The Kisses Mini is indicated for use in partially or fully edentulous maxilla, in support of single or multiple-unt restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Kisses Mini is for single and two stage surgical procedures. It is for delayed loading.

The intended use of the 3.2 mm Internal Hex fixtures is limited to the replacement of maxillary lateral incisors.

The intended use of the single-piece post type fixture to replacement of mandibular central and lateral incisors.

The ball-type single-piece implant is intended for stabilization and retention of overdentures.

Device Description

KJ Mini offers three different types of implants: 2-Piece Type, Post Type, and Ball Type.

The 2-piece type fixture is a substructure of a dental implant system to replace a single tooth, and the lost root of edentulous patients. It consists of the hex part to be coupled to the superstructure, the single thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers single hex type and double hex type.

The post type fixture is a substructure of a dental implant system to replace a single tooth, and the lost root of edentulous patients.

The ball type fixture is a substructure of a dental implant system to replace a single tooth, and the lost root of edentulous patients.

AI/ML Overview

The document is a 510(k) Summary for the "Kisses Mini" dental implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a traditional clinical study with outcome metrics.

Therefore, the requested information elements (acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, type of ground truth) related to a clinical study or AI model evaluation are not applicable in this context, as this is a regulatory submission for a medical device based on showing equivalence to existing devices.

The document discusses non-clinical testing to support substantial equivalence and safety/performance.

Here's a summary of the non-clinical testing performed as described in the document (Section 8):

1. Table of Acceptance Criteria and Reported Device Performance (as related to non-clinical testing for equivalence):

Test Performed	Acceptance Criteria (Implied/Standard)	Reported Device Performance
Sterilization (Gamma, Steam)	ISO 11137, ISO 17665-1, ISO 17665-2 compliance	Performed in accordance with standards
Shelf Life (Accelerated Testing)	3 years validated	3 years validated
Fixture Surface Characteristics (SLA treatment)	Similar to predicate / acceptable for intended use	Evaluated through Surface Morphology, Surface Roughness Analysis, and FT-IR Analysis; "test results support it does not affect substantial equivalence"
Performance Tests (Visual inspection, Dimension, Packing inspection, Sterility, Adaption accuracy, Marginal adaptation, Compressive strength, Fatigue, Rotational shear strength, Screw loosening torque tests)	Appropriate for dental implants / comparable to predicates	"Other Performance tests" (implies successful completion)
Endotoxin Testing (USP <85>)	Below 0.5 EU/mL	"Will be conducted on every batch," "referenced USP 39 <85> Bacterial Endotoxin Test on the endotoxin limit which is 0.5 EU/mL"
Fatigue Test (for Angled Abutment)	Supported substantial equivalence	"Test result of the fatigue test supported substantial equivalence"

2. Sample size used for the test set and data provenance:

Not applicable for a clinical study as described. The testing refers to non-clinical (laboratory/bench) tests. Specific sample sizes for each non-clinical test are not provided in this summary, but generalized statements about the tests being performed are made. Data provenance is implied to be from the manufacturer's internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No expert ground truth establishment for a clinical test set is mentioned.

4. Adjudication method for the test set:

Not applicable. No clinical test set or adjudication is mentioned.

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:

Not applicable. This document is for a physical dental implant, not an AI-powered diagnostic or assistive device.

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

Not applicable. This document is for a physical dental implant, not an algorithm.

7. The type of ground truth used:

Not applicable for a clinical study. For non-clinical tests, physical and chemical standards (e.g., ISO for sterilization, USP for endotoxin) serve as the "ground truth" or reference for performance. Specific product specifications and predicate device characteristics also serve as comparators for "ground truth" for substantial equivalence.

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning model or a training set.

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

Not applicable. This document does not describe a machine learning model or a training set.

In summary: This 510(k) summary is a regulatory submission for a physical medical device (dental implants) and demonstrates substantial equivalence through comparisons to predicate devices and non-clinical bench testing. It does not involve AI, clinical trials with human subjects for performance evaluation (beyond what's typically implicit in dental implant use), or the associated concepts of acceptance criteria tables, sample sizes, expert ground truth, or MRMC studies that would be relevant for an AI/CAD product.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 6, 2017

ACHIMHAI Medical Corporation % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt. Suite 417 Irvine, California 92620

Re: K170394

Trade/Device Name: Kisses Mini Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 4, 2017 Received: September 7, 2017

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.

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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); good manufacturing practice requirements as set forth in 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,

Andrew I. Steen -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) K170394

Device Name Kisses Mini

Indications for Use (Describe)

The intended use of the 3.2 mm Internal Hex fixtures is limited to the replacement of maxillary lateral incisors.

The intended use of the single-piece post type fixture to replacement of mandibular central and lateral incisors.

The ball-type single-piece implant is intended for stabilization and retention of overdentures.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

(K170394)

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

Date: 10/06/2017

1. Submitter

ACHIMHAI Medical Corporation 28, Namyang-ro, 930beon-gil, Namyang-eup Hwaseong-si, Gyeonggido, Republic of Korea, 18255

2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine CA 92620 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

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

4. Predicate Device:

. Primary Predicate Device: MiNi Internal Implant System (K150537) by MegaGen Implant Co., Ltd. S-MiNi Implant System (K112540) by Neobiotech Co., Ltd.
Reference Predicate Device: ● Biogenesis Implant System – Kisses (K142813) by Achimhai Medical Corporation

5. Description:

KJ Mini offers three different types of implants: 2-Piece Type, Post Type, and Ball Type.

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3.2mm Dia. x 8mm L ●
3.2mm Dia. x 9.5mm L ●
3.2mm Dia. x 11mm L
3.2mm Dia. x 12.5mm L
3.2mm Dia. x 14.5mm L

The post type fixture is a substructure of a dental implant system to replace a single tooth, and the lost root of edentulous patients.

2.8mm Dia. x 8mm L ●
2.8mm Dia. x 9.5mm L ●
2.8mm Dia. x 11mm L ●
2.8mm Dia. x 12.5mm L ●
2.8mm Dia. x 14.5mm L
3mm Dia. x 8mm L
3mm Dia. x 9.5mm L
3mm Dia. x 11mm L
3mm Dia. x 12.5mm L
3mm Dia. x 14.5mm L .

The ball type fixture is a substructure of a dental implant system to replace a single tooth, and the lost root of edentulous patients.

2.8mm Dia. x 8mm L ●
2.8mm Dia. x 9.5mm L ●
2.8mm Dia. x 11mm L ●
2.8mm Dia. x 12.5mm L ●
2.8mm Dia. x 14.5mm L
. 3mm Dia. x 8mm L
. 3mm Dia. x 9.5mm L
3mm Dia. x 11mm L ●
3mm Dia. x 12.5mm L .
3mm Dia. x 14.5mm L ●

6. Indication for use:

The Kisses Mini is indicated for use in partially or fully edentulous mandibles and maxilla, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Kisses Mini is for single and two stage surgical procedures. It is for delayed loading.

The intended use of the 3.2 mm Internal Hex fixtures is limited to the replacement of

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maxillary lateral incisors and mandibular incisors.

The intended use of the single-piece post type fixture is limited to replacement of mandibular central and lateral incisors.

The ball-type single-piece implant is intended for stabilization and retention of overdentures.

7. Basis for Substantial Equivalence

7.1. Fixture

Internal Hex Type

	Subject Device	Primary Predicate Device	Reference Predicate Device
510(K) Number	-	K150537	K142813
Device Name	Kisses Mini	MiNi Internal Implant System	Biogenesis Implant System -Kisses
Manufacturer	Achimhai Medical Corporation	MegaGen Implant Co., Ltd.	Achimhai Medical Corporation(Note: Our company namehas changed from Biogenesisto Achimhai.)
Type	Internal hex	Internal hex	Internal hex
Design & Size Range	Diameter: 3.2 mmLength: 8 - 14.5 mm	Diameter: 3.0 – 3.4 mmLength: 8-14.5 mm	Diameter: 3.5 - 5.5 mmLength: 7-15 mm
Indications for Use	The Kisses Mini is indicatedfor use in partially or fullyedentulous mandibles andmaxilla, in support of single ormultiple-unit restorationsincluding; cemented retained,screw retained, oroverdenture restorations, andterminal or intermediateabutment support for fixedbridgework. The Kisses Miniis for single and two stagesurgical procedures. It is fordelayed loading.The intended use of the 3.2mm Internal Hex fixtures islimited to the replacement ofmaxillary lateral incisors andmandibular incisors.The intended use of thesingle-piece post type fixtureis limited to replacement ofmandibular central and lateralincisors.	The MiNi Internal ImplantSystem is intended for twostage surgical procedures inthe following situations andwith the following clinicalprotocols:• The intended use for the 3.0mm diameter MiNi implant islimited to the replacement ofmaxillary lateral incisors andmandibular incisors.• Immediate placement inextraction sites and insituations with a partially orcompletely healed alveolarridge.• It is intended for delayedloading.	The Biogenesis ImplantSystem -Kisses is indicatedfor use in partially or fullyedentulous mandibles andmaxillae, in support of singleor multiple-unit restorationsincluding; cemented retained,screw retained, oroverdenture restorations, andterminal or intermediateabutment support for fixedbridgework.The Biogenesis ImplantSystem - Kisses is for singleand two stage surgicalprocedures. It is for delayedloading.

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	The ball-type single-pieceimplant is intended forstabilization and retention ofoverdentures.
Principle ofOperation	The device is a substructureof a dental implant system toreplace a single tooth and thelost root of edentulouspatients. It consists of the hexpart to be coupled to thesuperstructure, the singlethread part to be fixed to thebone, and the cutting edgepart with the self-tappingfunction.	The device is a substructureof a dental implant system toreplace a single tooth and thelost root of edentulouspatients. It consists of the hexpart to be coupled to thesuperstructure, the singlethread part to be fixed to thebone, and the cutting edgepart with the self-tappingfunction.	The device is a substructureof a dental implant system toreplace a single tooth and thelost root of edentulouspatients. It consists of the hexpart to be coupled to thesuperstructure, the singlethread part to be fixed to thebone, and the cutting edgepart with the self-tappingfunction.
Material Composition	Ti Gr.4	Ti Gr.4	Ti Gr.4
Surface Treatment	SLA Treatment	SLA Treatment	SLA Treatment
Sterile	Yes	Yes	Yes
Sterilization Method	Gamma	Gamma	Gamma

Kisses Mini Internal hex type fixture is substantially equivalent to the predicate devices in terms of intended use and technical characteristics. They have similar design that all the devices are two piece type fixtures with thread part to be fixed to the bone. They are made of the same material and all have cutting edge part for self-tapping function. The size range of the primary predicate device encompasses the size range of the subject device.

There are slight differences in design such as thread sizes but it is very minor not affecting the substantial equivalence. Also, the Kisses Mini indications for use differ from the predicate devices in some languages for specific types and size, however, these differences do not raise new concerns because limiting the use of each type is a more conservative surgical approach.

Post Type

	Subject Device	Primary Predicate Device
510(K) Number	N / A	K112540
Device Name	Kisses Mini	S-MiNi Implant System
Manufacturer	Achimhai Medical Corporation	Neobiotech Co., Ltd.
Type	Post	Post
Design & Size Range	Image: A dental implant.Diameter: 2.8 - 3.0 mmLength: 8 - 14.5 mmCuff: 2.5 – 4.0 mmPost: 8.0 mm	Image: A dental implant.Diameter: 2.0 – 3.5 mmLength: 7-15 mmCuff: 2.0 mmPost: 10.0 mm
Intended Use	The Kisses Mini is indicated for use in partiallyor fully edentulous mandibles and maxilla, insupport of single or multiple-unit restorationsincluding; cemented retained, screw retained,or overdenture restorations, and terminal or	The S-MiNi Implant System is intended to usein the treatment of missing mandibular centraland lateral incisors to support prostheticdevice, such as artificial teeth, in order torestore chewing function partially edentulous.

510(k) Submission

{8}------------------------------------------------

intermediate abutment support for fixedbridgework. The Kisses Mini is for single andtwo stage surgical procedures. It is fordelayed loading.The intended use of the 3.2 mm Internal Hexfixtures is limited to the replacement ofmaxillary lateral incisors and mandibularincisors.The intended use of the single-piece post typefixture is limited to replacement of mandibularcentral and lateral incisors.The ball-type single-piece implant is intendedfor stabilization and retention of overdentures.
Principle ofOperation	The device is a substructure of a dentalimplant system to replace a single tooth andthe lost root of edentulous patients. It consistsof the single thread part and the post part; thesingle thread part to be fixed to the bone, andthe cutting edge part with the self-tappingfunction.	The device is a substructure of a dentalimplant system to replace a single tooth andthe lost root of edentulous patients. It consistsof the single thread part and the post part; thesingle thread part to be fixed to the bone, andthe cutting edge part with the self-tappingfunction.
Material Composition	Ti Gr.4	Ti Gr.4
Surface Treatment	SLA Treatment	RBM Treatment
Sterile	Yes	Yes
Sterilization Method	Gamma	Gamma

Kisses Mini Post type Implant is substantially equivalent to the predicate devices in terms of intended use and technical characteristics. The design is very similar that the both devices are one body type which a fixture and an abutment are combined. They are material and all have cutting edge part for self-tapping function. The size range of the predicate device encompasses the size range of the subject device.

The difference is in cuff size that the subject device cuff is longer than the predicate device. However, this difference does not affect substantial equivalence.

Another difference is in surface treatment that the subject device employs SLA and the predicate device employs RBM. For the subject deice, surface morphology, surface roughness Analysis, and FT-IR Analysis were performed to evaluate its characteristics, and the test results support it does not affect substantial equivalence.

Also, the Kisses Mini indications for use differ from the predicate devices in some languages for specific types and size, however, these differences do not raise new concerns because limiting the use of each type is a more conservative surgical approach.

Ball Type

	Subject Device	Primary Predicate Device
510(K) Number	N / A	K112540
Device Name	Kisses Mini	S-MiNi Implant System
Manufacturer	Achimhai Medical Corporation	Neobiotech Co., Ltd.
Type	Ball	Ball

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Design & Size Range
Image: Implant	Image: Implant
Diameter: 2.8 – 3.0 mmLength: 8 - 14.5 mmCuff: 2.0-4.0 mm	Diameter: 2.0 – 3.5 mmLength: 7 - 15 mmCuff: 3.0-4.0 mm
Intended Use
The Kisses Mini is indicated for use inpartially or fully edentulous mandibles andmaxilla, in support of single or multiple-unitrestorations including; cemented retained,screw retained, or overdenture restorations,and terminal or intermediate abutmentsupport for fixed bridgework. The Kisses Miniis for single and two stage surgicalprocedures. It is for delayed loading.The intended use of the 3.2 mm Internal Hexfixtures is limited to the replacement ofmaxillary lateral incisors and mandibularincisors.The intended use of the single-piece posttype fixture is limited to replacement ofmandibular central and lateral incisors.The ball-type single-piece implant is intendedfor stabilization and retention of overdentures.	The S-MiNi Implant System is intended to beplace in the bone of the upper or lower jawarches to provide support the prostheticdevices to restore the patient's chewingfunction, including the denture stabilization.S-MiNi Implant System is intended for singleuse only
Principle of Operation
The device is a substructure of a dentalimplant system to replace a single tooth andthe lost root of edentulous patients. It consistsof the single thread part and the ball part; thesingle thread part to be fixed to the bone, thecutting edge part with the self-tappingfunction, and the ball part for detachabledenture.	The device is a substructure of a dentalimplant system to replace a single tooth andthe lost root of edentulous patients. It consistsof the single thread part and the ball part; thesingle thread part to be fixed to the bone, thecutting edge part with the self-tappingfunction, and the ball part for detachabledenture.
Material Composition
Ti Gr.4	Ti Gr.4
Surface Treatment
SLA Treatment	RBM Treatment
Sterile
Yes	Yes
Sterilization Method
Gamma	Gamma

Kisses Mini Ball type Implant is substantially equivalent to the predicate devices in terms of intended use and technical characteristics. The design is also similar that the both devices have a ball-type structure for the connection of the O-ring attachment. They are made of the same material and all have cutting edge part for self-tapping function. The size range of the predicate device encompasses the size range of the subject device.

There is slight difference in design such as cuff design but it is very minor not affecting substantial equivalence.

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7.2. Abutment

	Subject Device	Primary Predicate Device	Reference Predicate Device
510(K) Number		K150537	K142813
Device Name	Kisses Mini	MiNi Internal Implant System	Biogenesis Implant System -Kisses
Manufacturer	Achimhai MedicalCorporation	MegaGen Implant Co., Ltd.	Achimhai Medical Corporation(Note: Our company namehas changed from Biogenesisto Achimhai.)
Type	Internal	Internal	Internal hex
Indications for Use	The Kisses Mini is indicatedfor use in partially or fullyedentulous mandibles andmaxilla, in support of singleor multiple-unit restorationsincluding; cementedretained, screw retained, oroverdenture restorations,and terminal or intermediateabutment support for fixedbridgework. The Kisses Miniis for single and two stagesurgical procedures. It is fordelayed loading.The intended use of the 3.2mm Internal Hex fixtures islimited to the replacementof maxillary lateral incisorsand mandibular incisors.The intended use of thesingle-piece post typefixture is limited toreplacement of mandibularcentral and lateral incisors.The ball-type single-pieceimplant is intended forstabilization and retention ofoverdentures.	The MiNi Internal ImplantSystem is intended for twostage surgical procedures inthe following situations andwith the following clinicalprotocols:· The intended use for the 3.0mm diameter MiNi implant islimited to the replacement ofmaxillary lateral incisors andmandibular incisors.· Immediate placement inextraction sites and insituations with a partially orcompletely healed alveolarridge.• It is intended for delayedloading.	The Biogenesis ImplantSystem -Kisses is indicatedfor use in partially or fullyedentulous mandibles andmaxillae, in support of singleor multiple-unit restorationsincluding; cemented retained,screw retained, oroverdenture restorations, andterminal or intermediateabutment support for fixedbridgework.The Biogenesis ImplantSystem - Kisses is for singleand two stage surgicalprocedures. It is for delayedloading.
Principle of Operation	The abutments are to becoupled to the fixtures tomake temporary or finalprosthesis.	The abutments are to becoupled to the fixtures tomake temporary or finalprosthesis.	The abutments are to becoupled to the fixtures tomake temporary or finalprosthesis.
Abutment 1- Duplex Abutment

Design & Size Range	HexDiameter: 3.5mmPost Height : 5.5mm-7.0mmGingival Height: 1mm -4.5mm	HexDiameter: 3.5mmPost Height : 5.0mm-9.0mmGingival Height: 1mm -4.5mm	Hex & Non-HexDiameter: 4.5mm - 6.5mmPost Height : 5.5mmGingival Height: 1mm -5.5mm
Intended Use	Cement retained restoration	Cement retained restoration	Cement retained restoration
Material Composition	Ti Gr.4	Ti Gr.4	Ti Gr.4
Surface Treatment	Anodizing coloring - Goldcolor (Entire Body)	Anodizing coloring - Goldcolor(Entire Body)	Anodizing coloring - Goldcolor (Entire Body)
Sterile	No	No	No
Substantial Equivalence Discussion
The subject Duplex Abutment is substantially equivalent to the predicate devices in terms of intended useand technical characteristics. They are made of the same material and have similar design that all have thehex type. The size range of the predicate devices encompasses the size range of the subject device. All thedevices have anodizing coloring in the entire body.There might slight differences in design but it is very minor not affecting substantial equivalence.
Abutment 2- Simplex Abutment

Design & Size Range	Diameter: 3.5mmPost Height : 5.5mm-7.0mmGingival Height: 1mm -4.5mm	Diameter: 3.5mmPost Height : 5.0mm-9mmGingival Height: 1mm -4.5mm	Diameter: 4.5mm - 6.5mmPost Height : 5.5mmGingival Height: 1mm -5.5mm
Intended Use	Cement retained restoration	Cement retained restoration	Cement retained restoration
Material Composition	Ti 6AI 4V ELI, Gr.23	Ti 6AI 4V ELI, Gr.23	Ti 6AI 4V ELI, Gr.23
Surface Treatment	Anodizing coloring - Goldcolor(Entire Body)	Anodizing coloring - Goldcolor(Entire Body)	Anodizing coloring - Goldcolor(Entire Body)
Sterile	No	No	No
Design & Size Range
	Hex& Non-HexDiameter: 3.5mmGingival Height: 2mm -4mmAngle: 15° - 25°	Hex& Non-HexDiameter: 3.5mmGingival Height: 2.5mm –4.5mmAngle: 15°
Intended Use	Cement retained restoration	Cement retained restoration
Material Composition	Ti Gr.4	Ti Gr.4
Surface Treatment	Anodizing coloring – Goldcolor(Entire Body)	Anodizing coloring – Goldcolor(Entire Body)
Sterile	No	No

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device. All the devices have anodizing coloring in the entire body.

There might be slight differences in design but it is very minor not affecting substantial equivalence.

Abutment 3—Angled Abutment

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The subject Angled Abutment is substantially equivalent to the predicate devices in terms of intended use and technical characteristics. They are made of the same material and have similar design. The size range of the predicate devices encompasses the size range of the subject devices have anodizing coloring in the entire body.

There might be slight differences in design but it is very minor not affecting substantial equivalence. The major difference is that subject device has a model with is greater than the subject device, however, the test result of the fatigue test supported substantial equivalence.

Abutment 4- Temporary Abutment
Design & Size Range	HexDiameter: 3.5mmGingival Height: 1mm	HexDiameter: 3.0mmGingival Height: 1mm	Hex & Non-HexDiameter: 4.5mmGingival Height: 1mm
Intended Use	To manufacture temporaryprostheses	To manufacture temporaryprostheses	To manufacture temporaryprostheses
Material Composition	Ti Gr.4	Ti Gr.4	Ti Gr.4
Surface Treatment	No	No	No
Sterile	No	No	No
Substantial Equivalence Discussion

The subject Temporary Abutment is substantially equivalent to the predicate devices in terms of intended use and technical characteristics. They are made of the same material. The design is the same as the reference predicate device. The size range of the predicate devices encompasses the size range of the subject device.

Abutment 5- Ball Cap & O-ring
<Ball Cap & O-ring>Design & Size Range	Image: Ball Cap	Diameter: 5.0mmHeight: 3.85mm	Image: Ball Cap	Diameter: 5.0mmGingival Height: 3.85mm

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	Outer Diameter: 4.5mmInner Diameter: 1.5mm	Outer Diameter: 4.5mmInner Diameter: 1.5mm
Intended Use	Denture retained restoration	Denture retained restoration
Material CompositionHousingO-ring	Ti 6Al 4V ELI, Gr.23Silicon(USP Class VI grade)	Ti 6Al 4V ELI, Gr.23Silicon(USP Class VI grade)
Surface Treatment	No	No
Sterile	No	No
Substantial Equivalence Discussion

The subject ball cap and O-ring are the same as the predicate device in intended use, technological
characteristics, size, design, dimensions and material. There is no differ

7.3. Screws

	Subject Device	Predicate Device
510(K) Number	N / A	K150537
Device Name	Kisses Mini	MiNi Internal Implant System
Manufacturer	Achimhai Medical Corporation	MegaGen Implant Co., Ltd.
Indications for Use	The Kisses Mini is indicated for use inpartially or fully edentulous mandibles andmaxilla, in support of single or multiple-unitrestorations including; cemented retained,screw retained, or overdenturerestorations, and terminal or intermediateabutment support for fixed bridgework. TheKisses Mini is for single and two stagesurgical procedures. It is for delayedloading.The intended use of the 3.2 mm InternalHex fixtures is limited to the replacementof maxillary lateral incisors and mandibularincisors.The intended use of the single-piece posttype fixture is limited to replacement ofmandibular central and lateral incisors.The ball-type single-piece implant isintended for stabilization and retention ofoverdentures.	The MiNi Internal Implant System isintended for two stage surgical proceduresin the following situations and with thefollowing clinical protocols:· The intended use for the3.0 mm diameterMiNi implant is limited to the replacement ofmaxillary lateral incisors and mandibularincisors.· Immediate placement in extraction sitesand in situations with a partially orcompletely healed alveolar ridge.· It is intended for delayed loading.
Principle of Operation	· Abutment Screw is to connect theabutment to the fixture.· Cover Screw is to prevent tissue andbone to grow inside the implant.· Healing Screw is to help the soft tissueof gum naturally formed.	· Abutment Screw is to connect theabutment to the fixture.· Cover Screw is to prevent tissue andbone to grow inside the implant.· Healing Screw is to help the soft tissue ofgum naturally formed.
Abutment Screw

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Design & Size Range
	Tap: M1.4Image: Green Screw	Tap: M1.4Image: Silver Screw
Material Composition	Ti 6Al 4V ELI, Gr.23	Ti 6Al 4V ELI, Gr.23
Surface Treatment	Anodizing coloring(Entire Body)	No
Sterile	No	No

The subject abutment screw is substantially equivalent to the predicate device in intended use, technological characteristics, size, design, and material. The difference is that the subject screw has anodizing color but this coloring does not raise a questions in safety and effectiveness.

Cover Screw
Design & Size Range	Image: Green Cover ScrewTap: M1.4Ti 6Al 4V ELI, Gr.23Anodizing coloring(Entire Body)YesGamma	Image: Silver Cover ScrewTap: M1.4Ti 6Al 4V ELI, Gr.23Anodizing coloring(Entire Body)YesGamma

Substantial Equivalence Discussion

The subject cover screw is substantially equivalent to the predicate device in intended use, technological characteristics, size, design, and material. The anodizing color is different but the coloring does not raise a questions in safety and effectiveness.

Healing Screw
Design & Size Range	Image: Healing Screw	Image: Healing Screw
Diameter: 3.0 mm – 3.5mmCuff: 1.0mm - 4.5mmTap: M1.4		Diameter: 3.0 mm – 3.5mmCuff: 1.0mm - 4.5mmTap: M1.4
Material Composition	Ti 6Al 4V ELI, Gr.23	Ti 6Al 4V ELI, Gr.23
Surface Treatment	No	No
Sterile	Yes	Yes
Sterilization Method	Gamma	Gamma

Substantial Equivalence Discussion

The subject healing screw is substantially equivalent to the predicate device in intended use, technological characteristics, size, design, and material. The anodizing color is different but the coloring does not raise a questions in safety and effectiveness.

Substantial Equivalence Discussion for the Whole System

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Kisses Mini is substantially equivalent to the predicate devices in terms of intended use and technical characteristics. They are made of the same material and have similar design. The size range of the predicate device encompasses the size range of the subject device. There are slight differences in design, however, it is very minor not affecting substantial equivalence. The Kisses Mini indications for use differ from the predicate devices in some languages for specific types and size, however, these differences do not raise new concerns because limiting the use of each type is a more conservative surgical approach.

Another difference is in surface treatment for fixture that the subject device employs SLA and some of the predicate device employs RBM. For the subject deice, surface morphology, surface roughness analysis, and FT-IR analysis were performed to evaluate its characteristics, and the test results support it does not affect substantial equivalence.

Major difference in abutment is that it has a model with 25° angle which is greater than the subject device, however, the test result of the fatigue test supported substantial equivalence.

Based on the information and test results provided in submission, we conclude that the subject device is substantially equivalent to the predicate devices.

8. Non-Clinical Testing

. Sterilization validating testing has been performed in accordance with ISO 11137 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization.
. Three year of shelf life has been validated through accelerating testing.
Surface Morphology, Surface Roughness Analysis, and FT-IR Analysis were performed to evaluate the fixture surface characteristics after SLA treatment.
Other Performance tests: Visual inspection, Dimension, Packing inspection, Sterility, Adaption accuracy, Marginal adaptation, Compressive strength, Fatigue, Rotational sheer strength, Screw loosening torque tests
. The endotoxin testing will be conducted on every batch for the subject device. The USP <85> test method will be used to evaluate pyrogen limit specifications for the subject device. The testing limit is below 0.5 EU/mL. We referenced the USP 39 <85> Bacterial Endotoxin Test on the endotoxin limit which is 0.5 EU/mL.

9. Conclusion

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

Overall, the Kisses Mini has the following similarities to the predicate device:

- have the same intended use,
- use the same operating principle,
- incorporate the same design,
- incorporate the same material and the sterilization method.

Based on the similarities, we conclude that the Kisses Mini 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.