Who is the manufacturer of ARi ExCon Implant System?

Megagen Implant Co., Ltd. filed the 510(k) submission for ARi ExCon Implant System (K231967).

What is the FDA product code for ARi ExCon Implant System?

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

What is the regulatory pathway for ARi ExCon Implant System?

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

What are the predicate devices for ARi ExCon Implant System?

External Hex Implants (K163634).

Who can help prepare an FDA 510(k) submission like ARi ExCon Implant System?

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.

ARi ExCon Implant System

K231967 · Megagen Implant Co., Ltd. · DZE · Dec 7, 2023 · Dental

Device Facts

Record ID	K231967
Device Name	ARi ExCon Implant System
Applicant	Megagen Implant Co., Ltd.
Product Code	DZE · Dental
Decision Date	Dec 7, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The ARi ExCon Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: - Delayed loading - Immediate loading when good primary stability is achieved and with appropriate occlusal loading. For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.

Device Story

ARi ExCon Implant System consists of endosseous dental implants and prosthetic components (abutments, screws). Implants are surgically placed in maxillary or mandibular molar regions to provide prosthetic support for crowns, bridges, and overdentures. System components include fixtures (CP Ti Grade 4), cover screws, healing abutments, scan healing abutments, temporary abutments, EZ post abutments, angled abutments, solid abutments, ZrGEN abutments (zirconia/titanium base), and TiGEN abutments. Components are connected to implants to facilitate prosthetic rehabilitation. Used by dental clinicians in clinical settings. Output is a stable foundation for dental restorations, restoring patient chewing function. Benefits include improved masticatory function and prosthetic stability.

Clinical Evidence

Bench testing only. Performance evaluated via fatigue testing per ISO 14801 and Class II Special Controls Guidance for Root-form Endosseous Dental Implants. Biocompatibility assessed per ISO 10993-1. MR compatibility assessed per FDA guidance, establishing MR Conditional status based on reference device K230618.

Technological Characteristics

Materials: CP Ti Grade 4 (ASTM F67) for fixtures; Ti-6Al-4V ELI (ASTM F136-13) for abutments/screws; Zirconia (ISO 13356) for ZrGEN top-half. Surface: SLA (implants), anodizing/machined (abutments). Connection: Conical or External Hex. Sterilization: Irradiation (sterile components) or steam sterilization (non-sterile components).

Indications for Use

Indicated for partially or fully edentulous individuals requiring prosthetic support for dental restorations (crowns, bridges, overdentures) in maxillary or mandibular molar areas. Supports delayed or immediate loading protocols when primary stability is achieved.

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

External Hex Implants (K163634)

Reference Devices

Noris Medical Dental Implants System Cortical (K210852)
Straumann TLX Implant System TLX S (K200586)
AnyOne External Implant System (K203554)
BLUEDIAMOND IMPLANT System (K182448)
MiNi Internal Implant System (K150537)
AnyOne Internal Implant System (K123988)
AnyRidge Internal Implant System (K110955)
ST Internal Implant System (K192347)
AnyOne Onestage Implant System (K210161)
TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment (K220562)
XPEED AnyRidge Implant System (K122231)
MegaGen Dental Implant Systems Portfolio MR Conditional (K230618)

Related Devices

K203554 — AnyOne External Implant System · Megagen Implant Co., Ltd. · Aug 28, 2021
K171297 — AR_N Type Implant System · Biotem Co., Ltd. · Jan 31, 2018
K211090 — ZENEX Implant System · Izenimplant Co., Ltd. · Apr 13, 2022
K163640 — QZA and RS Dental Implant Systems · Trinon Titanium GmbH · May 3, 2017
K200867 — Implantswiss Dental Implant System and Implantswiss Dental Abutment System · Novodent SA · Apr 28, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 7, 2023 MegaGen Implant Co., Ltd. Kyung-Hee Back Official Correspondent 45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun Daegu, 42921 REPUBLIC OF KOREA Re: K231967 Trade/Device Name: ARi ExCon Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 2, 2023 Received: November 2, 2023 Dear Kyung-Hee Back: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Andrew I. Steen -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231967 Device Name ARi ExCon Implant System Indications for Use (Describe) The ARi ExCon Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: - Delayed loading - Immediate loading when good primary stability is achieved and with appropriate occlusal loading. For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture. 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ #### V. 510(k) Summary This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR Part 807.92. Date: December 6, 2023 # 1. Applicant / Submitter MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828 # 2. Submission Correspondent Kyung-Hee Back MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: +82-53-222-3864 Fax: +82-53-289-3414 Email: ra9@imegagen.com # 3. Device | . Trade Name: | ARi ExCon Implant System | |---------------|--------------------------| |---------------|--------------------------| - Endosseous Dental Implant Common Name: . - Implant, Endosseous, Root-Form - Primary Product Code: . Classification Name: - DZE - . Secondary Product Code: NHA - Classification regulation: Class II, 21 CFR 872.3640 . #### Predicate Device 4. . # • Primary Predicate Device: K163634 - External Hex Implants # •Reference Device: - K210852 Noris Medical Dental Implants System Cortical - K200586 Straumann TLX Implant System TLX S - K203554 AnyOne External Implant System - K182448 BLUEDIAMOND IMPLANT System - K150537 MiNi Internal Implant System - K123988 AnyOne Internal Implant System - K110955 AnyRidge Internal Implant System - K192347 ST Internal Implant System - K210161 AnyOne Onestage Implant System - K220562 TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment - K122231 XPEED AnyRidge Implant System - K230618 MegaGen Dental Implant Systems Portfolio MR Conditional {5}------------------------------------------------ # 5. Description - . The ARi ExCon Implant is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function. The Abutments are prosthetic components directly or indirectly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation, allows single & multiple prosthetic restorations. | Device | | Content | | |----------------|-----------------------|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. Fixture | ARi ExCon Implant | Description | The ARi ExCon Implant is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function. | | | | Material | CP Ti Grade 4 of ASTM F67 | | | | Dimension (Diameter & Total Length) | · Normal Thread Ø 3.8 x 11.0, 13.0, 15.0 mm Ø 4.3 x 11.0, 13.0, 15.0 mm Ø 4.8 x 11.0, 13.0, 15.0 mm Ø 5.3 x 11.0, 13.0, 15.0 mm | | | | | · Deep Thread Ø 4.3 x 11.0, 13.0, 15.0 mm Ø 4.8 x 11.0, 13.0, 15.0 mm Ø 5.3 x 11.0, 13.0, 15.0 mm Ø 5.8 x 11.0, 13.0, 15.0 mm | | 2. Prosthetics | Cover Screw | Description | The Cover Screw is used in conjunction with fixture for protecting the inner structure of a fixture, and exposed fixture platform after fixture placement. | | | | Material | Ti-6Al-4V ELI of ASTM F136-13 | | | | Dimension (Diameter & Total Length) | Ø 2.6 x 3.1 mm Ø 3.2 x 3.1 mm Ø 3.4 x 3.6, 4.1, 5.1 mm Ø 4.0 x 3.6, 4.1, 5.1 mm | | | | Angulation | Straight | | | Healing Abutment | Description | The Healing Abutment is used in conjunction with fixture and helps to form suitable emergence profile during period of gingival healing. | | | | Material | Ti-6Al-4V ELI of ASTM F136-13 | | | | Dimension (Diameter & Total Length) | Ø 3.7 x 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0 mm Ø 4.2 x 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0 mm Ø 5.2 x 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0 mm Ø 6.2 x 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0 mm | | | | Angulation | Straight | | | Scan Healing Abutment | Description | The Scan Healing Abutment is used for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration. | | | | Material | Ti-6Al-4V ELI of ASTM F136-13 | | | | Dimension (Diameter & Total Length) | Ø 4.2 x 4.5, 5.5, 7.5, 9.5 mm Ø 4.7 x 4.5, 5.5, 7.5, 9.5 mm Ø 5.7 x 4.5, 5.5, 7.5, 9.5 mm | | | | Angulation | Straight | | | S.H.A Screw | Description | At the top of the S.H.A Screw, an internal hex groove is processed so that it can be fastened with a driver, and at the bottom, a thread is formed so that it can be fastened with the internal female screw of the fixture. | | | | Material | Ti-6Al-4V ELI of ASTM F136-13 | | | | Dimension (Diameter & Total Length) | Ø 2.0 x 5.33, 6.33, 8.33, 10.33 mm | | | | Angulation | Straight | | | Temporary Abutment | Description | The Temporary Abutment is used in conjunction with fixture to provide support for provisional restoration. | | | | Material | Ti-6Al-4V ELI of ASTM F136-13 | | | | Dimension (Diameter & Total Length) | Ø 3.5, 4.0, 4.5 x 12.0 mm Ø 3.5 x 10.0, 12.0, 14.0 mm Ø 3.5, 4.0, 5.0, 6.0 x 10.0 mm | | | | Angulation | Straight | #### י The ARi ExCon Implant System is consisted of the following components. {6}------------------------------------------------ | | EZ Post Abutment | Description | The EZ Post Abutment is used in conjunction with fixture to provide support for cement and screw retained type final prosthesis. | | | | | | | | |--|---------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-------------------------------------------|-------------------------------|--|--|--|-------------------------------------------| | | | Material | Ti-6Al-4V ELI of ASTM F136-13 | | | | | | | | | | | Dimension (Diameter & Total Length) | Ø 3.5 x 7.0, 8.0, 9.0, 10.0, 11.0, 12.0 mm Ø 4.0 x 7.0, 8.0, 9.0, 10.0, 11.0, 12.0 mm Ø 5.0 x 7.0, 8.0, 9.0, 10.0, 11.0, 12.0 mm Ø 6.0 x 7.0, 8.0, 9.0, 10.0, 11.0, 12.0 mm | | | | | | | | | | | Angulation | Straight | | | | | | | | | | Angled Abutment | Description | The Angled Abutment is used in conjunction with fixture and used for correcting the prosthetic angulation of implant. | | | | | | | | | | | Material | Ti-6Al-4V ELI of ASTM F136-13 | | | | | | | | | | | Dimension (Diameter & Total Length) | Ø 4.0 x 9.0, 10.0, 11.0, 12.0 mm Ø 5.0 x 9.0, 10.0, 11.0, 12.0 mm Ø 6.0 x 9.0, 10.0, 11.0, 12.0 mm | | | | | | | | | | | Angulation | 15°, 25° | | | | | | | | | | Solid Abutment | Description | The Solid Abutment is used in conjunction with fixture to provide support for final prosthesis, and used in cement retained type prosthesis only. | | | | | | | | | | | Material | Ti-6Al-4V ELI of ASTM F136-13 | | | | | | | | | | | Dimension (Diameter & Total Length) | Ø 2.3 x 7.9, 9.9, 11.9 mm | | | | | | | | | | | Angulation | Straight | | | | | | | | | | ZrGEN Abutment | Description | The ZrGEN Abutment is a two-piece abutment composed of the stock titanium base cemented together with the zirconia top-half to complete the final finished device. | | | | | | | | | | | Material | Ti-6Al-4V ELI of ASTM F136-13 | | | | | | | | | | | Dimension (Diameter & Total Length) | Ø 4.0 x 6.5, 7.5, 8.0, 8.5, 9.0, 10.0, 11.0, 12.0 mm Ø 4.5 x 6.5, 7.5, 8.0, 8.5, 9.0, 10.0, 11.0, 12.0 mm | | | | | | | | | | | | The allowable ranges of design parameters are follows: | | | | | | | | | | | | Titanium base | Minimum wall thickness (mm) | 0.5 | | | | | | | | | | | Minimum gingival collar (Ø) | 4.0 | | | | | | | | | | | Maximum gingival collar (Ø) | 4.5 | | | | | | | | | | | Minimum post height (mm) | 4.5 | | | | | | | | | | | Maximum post height (mm) | 8.0 | | | | | | | | | | The allowable ranges of design parameters after CAD/CAM patient-matching are follows: | | | | | | | | | | | | Zirconia top-half | Minimum wall thickness (mm) | 0.5 | | | | | | | | | | | Minimum gingival collar (Ø) | 8 | | | | | | | | | | | Maximum gingival collar (Ø) | 10 | | | | | | | | | | | Minimum gingival collar height (mm) | 2 | | | | | | | | | | | Maximum gingival collar height (mm) | 5 | | | | | | | | | | | Minimum post height (mm) | 7 | | | | | | | | | | | Maximum post height (mm) | 15 | | | | | | | | | Angulation | Straight | | | | | | | | | | TiGEN Abutment | Description | The TiGEN Abutment is machined with the final prosthetic in accordance with the intraoral structure. | | | | | | | | | | | Material | Ti-6Al-4V ELI of ASTM F136-13 Ø 10.0, 12.0 x 26.0 mm | | | | | | | | | | | | The allowable ranges of design parameters after CAD/CAM patient-matching are follows: | | | | | | | | | | | Dimension (Diameter & Total Length) & Angulation | Standard Type | Minimum wall thickness (mm) | 0.05 | | | | | | | | | | | Maximum angulation (°) | 30 | | | | | | | | | | | Minimum gingival collar height (mm) | 4.00 | | | | | | | | | | | Maximum gingival collar height (mm) | 5.00 | | | | | | | | | | | Minimum gingival collar (Ø) | 4.00 | | | | | | | | | | | Maximum gingival collar (Ø) | 9.50, 11.50 | | | | | | | | | | | Minimum post height (mm) | 4.00 | | | | | | | | | | | Maximum post height (mm) | 6.00 | | | | | | | | Abutment Screw | Description | The Abutment Screw is used for securing the abutment to the endosseous implant. | | | | | | | | | | | | | Material | Dimension (Diameter & Total Length) | Ti-6Al-4V ELI of ASTM F136-13 | | | | $\text{\O} 2.5 \text{ x } 5.1 \text{ mm}$ | {7}------------------------------------------------ # 6. Indication for use The ARi ExCon Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: - Delayed loading - Immediate loading when good primary stability is achieved and with appropriate occlusal loading. For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture. {8}------------------------------------------------ # 7. Basis for Substantial Equivalence D1 The ARi ExCon Implant System are substantially equivalent to the predicate for use, technical characteristic and function. They are made of the same material and have similar design. The subject of the subject device slightly differ from the predicate device however it is very minor not affecting substantial equivalence. Based on the technological characteristic comparison tables provided in this submission, we conclude that the subject device is substantially equivalent to the predicate device. # TABLE 1 - TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE ## ARi ExCon Implant #### Dimensions of the implants (Subject, Predicate and Reference devices) (A) ARi ExCon Implant – Subject device (B) External Hex – Predical – Ref. 1 (D) Straumann TLX – Ref. 2 (E) MegaSen Implants – Ref. 4 Image /page/8/Figure/7 description: The image shows five different types of dental implants, labeled A through E. Each implant has a different design and is labeled with its name: A. ARi ExCon Implant, B. External Hex, C. Noris - Cortical, D. Straumann TLX, and E. MegaGen Implants (BLUEDIAMOND). Each implant has dimensions labeled as D1, L1, L2, L3-L2, and L2-L1. | | Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Reference Device 4 | Reference Device 5 | Manufacturer | MegaGen Implant Co., Ltd. | Southern Implants (Pty) Ltd. | Noris Medical LTD | Institut Straumann AG | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510k | K231967 | K163634 | K210852 | K200586 | K203554 | K182448 | K122231 | Indication for use | The ARi ExCon Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: - Delayed loading - Immediate loading when good primary stability is achieved and with appropriate occlusal loading. | Southern Implants' External Hex Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Southern Implants' External Hex Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved. | Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one- stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | Straumann TLX Implants are suitable for endosteal implantation in the upper and lower jaws and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. TLX Implants can be placed with immediate function on single-tooth and multi- unit restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components. | The AnyOne External Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. | The BLUEDIAMOND IMPLNAT System is intended to be surgically placed in the maxillary or mandibular molar arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in chewing function in the following situations and with the clinical protocols: - Delayed loading - Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region. | The XPEED AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore patients chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. | | Device Name (Compatible Implant System) | ARi ExCon Implant For ARi ExCon Implant System | External Hex Implants For External Hex Implants | Noris Medical Dental Implants For Noris Medical Dental Implants System - Cortical | Straumann TLX Straumann TLX Implant System - TLX S | AnyOne External Fixture For AnyOne External Implant System | BLUEDIAMOND IMPLANT For BLUEDIAMOND IMPLANT System | XPEED AnyRidge Internal Fixture For XPEED AnyRidge Internal Implant System | Design | Image: MegaGen Implant | Image: Southern Implants | Image: Noris Medical LTD | Image: Institut Straumann AG | Image: MegaGen Implant | Image: MegaGen Implant | Image: MegaGen Implant | | Widest Thread Diameter (D1) (Ø) & Total Length (L3) (mm) | · Normal Thread Ø 3.8 × 11.0, 13.0, 15.0 Ø 4.3 × 11.0, 13.0, 15.0 Ø 4.8 × 11.0, 13.0, 15.0 Ø 5.3 × 11.0, 13.0, 15.0 | Ø3.25 × 8.5, 10.0, 11.5, 13.0, 15.0, 18.0 | Ø4.0 X 11.5, 13.0, 16.0, 18.0, 20.0 Ø5.0 X 11.5, 13.0, 16.0 Ø6.0 X 11.5, 13.0, 16.0 | Ø3.75 X 6.0, 8.0, 10.0, 12.0, 14.0, 16.0, 18.0 Ø4.0 X 6.0, 8.0, 10.0, 12.0, 14.0, 16.0, 18.0 Ø4.5 X 6.0, 8.0, 10.0, 12.0, 14.0, 16.0, 18.0 Ø5.0 X 6.0, 8.0, 10.0, 12.0, 14.0, 16.0, 18.0 Ø5.5 X 6.0, 8.0, 10.0, 12.0 Ø6.5 X 6.0, 8.0, 10.0, 12.0 | Ø3.9 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 Ø4.3 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 Ø4.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 Ø5.3 x 7.0, 8.0, 9.5, 11.0, | · Normal thread Ø3.6 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 Ø4.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 Ø4.4 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 Ø4.7 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 Ø5.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 | · Normal thread Ø4.0 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 Ø4.4 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 Ø4.9 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 Ø5.4 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 Ø5.9 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 | | | | | | | | | | | Ø 4.0 × 6.0, 8.5, 10.0, 11.5, 13.0, 15.0, 18.0, 20.0 | | | | | | | | | | | | | | | | | · Deep Thread Ø 4.3 × 11.0, 13.0, 15.0 Ø 4.8 × 11.0, 13.0, 15.0 Ø 5.3 × 11.0, 13.0, 15.0 | Ø4.0 x 6.0, 8.5, 10.0, 11.5, 13.0, 15.0 Ø4.7x 10.0, 11.5, 13.0, 15.0, 18.0 Ø5.0 x 6.0, 8.5, 10.0, 11.5, 13.0, 15.0 | | | | | | | | | | | | | | {9}------------------------------------------------ {10}------------------------------------------------ | | Ø 5.8 x 11.0, 13.0, 15.0 | 11.5, 13.0, 15.0, 18.0 Ø 5.7 x 10.0, 11.5, 13.0, 15.0, 18.0 Ø 6.0 x 7.0, 8.5, 10.0, 11.5, 13.0, 15.0 | | | 12.5, 14.5 Ø6.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 | 12.2, 14.2, 17.2 • Deep thread Ø4.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 Ø4.4 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 Ø4.8 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 Ø5.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 Ø5.5 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 | 14.2, 17.2 • Deep thread Ø6.4 X 7.9, 9.4, 10.9, 12.4, 14.4 Ø6.9 X 7.9, 9.4, 10.9, 12.4, 14.4 Ø7.4 X 7.9, 9.4, 10.9, 12.4, 14.4 Ø7.9 X 7.9, 9.4, 10.9, 12.4, 14.4 Ø8.4 X 7.9, 9.4, 10.9, 12.4, 14.4 | |-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Threaded Length (mm) (L1) | For all diameters: 7.0, 9.0 | Unknown | For Ø4.0: 6.8, 8.0, 10.0, 11.0, 12.5 For Ø5.0: 6.8, 8.0, 10.0 For Ø6.0: 6.8, 8.0, 10.0 | For Ø3.75, 4.5: 7.0, 8.3, 10.3, 12.3, 14.0, 16.0 For Ø5.5: 7.0, 8.3, 10…