Who is the manufacturer of Biogensis Implant System-Kisses?

Biogenesis Co., Ltd. filed the 510(k) submission for Biogensis Implant System-Kisses (K142813).

What is the FDA product code for Biogensis Implant System-Kisses?

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

What is the regulatory pathway for Biogensis Implant System-Kisses?

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

Who can help prepare an FDA 510(k) submission like Biogensis Implant System-Kisses?

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.

Biogensis Implant System-Kisses

Q: What are the predicate devices for Biogensis Implant System-Kisses?

TS Fixture System by Ossetem Implant Co., Ltd. (K121995).

K142813 · Biogenesis Co., Ltd. · DZE · Jul 31, 2015 · Dental

Device Facts

Record ID	K142813
Device Name	Biogensis Implant System-Kisses
Applicant	Biogenesis Co., Ltd.
Product Code	DZE · Dental
Decision Date	Jul 31, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

Biogenesis Implant System - Kisses consists of titanium dental implants and associated abutments (Duplex, Simplex, Solid Screw, Ball, Temporary) used to replace missing teeth in edentulous or partially edentulous patients. Implants are surgically placed into the mandible or maxilla by a dental professional. The system features an internal hex connection, self-tapping threads, and SLA surface treatment. Components are used to support prosthetic restorations. The device provides a stable foundation for artificial teeth, restoring chewing function and aesthetics. Implants are provided sterile via gamma radiation; abutments are non-sterile. Clinical benefit is the restoration of oral function through fixed or removable dental prostheses.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included sterilization validation (ISO 17665-1/2, ANSI/AANI ST79), shelf-life testing (ASTM F1980), and biocompatibility testing (ISO 10993-1) in accordance with FDA guidance for endosseous dental implants.

Technological Characteristics

Materials: Titanium Grade 4 (implants/abutments), Ti 6Al 4V ELI Grade 23 (screws), Delrin 500P NC010 (temporary abutments). Surface: SLA treatment, anodizing/TiN coating. Connection: Internal hex. Dimensions: 3.8–5.5mm diameter, 7–14.5mm length. Sterilization: Gamma radiation for sterile components. Non-sterile components require chairside sterilization.

Indications for Use

Indicated for partially or fully edentulous adult patients requiring single or multiple-unit dental restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support. Suitable for single or two-stage surgical procedures with delayed loading.

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

TS Fixture System by Ossetem Implant Co., Ltd. (K121995)

Reference Devices

Implantium by Dentium Co., Ltd. (K041368)
Implantium Abutments by Dentium Co., Ltd. (K052823)
EZ Plus Implant System by Megagen Co., Ltd. (K070562)

Related Devices

K202039 — Honorst Implant System · Medimecca Co., Ltd. · Sep 25, 2020
K223924 — LW Implant System · Ossvis Co., Ltd. · Aug 8, 2023
K120089 — BIOGENESIS IMPLANT SYSTEM · Biogenesis Co., Ltd. · Mar 13, 2013
K111003 — BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL · Biodenta Swiss AG · Sep 15, 2011
K202479 — IBS Implant System · Innobiosurg Co., Ltd. · Sep 23, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 31, 2015 Biogenesis Co., Ltd. c/o Ms. Priscilla Chung LK Consulting Group USA, Inc. 2651 East Chapman Avenue Suite 110 Fullerton, California 92831 Re: K142813 Trade/Device Name: Biogenesis™ Implant System - Kisses Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: June 26, 2015 Received: July 01, 2015 Dear Ms. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. 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) K142813 Device Name Biogenesis Implant System -Kisses #### Indications for Use (Describe) The Biogenesis Implant System –Kisses is in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented 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. Type of Use (Select one or both, as applicable) × Prescription Use (Part 21 CFR 801 Subpart D) ■ Over-The-Counter Use (21 CFR 801 Subpart C) ## 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}------------------------------------------------ # 510(k) Summary (K142813) This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: 07/30/2015 ## 1. Applicant / Submitter Biogenesis Co., Ltd. Mecha Zone #1109, SK Techno Park, 50. Wanam-Ro. Seongsan-Gu. Changwon-Si, Gyeongsangnam-Do, Republic of Korea, 642-971 Tel: +82-55-607-0345 Fax: +82-55-607-0347 ## 2. Submission Correspondent Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton CA 92831 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com ## 3. Device - Trade Name: Biogenesis™ Implant System Kisses - · Common Name: Dental Implant - · Classification Name: Endosseous Dental Implant - · Product Code: DZE, NHA - Classification regulation: 21CFR872.3640 ## 4. Predicate Device: ## - Primary Predicate Device: TS Fixture System by Ossetem Implant Co., Ltd. (K121995) ## · Reference Predicate Devices: Dentium Co., Ltd Implantium by Dentium Co., Ltd. (K041368) Implantium Abutments by Dentium Co., Ltd. (K052823) EZ Plus Implant System by Megagen Co., Ltd. (K070562) {4}------------------------------------------------ # 5. Description: The Biogenesis 110 Implant System - Kisses is a dental implant system made of titanium intended to be surgically placed in the bone of the upper or lower jaw arches. This product is a substructure of a dental implant system to replace a single tooth, partial 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 Biogenesis™ Implant System offers bone level implants in the size range of 3.8 – 5.5 mm diameter with 7 – 14.5mm length. - Diameter: 3.8mm / 4.2mm / 5.1mm / 5.5mm x Length: 7mm / 8mm / 9.5mm / 11mm / 12.5mm / 14.5mm The Biogenesis TM Implant System also offers the following components. - · Duplex Abutment - Duplex Milling Abutment - Simplex Abutment - Temporary Abutment - · Solid Screw Abutment - · Ball Abutment - Ball Cap The implants are intended for use with straight implant only straight implants are included in the submission. # 6. Indication for use: 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 is for single and two stage surgical procedures. It is intended for delayed loading. # 7. Basis for Substantial Equivalence The Biogenesis Implant System – Kisses is substantially equivalent to previously marketed devices as presented in the comparison tables below. The subject device is similar to the predicate devices based on the intended use, the principle of operations, the materials, the surface treatment, the size range and the technological characteristics. The verbiage of the Indications for Use of the subject device is slightly different than that of the declared predicates; however, these slight differences in wording does not change the intended use of the subject device has {5}------------------------------------------------ compared to the declared predicate. In addition, the external design of the subject device is slightly different from the predicate devices; however, the performance testing provided in this 510k submission supports that the subject device is substantially equivalent to the predicate devices. # Comparison Chart #### 1) Fixture | | Subject Device | Primary Predicate Device | Reference Predicate Device | |-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(K) Number | N / A | K121995 | K041368 | | Device Name | Biogenesis Implant System - Kisses | TS Fixture System | Dentium Co., Ltd Implantium | | Manufacturer | Biogenesis | Osstem | Dentium | | Type | Internal hex | Internal hex | Internal hex | | Design & Size Range | Diameter: 3.8 – 5.5 mm | Diameter: 3.5 – 5.0 mm | Diameter: 3.4 – 5.8 mm | | | Length: 7 – 14.5 mm | Length: 7-15 mm | Length: 7-15 mm | | Indications for Use | 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 | The TS fixture system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ts fixture system is compatible with abutment in the et/ss implant system | The dentium co., ltd. Implantium 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, and to restore the patient's chewing function. This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type i, or iii bone) provided good initial stability (> 40 ncm) is achieved. Not intended for immediate loading. | | 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 | | 510(K) Number | Subject Device | Reference Predicate Device | Reference Predicate Device | | N / A | Biogenesis Implant System - Kisses | K052823 | K070562 | | Device Name | Biogenesis Implant System - Kisses | Implantium Abutments | EZ Plus Implant System | | Manufacturer | Biogenesis | Dentium | Megagen | | Type | Internal | Internal | internal | | Indications for Use | 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 | The implantium abutments are intended to be used with the im-plantium root-form endosseous dental implant to aid in prosthetic rehabilitation including overdenture retention. After the root-form endosseous dental implant is surgically placed, the endosseous dental implant abutment device is attached to it. | The ez plus implant systems are intended to be surgically placed in the upper or lower jaw to support prosthetic devices, such as artifical teeth and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. Large angle abutments (e.g. 25 degree) on small diameter implants of the ez plus internal connection system are intended for the anterior region of the mouth and not intended for use in the posterior region of the mouth due to limited strenth of the implant | | | Abutment 1- Duplex Abutment | | | | <Duplex Abutment> Design & Size Range | Hex & Non-Hex Diameter: 4.0mm - 6.5mm Post Height : 4.0mm - 7.0mm Gingival Height: 1mm - 7.0mm | Hex & Non-Hex Diameter: 4.5mm - 6.5mm Post Height : 5.5mm Gingival Height: 1mm - 5.5mm | Trip & Non-Trip Diameter: 4mm - 6mm Post Height : 5mm Gingival Height: 1mm - 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) | TiN coating - Gold color (Partly) | Anodizing coloring - Gold color(Entire Body) | | Sterile | No | No | No | | | Abutment 2- Duplex Milling Abutment | | | | <Duplex Milling Abutment> Design & Size Range | | | | {6}------------------------------------------------ #### 2) Abutment {7}------------------------------------------------ | | Hex & Non-Hex Diameter: 4.0mm - 6.5mm Gingival Height: 1.5mm – 3.0mm | Hex & Non-Hex Diameter: 4.0mm - 6.5mm Gingival Height: 1.5mm – 3.0mm | Trip & Non-Trip Diameter: 5mm - 6mm Gingival Height: 1mm – 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) | TiN coating - Gold color (Partly) | Anodizing coloring - Gold color(Entire Body) | | Sterile | No | No | No | | Abutment 3- Simplex Abutment | | | | | <Simplex Abutment> Design & Size Range | Diameter: 4.0mm - 6.5mm Post Height : 4.0mm - 5.5mm Gingival Height: 1mm – 7.0mm | Diameter: 4.5mm - 6.5mm Post Height : 5.5mm Gingival Height: 1mm - 5.5mm | Diameter: 4mm - 6mm Post Height : 3.5 / 5mm Gingival Height: 1mm - 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) | TiN coating - Gold color (Partly) | Anodizing coloring - Gold color(Entire Body) | | Sterile | No | No | No | | Abutment 4- Solid Screw Abutment | | | | | <Solid Screw> Design & Size Range | Diameter: 4.8mm Post Height : 4.0mm – 7.0mm Gingival Height: 1.0mm – 7.0mm | Diameter: 4.5mm - 6.5mm Post Height : 5.5mm Gingival Height: 1mm - 5.5mm | Diameter: 4mm - 6mm Post Height : 3.5 / 5mm Gingival Height: 1mm - 5.0mm | | 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) | TiN coating - Gold color (Partly) | Anodizing coloring - Gold color(Entire Body) | | Sterile | No | No | No | | Abutment 5- Temporary Abutment | | | | | <Temporary Abutment> Design & Size Range | Hex & Non-Hex | | Hex & Non-Hex | {8}------------------------------------------------ | | Diameter: 4.0 / 4.5mm Gingival Height: 1mm | Hex & Non-Hex Diameter: 4.5mm Gingival Height: 1mm | Diameter: 4mm / 4.5mm Gingival Height: 1.5mm | |--------------------------------------|------------------------------------------------------|----------------------------------------------------------|-------------------------------------------------| | Intended Use | To manufacture temporary prostheses | To manufacture temporary prostheses | To manufacture temporary prostheses | | Material Composition | Ti Gr.4 | Ti Gr.4 | Ti Gr.3 | | Surface Treatment | No | No | No | | Sterile | No | No | No | | Material Composition | Delrin 500P NC010 | Delrin 500P NC010 | Delrin 500P NC010 | | Surface Treatment | No | No | No | | Sterile | No | No | No | | Abutment 6- Ball abutment | | | | | <Solid Screw> Design & Size Range | Diameter: 3.0, 3.5mm Gingival Height: 0.5mm – 7mm | Diameter: 3.3mm –3.5mm Gingival Height: 0mm - 5mm | | | Intended Use | Cement retained restoration | Cement retained restoration | | | Material Composition | Ti 6Al 4V ELI, Gr.23 | Ti Gr.4 | | | Surface Treatment | Anodizing coloring – Gold color(Entire Body) | No | | | Sterile | No | No | | #### 3) Screws | | Subject Device | Reference Predicate Device | |-----------------------------------------|----------------------------------------|--------------------------------------------------| | 510(K) Number | N / A | K052823 | | Device Name | Biogenesis Implant System - Kisses | Implantium Abutments | | Manufacturer | Biogenesis | Dentium | | Abutment Screw | | | | <Abutment Screw> Design & Size Range | Image: Abutment Screw Subject Device | Image: Abutment Screw Reference Predicate Device | | Intended Use | To connect the abutment to the fixture | To connect the abutment to the fixture | | Material Composition | Ti 6Al 4V ELI, Gr.23 | Ti 6Al 4V ELI, Gr.23 | | Surface Treatment | No | No | | Sterile | No | No | | Cover Screw | | | | <Cover Screw> Design & Size Range | Image: Cover Screw Subject Device | Image: Cover Screw Reference Predicate Device | {9}------------------------------------------------ | Intended Use | To provide sealing effect for fixture | To provide sealing effect for fixture | |----------------------------------------|-----------------------------------------------------|-----------------------------------------------------| | Material Composition | Ti 6Al 4V ELI, Gr.23 | Ti 6Al 4V ELI, Gr.23 | | Surface Treatment | Anodizing coloring(Entire Body) | Anodizing coloring(Entire Body) | | Sterile | Yes | Yes | | Sterilization Method | Gamma | Gamma | | Healing Screw | | | | <Healing Screw> Design & Size Range | Image: Healing Screw | Image: Healing Screw | | Intended Use | To help the soft tissue of gum naturally formed. | To help the soft tissue of gum naturally formed. | | 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 | # 8. Non-Clinical Testing Various performance testing has been performed on the Biogenesis Implant System-Kisses and the test results met the pre-set criteria. Testing included: - · Sterilization validating testing according to ISO 17665-1/2 and ANSI/AANI ST79 - · Shelf life testing according to ASTM F1980 - · Biocompatibility testing per ISO 10993-1 - · Conformance to FDA Guidance Document for Endosseous Dental Implants and Abutments There might be some differences in sterilization parameters, shelf life and manufacturing processes between the subject device and the predicate devices, however, the test results supported that the subject device is substantially equivalent to the predicate devices. # 9. Conclusion The subject device and the predicate devices have the same intended use and have similar technological characteristics. Overall, the Biogenesis Implant System -Kisses has the following similarities to the predicate devices: - has the same intended use, - · uses the same operating principle, - · incorporates the same basic design, - incorporates the same material and the surface treatment. {10}------------------------------------------------ Based on the similarities, we conclude that the Biogenesis Implant System –Kisses is substantially equivalent to the predicate devices.