Primary Predicate Device	Reference Predicate Device	Reference Predicate Device3
510(K) Number	K151970	K133050	K083067	K061319
Device Name	KJ Mini Implant System	One Plus Implant System	MS System	Spectra System(One Piece Implants)
Applicant	KJ Meditech Co., Ltd.	OsseoFuse Co., Ltd.	OSSTEM Implant Co., Ltd.	Implant Direct LLC
Contract Manufacturer	KJ Meditech Co., Ltd.	KJ Meditech Co., Ltd.
Indications for Use	The KJ Mini Implant System isintended to use in the treatmentof missing teeth to supportprosthetic device, such asartificial teeth, in order torestore mastication in partiallyedentulous patients. 2.0mm,2.5mm, and 3.0mm diameterimplants are intended to beused in central or lateralmandibular incisors. The KJMini Implant System isintended for single use only. Itis for delayed loading.	The One Plus Implant Systemis intended to use in thetreatment of missing teeth tosupportprosthetic device, such asartificial teeth, in order torestore mastication in partiallyedentulous patients. 3.0mmdiameter implants are intendedto be used in central or lateralmandibular incisors. The OnePlus Implant System isintended for single use only. Itis for delayed loading.	The MS System (NarrowRidge) is intended to use in thetreatment of missingmandibular central and lateralincisors to support prostheticdevice, such as artificial teeth,in order to restore chewingfunction in partially edentulouspatients. MS System (NarrowRidge) is intended for singleuseonly. It is not for immediateloading.	The Spectra Dental ImplantSystem consists of one-piece ortwo-piece implants for single-stage or two stage surgicalprocedures that are intended foruse in partially or fullyedentulous mandibles andmaxillae, in support of single ormultiple-unit restorations andterminal or intermediateabutment support for fixedbridgework. They may beplaced in immediate function ifinitial implant stability can beestablished.The ScrewDirect 3.0mmimplant is indicated for:1. An artificial root structure forsingle tooth replacement ofmandibular central and lateralincisors

7.1. OneBody Implant

510(k) Submission.

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				and maxillary lateral incisors.
Technological characteristics	Implant Type: One Piece Type RBM Treatment on the fixture body Body Design: Threaded body	Implant Type: One Piece Type RBM Treatment on the fixture body Body Design: Threaded body	Implant Type: One Piece Type RBM Treatment on the fixture body Body Design: Threaded body	Threaded, root form implant Tapered threaded body with an integrated abutment Self-tapping
Principles of Operation	One piece type which a fixture and an abutment are integrated.	One piece type which a fixtu re and an abutment are integ rated.	One piece type which a fixtu re and an abutment are integ rated.	One piece type which a fixture and an abutment are integrated.
Appearance	Image: Implant	Image: Implant	Image: Implant	Image: Implant
Material	Ti 6A1 4V ELI, Gr.23	Ti 6A1 4V ELI, Gr.23	Ti 6A1 4V ELI, Gr.23	Titanium Alloy
Surface Treatment	RBM Treatment on the fixture body	RBM Treatment on the fixture bodyTiN coating on the abutment	RBM Treatment on the fixture body	RBM Treatment on the fixture body
Implant Sterile	Yes	Yes	Yes	Yes
Sterilization Method	Gamma	Gamma	Gamma	Gamma
Restoration type	Single unit, Multi unit	Single Unit, Multi unit	Single Unit, Multi unit	Single Unit, Multi unit
Implant Diameters	2.50mm, 2.80mm, 3.00mm,3.30mm, 3.50mm, 3.80mm,4.00mm, 4.30mm, 4.50mm,4.80mm, 5.00mm, 5.30mm	3.00mm, 3.75mm, 4.50mm,5.25mm	2.50mm 3.00mm	3.0mm, 3.7mm, 4.7mm, 5.7 mm
Implant Lengths	(for 2.50mm-3.00mm Dia.)10mm-15mm	11.5mm, 13mm, 14.5mm	10.0 mm, 13.0mm, 15.0mm	10mm, 13mm, 16mm
	• (for 3.30mm to 5.30mmDia.) 10mm-16mm
Product Code	DZE	DZE	DZE	DZE

510(k) Submission.

510(k) summary , 4 / 10 page

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Substantial Equivalence Discussion

The subject device is substantially equivalent to the noted on tabulated device specifications and properties presented. Based on the comparison analysis, similar intended use, comparable technological characteristics, and similar general design features, the subject device is substantially equivalent to the predicate differences between the KJ Mini Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to the predicate devices in design, function, material and intended use.

7.2. Post Implant

	Subject Device	Predicate Device1	Predicate Device2
510(K) Number	K151970	K103194	K050970
Device Name	KJ Mini Implant System	Intra-Lock Dental Implant System withBlossom	MILO Dental Implant System
Manufacturer	KJMEDITECH Co., Ltd.	Intra-Lock International Inc.	Intra-Lock International Inc.
Indications for Use	The KJ Mini Implant System isintended to use in the treatment ofmissing teeth to support prostheticdevice, such as artificial teeth, inorder to restore mastication inpartially edentulous patients. 2.0mm,2.5mm, and 3.0mm diameterimplants are intended to be used incentral or lateral mandibular incisors.The KJ Mini Implant System isintended for single use only. It is fordelayed loading.	The Intra-lock Dental Implant systemhas been designed to restore partiallyor fully edentulous patients. TheImplant have been designed to be usedin either the mandible or the maxillaand to support removable or fixedprosthesis from Single toothreplacement to full arch reconstruction.They are intended for immediatefunction on single and/or multiple toothapplications when good primarystability is achieved, with appropriateocclusal loading, in order to restore	MILO Implants are indicated forlong-term maxillary and mandibulartissue-supported denturestabilization. Multiple implants maybe restored after a period of time orplaced in immediate function.
		normal teeth functions
Technologicalcharacteristics	• Implant Type: Mini Implant Type• Neck Design: Straight walled neck• RBM Treatment on the fixturebody• Body Design: Threaded body	• Implant Type: Mini Implant Type• Neck Design: Straight walled neck• Body Design: Threaded body	• Implant Type: Mini Implant Type• Neck Design: Straight walled neck• Body Design: Threaded body
Principles ofOperation	Fix the abutment to the implant byfriction	Fix the abutment to the implant byfriction	Fix the abutment to the implant byfriction
Appearance	Image: Three implants	Image: An implant	Image: Two implants
Material	Ti 6Al 4V ELI, Gr.23	Ti 6Al 4V ELI, Gr.23	Ti 6Al 4V ELI, Gr.23
Surface Treatment	RBM Treatment on the fixture body	RBM Treatment on the fixture body	RBM Treatment on the fixture body
Implant Sterile	Yes	Yes	Yes
Sterilization Method	Gamma	Gamma	Gamma
Restoration type	Single unit, Multi unit	Single Unit, Multi unit	Single Unit, Multi unit
Implant Diameters	3.50mm, 4.00mm, 4.50mm, 5.00mm	3.4mm, 4.0mm, 6.0mm	3.0mm
Implant Lengths	10 - 16 mm	10mm~18mm	10mm~15mm

510(k) Submission.

510(k) summary , 5 / 10 page

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510(k) Submission.

510(k) summary , 6 / 10 page

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Abutment Appearance		9mm	7.3mm
Abutment Total Length	9.0mm~9.5mm	7.3mm ~ 10mm	7.3mm ~ 10mm
Abutment Material	Ti 6Al 4V ELI, Gr.23	Ti 6Al 4V ELI, Gr.23	Ti 6Al 4V ELI, Gr.23
Abutment Surface Treatment	None	None	None
Abutment Type	Straight	Straight, Angled	Straight, Angled

Substantial Equivalence Discussion

The subject device is substantially equivate to the noted predicate devices specifications and properties presented. Based on the comparison analysis, similar intended use, comparable technological characteristics, and similar general design features, the subject device is substantially equivalent to the predicate devices. There are no significant differences between the KJ Mini Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to the predicate devices in design, function, material and intended use.

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7.3. Ball Implant

	Subject Device	Predicate Device	Predicate Device	Predicate Device
510(K) Number	K151970	K072959	K103194	K050970
Device Name	KJ Mini Implant System	MS System(Denture)	Intra-Lock Dental ImplantSystem with Blossom	MILO Dental Implant System
Manufacturer	KJ Meditech Co., Ltd.	OSSTEM Implant Co., Ltd.	Intra-Lock International Inc.	Intra-Lock International Inc.
Indications for Use	The KJ Mini Implant System isintended to use in the treatmentof missing teeth to supportprosthetic device, such asartificial teeth, in order torestore mastication in partiallyedentulous patients. 2.0mm,2.5mm, and 3.0mm diameterimplants are intended to beused in central or lateralmandibular incisors. The KJMini Implant System isintended for single use only. Itis for delayed loading.	The MS System (Denture) isintended to be place in the boneof the upper or lower jawarches to provide support theprosthetic devices to restore thepatient'schewing function, including thedenture stabilization. MSSystem (Denture) isintended for single use only.	The Intra-lock Dental Implantsystem has been designed torestore partially or fullyedentulous patients. TheImplant have been designed tobe used in either the mandibleor the maxilla and to supportremovable or fixed prosthesisfrom Single tooth replacementto full arch reconstruction.They are intended forimmediate function on singleand/or multiple toothapplications when goodprimary stability is achieved,with appropriate occlusalloading, in order to restorenormal teeth functions	MILO Implants are indicatedfor long-term maxillary andmandibular tissue-supporteddenture stabilization. Multipleimplants may be restored aftera period of time or placed inimmediate function.
Design	• Implant Type: Ball ShapeHead Implant Type• RBM Treatment on thefixture body• Body Design: Threaded body	• Implant Type: Ball ShapeHead Implant Type• RBM Treatment on thefixture body• Body Design: Threaded body	• Implant Type: Mini ImplantType• Neck Design: Straight walledneck• Body Design: Threaded body	• Implant Type: Mini ImplantType• Neck Design: Straight walledneck• Body Design: Threaded body
Principles of Operation	Ball shaped implant headallowing for the retainingstructures to snap over the ball	Ball shaped implant head allowing for the retaining structures to snap over the ball	Ball shaped implant headallowing for the retainingstructures to snap over the ball	Ball shaped implant headallowing for the retainingstructures to snap over the ball

510(k) Submission.

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Appearance	Image: Implant	Image: Implant	Image: Implant	Image: Implant
Material	Ti 6Al 4V ELI, Gr.23	Ti 6Al 4V ELI, Gr.23	Ti 6Al 4V ELI, Gr.23	Ti 6Al 4V ELI, Gr.23
Surface Treatment	RBM Treatment on the fixturebody	RBM Treatment on the fixturebody	RBM Treatment on the fixturebody	RBM Treatment on the fixturebody
Implant Sterile	Yes	Yes	Yes	Yes
Sterilization Method	Gamma	Gamma	Gamma	Gamma
Restoration type	Overdenture	Overdenture	Overdenture	Overdenture
Implant Diameters	2.00mm, 2.50mm, 3.00mm,3.50mm, 4.00mm, 4.50mm,5.00mm	2.00mm 3.00mm	3.4mm, 4.0mm, 6.0mm	3.0mm
Implant Lengths	(for 2mm to 3mm): 10-15mm(for 3.5mm to 5mm): 10-16mm	10.0 mm, 13.0mm, 15.0mm	10mm~18mm	10mm~15mm
Attachment	Image: Attachment	Image: Attachment	Image: Attachment	Image: Attachment

Substantial Equivalence Discussion

The subject device is substantially equivate devices based on tabulated device specifications and properties presented. Based on the comparison analysis, similar intended use, comparable technological characteristics, and similar general design features, the subject device is substantially equivalent to the predicate differences between the KJ Mini Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to the predicate devices in design, function, material and intended use.

510(k) Submission.

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8. Non-Clinical Testing

Sterilization validating testing ●
- o according to ISO 11137-1 & ISO 11137-2 for implants
- o according to ISO 17665-1 & ISO 17665-2 for abutments
Three year shelf life testing according to ASTM F1980
Chemical and SEM Analysis

9. Conclusion

The subject devices and the predicate device have the same intended use and have the same technological characteristics.

Overall, the KJ Mini Implant System has the following similarities to the predicate device:

- have the same intended use,
- use the same operating principle,
- incorporate the same basic design,
- incorporate the same material and the surface treatment

Based on the similarities, we conclude that the KJ Mini Implant System is substantially equivalent to the 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.