Who is the manufacturer of Kisses Mini?

Achimhai Medical Corporation filed the 510(k) submission for Kisses Mini (K170394).

What is the FDA product code for Kisses Mini?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Kisses Mini?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Kisses Mini?

MiNi Internal Implant System (K150537); S-MiNi Implant System (K112540).

Who can help prepare an FDA 510(k) submission like Kisses Mini?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Kisses Mini

K170394 · Achimhai Medical Corporation · DZE · Oct 6, 2017 · Dental

Device Facts

Record ID	K170394
Device Name	Kisses Mini
Applicant	Achimhai Medical Corporation
Product Code	DZE · Dental
Decision Date	Oct 6, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Kisses Mini is a dental implant system comprising fixtures (2-piece, post, and ball types), abutments, and screws. Fixtures are surgically placed into the jawbone to replace lost tooth roots; they feature self-tapping threads and SLA surface treatment. Abutments (duplex, simplex, angled, temporary) couple to fixtures to support prosthetic restorations. Ball-type implants use O-ring attachments for overdenture retention. Used in clinical dental settings by trained professionals for single or two-stage surgical procedures with delayed loading. The system provides structural support for artificial teeth, restoring chewing function and stabilizing dentures. Benefits include improved oral function and prosthetic retention for edentulous patients.

Clinical Evidence

Bench testing only. Includes sterilization validation (ISO 11137, ISO 17665), shelf-life validation, surface characterization (morphology, roughness, FT-IR), and mechanical performance testing (fatigue, compressive strength, rotational shear, screw loosening torque). Endotoxin testing per USP <85> (limit <0.5 EU/mL).

Technological Characteristics

Materials: Ti Gr.4 (fixtures), Ti 6Al 4V ELI Gr.23 (abutments/screws), Silicon (O-rings). Surface: SLA treatment. Sterilization: Gamma. Form factor: Internal hex, post, and ball-type fixtures; various abutment geometries. Connectivity: Mechanical coupling.

Indications for Use

Indicated for partially or fully edentulous patients (maxilla/mandible) requiring single or multiple-unit restorations (cemented/screw-retained/overdenture) or fixed bridgework support. Specific fixtures limited to maxillary lateral incisors and mandibular incisors. Ball-type implants indicated for overdenture stabilization.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

MiNi Internal Implant System (K150537)
S-MiNi Implant System (K112540)

Reference Devices

Biogenesis Implant System – Kisses (K142813)

Related Devices

K202039 — Honorst Implant System · Medimecca Co., Ltd. · Sep 25, 2020
K240091 — NB Mini Implant System · Arum Dentistry Co., Ltd. · Apr 26, 2024
K162004 — PREMIUM Implant Systems SHELTA Implant Systems · Sweden & Martina S.P.A. · Dec 5, 2016
K151588 — maxFit II Dental Implant System · Taiwan Implant Technology Company, Ltd. · Apr 25, 2016
K192197 — Magicore II System · Innobiosurg Co., Ltd. · Apr 28, 2020

Submission Summary (Full Text)

{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}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 re…