Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental implant system and its components, focusing on mechanical properties, sterilization, and intended use. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of such technologies.

Therapeutic

Yes
The device is described as a dental implant system intended to replace lost tooth roots and support various dental restorations, thus providing a therapeutic benefit for edentulous patients.

Diagnostic

No

The device description and intended use indicate that the Kisses Mini is a dental implant system used for supporting restorations in the maxilla. It is a physical device that replaces missing teeth, not a device that diagnoses conditions or diseases. The performance studies also focus on physical properties and sterility, not diagnostic accuracy.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical implant components (2-Piece Type, Post Type, and Ball Type fixtures) which are hardware.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
Device Description and Intended Use: The description and intended use clearly state that the Kisses Mini is a dental implant system designed to replace lost teeth and roots in the jawbone. It is a physical device implanted into the body.
Lack of IVD Characteristics: There is no mention of testing biological samples, analyzing biomarkers, or providing diagnostic information based on laboratory tests.

The device is a surgical implant used for structural support in dental restorations, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DZE, NHA

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.

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 ●

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

partially or fully edentulous mandibles and maxilla

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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 Bacterial Endotoxin Test on the endotoxin limit which is 0.5 EU/mL.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K150537, K112540

Reference Device(s)

K142813

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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.

1

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

2

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 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.

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)

3

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4

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.

5

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.

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

6

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 name
has changed from Biogenesis
to Achimhai.)
Type	Internal hex	Internal hex	Internal hex
Design & Size Range	Diameter: 3.2 mm
Length: 8 - 14.5 mm	Diameter: 3.0 – 3.4 mm
Length: 8-14.5 mm	Diameter: 3.5 - 5.5 mm
Length: 7-15 mm
Indications 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
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 MiNi Internal Implant
System is intended for two
stage surgical procedures in
the following situations and
with the following clinical
protocols:
• The intended use for the 3.0
mm diameter MiNi implant is
limited to the replacement of
maxillary lateral incisors and
mandibular incisors.
• Immediate placement in
extraction sites and in
situations with a partially or
completely healed alveolar
ridge.
• It is intended for delayed
loading.	The Biogenesis Implant
System -Kisses 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
terminal or intermediate
abutment support for fixed
bridgework.
The Biogenesis Implant
System - Kisses is for single
and two stage surgical
procedures. It is for delayed
loading.

7

| | The ball-type single-piece
implant is intended for
stabilization and retention of
overdentures. | | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of
Operation | The device 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. | The device 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. | The device 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. |
| 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 mm
Length: 8 - 14.5 mm
Cuff: 2.5 – 4.0 mm
Post: 8.0 mm	Image: A dental implant.
Diameter: 2.0 – 3.5 mm
Length: 7-15 mm
Cuff: 2.0 mm
Post: 10.0 mm
Intended 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	The S-MiNi Implant System is intended to use
in the treatment of missing mandibular central
and lateral incisors to support prosthetic
device, such as artificial teeth, in order to
restore chewing function partially edentulous.

510(k) Submission

8

| 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 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.
Principle of
Operation	The device is a substructure of a dental
implant system to replace a single tooth and
the lost root of edentulous patients. It consists
of the single thread part and the post part; the
single thread part to be fixed to the bone, and
the cutting edge part with the self-tapping
function.	The device is a substructure of a dental
implant system to replace a single tooth and
the lost root of edentulous patients. It consists
of the single thread part and the post part; the
single thread part to be fixed to the bone, and
the cutting edge part with the self-tapping
function.
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

9

Design & Size Range
Image: Implant	Image: Implant
Diameter: 2.8 – 3.0 mm
Length: 8 - 14.5 mm
Cuff: 2.0-4.0 mm	Diameter: 2.0 – 3.5 mm
Length: 7 - 15 mm
Cuff: 3.0-4.0 mm
Intended 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
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. | The S-MiNi Implant System is intended to be
place in the bone of the upper or lower jaw
arches to provide support the prosthetic
devices to restore the patient's chewing
function, including the denture stabilization.
S-MiNi Implant System is intended for single
use only |
| Principle of Operation | |
| The device is a substructure of a dental
implant system to replace a single tooth and
the lost root of edentulous patients. It consists
of the single thread part and the ball part; the
single thread part to be fixed to the bone, the
cutting edge part with the self-tapping
function, and the ball part for detachable
denture. | The device is a substructure of a dental
implant system to replace a single tooth and
the lost root of edentulous patients. It consists
of the single thread part and the ball part; the
single thread part to be fixed to the bone, the
cutting edge part with the self-tapping
function, and the ball part for detachable
denture. |
| 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.

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.

10

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.

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 Medical
Corporation	MegaGen Implant Co., Ltd.	Achimhai Medical Corporation
(Note: Our company name
has changed from Biogenesis
to Achimhai.)
Type	Internal	Internal	Internal hex
Indications 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 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.	The MiNi Internal Implant
System is intended for two
stage surgical procedures in
the following situations and
with the following clinical
protocols:
· The intended use for the 3.0
mm diameter MiNi implant is
limited to the replacement of
maxillary lateral incisors and
mandibular incisors.
· Immediate placement in
extraction sites and in
situations with a partially or
completely healed alveolar
ridge.
• It is intended for delayed
loading.	The Biogenesis Implant
System -Kisses 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
terminal or intermediate
abutment support for fixed
bridgework.
The Biogenesis Implant
System - Kisses is for single
and two stage surgical
procedures. It is for delayed
loading.
Principle of Operation	The abutments are to be
coupled to the fixtures to
make temporary or final
prosthesis.	The abutments are to be
coupled to the fixtures to
make temporary or final
prosthesis.	The abutments are to be
coupled to the fixtures to
make temporary or final
prosthesis.
Abutment 1- Duplex Abutment


Design & Size Range	Hex
Diameter: 3.5mm
Post Height : 5.5mm-7.0mm
Gingival Height: 1mm -
4.5mm	Hex
Diameter: 3.5mm
Post Height : 5.0mm-9.0mm
Gingival Height: 1mm -
4.5mm	Hex & Non-Hex
Diameter: 4.5mm - 6.5mm
Post Height : 5.5mm
Gingival 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 - Gold
color (Entire Body)	Anodizing coloring - Gold
color(Entire Body)	Anodizing coloring - Gold
color (Entire Body)
Sterile	No	No	No
Substantial Equivalence Discussion
The subject Duplex 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 that all have the
hex type. The size range of the predicate devices encompasses the size range of the subject device. All the
devices 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: 3.5mm
Post Height : 5.5mm-7.0mm
Gingival Height: 1mm -
4.5mm	Diameter: 3.5mm
Post Height : 5.0mm-9mm
Gingival Height: 1mm -
4.5mm	Diameter: 4.5mm - 6.5mm
Post Height : 5.5mm
Gingival 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 - Gold
color(Entire Body)	Anodizing coloring - Gold
color(Entire Body)	Anodizing coloring - Gold
color(Entire Body)
Sterile	No	No	No

Design & Size Range
	Hex& Non-Hex
Diameter: 3.5mm
Gingival Height: 2mm -
4mm
Angle: 15° - 25°	Hex& Non-Hex
Diameter: 3.5mm
Gingival Height: 2.5mm –
4.5mm
Angle: 15°
Intended Use	Cement retained restoration	Cement retained restoration
Material Composition	Ti Gr.4	Ti Gr.4
Surface Treatment	Anodizing coloring – Gold
color(Entire Body)	Anodizing coloring – Gold
color(Entire Body)
Sterile	No	No

11

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

12

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	Hex
Diameter: 3.5mm
Gingival Height: 1mm	Hex
Diameter: 3.0mm
Gingival Height: 1mm	Hex & Non-Hex
Diameter: 4.5mm
Gingival Height: 1mm
Intended Use	To manufacture temporary
prostheses	To manufacture temporary
prostheses	To manufacture temporary
prostheses
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

Design & Size Range	Image: Ball Cap	Diameter: 5.0mm
Height: 3.85mm	Image: Ball Cap	Diameter: 5.0mm
Gingival Height: 3.85mm

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| | Outer Diameter: 4.5mm
Inner Diameter: 1.5mm | Outer Diameter: 4.5mm
Inner Diameter: 1.5mm |
|-------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|
| Intended Use | Denture retained restoration | Denture retained restoration |
| Material Composition
Housing
O-ring | Ti 6Al 4V ELI, Gr.23
Silicon(USP Class VI grade) | Ti 6Al 4V ELI, Gr.23
Silicon(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 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 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.	The MiNi Internal Implant System is
intended for two stage surgical procedures
in the following situations and with the
following clinical protocols:
· The intended use for the3.0 mm diameter
MiNi implant is limited to the replacement of
maxillary lateral incisors and mandibular
incisors.
· Immediate placement in extraction sites
and in situations with a partially or
completely healed alveolar ridge.
· It is intended for delayed loading.
Principle of Operation	· Abutment Screw is to connect the
abutment to the fixture.
· Cover Screw is to prevent tissue and
bone to grow inside the implant.
· Healing Screw is to help the soft tissue
of gum naturally formed.	· Abutment Screw is to connect the
abutment to the fixture.
· Cover Screw is to prevent tissue and
bone to grow inside the implant.
· Healing Screw is to help the soft tissue of
gum naturally formed.
Abutment Screw

14

|

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

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 – 3.5mm
Cuff: 1.0mm - 4.5mm
Tap: M1.4		Diameter: 3.0 mm – 3.5mm
Cuff: 1.0mm - 4.5mm
Tap: 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

15

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 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 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.