MegaGen Dental Implant Abutment

K242030 · Megagen Implant Co., Ltd. · NHA · Jan 13, 2025 · Dental

Device Facts

Record IDK242030
Device NameMegaGen Dental Implant Abutment
ApplicantMegagen Implant Co., Ltd.
Product CodeNHA · Dental
Decision DateJan 13, 2025
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3630
Device ClassClass 2
AttributesTherapeutic

Intended Use

MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular 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. 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

Dental implant abutments; interface between endosseous dental implants and final prosthetic restorations (crowns, bridges, overdentures). Components include Healing Abutments, Temporary Cylinders, EZ Post Abutments/Cylinders, CCM Abutments, Gold Abutments, Octa Abutments, ZrGEN Abutments, TiGEN Abutments, AXA Abutments, and Abutment Screws. Inputs: patient-specific anatomical data for digitally designed abutments; physical implant fixture connection. Operation: surgical placement of abutment into implant fixture; prosthetic restoration secured via screw or cement. Used in dental clinics by dentists. Outputs: prosthetic support structure. Benefits: restoration of chewing function. Digitally designed abutments (TiGEN/ZrGEN) manufactured at validated milling centers. Some components (Healing Abutment) provided sterile; others (Temporary Cylinder, EZ Post, CCM, Gold, Octa, ZrGEN, TiGEN, AXA) provided non-sterile for user sterilization. Materials include Ti-6Al-4V ELI, Co-Cr-Mo alloy, gold alloy, POM (Delrin).

Clinical Evidence

No clinical data. Evidence consists of bench testing including biocompatibility (ISO 10993-1), sterilization validation (ISO 11137, ISO 17665-1, 2), shelf-life testing (ASTM F1980), endotoxin testing (USP 39 <85>), performance testing (ISO 14801), and MR compatibility assessment per FDA guidance.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136-13), Co-Cr-Mo alloy, gold alloy, POM (Delrin 100P NC010). Connection: Internal/External Hex, Internal Conical, Internal Octa. Energy: None (mechanical). Connectivity: None. Sterilization: Gamma (Healing Abutment) or user-performed steam sterilization. Form factor: Various abutment geometries for dental restoration support.

Indications for Use

Indicated for partially or fully edentulous individuals requiring prosthetic support for dental restorations (crowns, bridges, overdentures) in maxillary or mandibular areas to restore chewing function.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. January 13, 2025 MegaGen Implant Co., Ltd. Back Kyung-Hee Official Correspondent 45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun Daegu, 42921 REPUBLIC OF KOREA Re: K242030 Trade/Device Name: MegaGen Dental Implant Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 12, 2024 Received: December 12, 2024 Dear Back Kyung-Hee: 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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 Submission Number (if known) K242030 Device Name MegaGen Dental Implant Abutment Indications for Use (Describe) MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular 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. 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) 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}------------------------------------------------ ## 510(k) Summary For MegaGen Dental Implant Abutment (K242030) This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR Part 807.92. Date: January 08, 2025 ### 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: +82-53-247-2254 Email: ra9@imegagen.com #### 3. Device | • Trade Name: | MegaGen Dental Implant Abutment | |--------------------------------|------------------------------------| | • Common Name: | Endosseous Dental Implant Abutment | | • Classification Name: | Endosseous dental implant abutment | | • Classification Product Code: | NHA | | • Classification regulation: | Class II, 21 CFR 872.3630 | #### 4. Predicate Device - . Primary Predicate Device: K233450 MegaGen Dental Implant Abutment #### . Reference Devices: K110955 AnyRidge Internal Implant System K123988 AnyOne Internal Implant System K182448 BLUEDIAMOND IMPLANT System K203554 AnyOne External Implant System K203808 Multi-unit Abutment System K230618 MegaGen Dental Implant Systems Portfolio - MR Conditional K231967 ARi ExCon Implant System K220562 TiGEN, ZrGEN, Scan Healing Abutment {5}------------------------------------------------ #### 5. Description #### Healing Abutment . The Healing Abutment helps to form suitable emergence profile during . It is used for non-submerged type surgery or for two-stage surgery. It is made of Ti-6AI-4V-ELI and offered in machined surface. The Healing Abutment is sterilized using irradiation during manufacturing process and intended for single use. The dimensions of Healing Abutment are follows: | Device | Component | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Healing<br>Abutment | XPEED AnyRidge Internal Implant System<br>$ \varnothing $ 4.2, 5.2, 6.2, 7.2 x 13.4, 14.4 mm<br>AnyOne Internal Implant System<br>$ \varnothing $ 4.2, 4.7, 5.7, 6.7 x 14.2, 15.2 mm | The Healing Abutment is compatible with following MegaGen Implants cleared under: | Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) | |-----------------------------------|-------------------------------------------|------------------------------------|-------------------------------|-----------------------------------------------------|-----------------------------------------------------| | MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant System | XPEED AnyRidge<br>Internal Fixture | K122231<br>K123870<br>K140091 | Internal Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 | | AnyOne Internal Implant<br>System | AnyOne Internal<br>Fixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,<br>7.3, 7.8, 8.3 | | #### Temporary Cylinder The Temporary Cylinder is used in conjunction with Abutment to provisional restoration. It is connected to the Abutment with Cylinder Screw. It is made of POM and offered in machined surface. The Temporary Cylinder is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use. #### The dimensions of Temporary Cylinder are follows: | Device | Component | |-----------------------|-----------------------------| | Temporary<br>Cylinder | Common<br>$Ø$ 5.0 x 10.0 mm | #### I EZ Post Abutment The EZ Post Abutment is used in conjunction with fixture to provide support for cement and screw retained type final prosthesis. It is made of Ti-6AI-4V-ELI, and offered in anodizing. The EZ Post Abutment is supplied non-sterilized by the user according to the IFU and intended for single use. The dimensions of EZ Post Abutment are follows: | Device | Component | |---------------------|---------------------------------------------------------------------------------------| | EZ Post<br>Abutment | AnyOne Internal Implant System<br>$Ø$ 4.5, 5.5, 6.5 x 11.2, 12.2, 13.2, 14.2, 15.2 mm | The E7 Post Abutment is compatible with following MegaGen Implants cleared under: | Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) | |---------------------------------|-----------------------------------|----------------------------|------------------|--------------|-----------------------------------------------------| | MegaGen<br>Implant Co.,<br>Ltd. | AnyOne Internal<br>Implant System | AnyOne Internal<br>Fixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,<br>7.3, 7.8, 8.3 | #### I EZ Post Cylinder The EZ Post Cylinder is used in conjunction with Multi-unit Abutment to provide support cement and screw type final prosthesis. It is connected to the Abutment with Cylinder Screw. It is made of Ti-6AI-4V-ELI, and offered in machined surface. The EZ Post Cylinder is supplied non-sterilized by the user according to the IFU and intended for single use. {6}------------------------------------------------ The dimensions of EZ Post Cylinder are follows: | Device | Component | |------------------|---------------------------------------------| | EZ Post Cylinder | Common<br>$\(\phi\)$ 4.8 x 4.5, 6.0, 7.0 mm | #### CCM Abutment The CCM Abutment is used in conjunction with fixture and connected to the Fixture with Multi Post Screw. The CCM Abutment is available to cast with non-precious metal alloys (Co-Cr-Mo alloy). The CCM Cuff connected with Fixture is made of CO-Cr-Mo alloy, and CCM Sleeve covered with final prosthesis is made of plastic (POM), which has grooved surface to allow better retention of resin or wax. The plastic part will be removed after casting. The CCM Abutment is not is the final prosthesis. The CCM Abutment is supplied non-sterilized by the user according to the IFU and intended for single use. The dimensions of CCM Abutment are follows: | Device | Component | |--------------|-----------------------------------------------------------| | CCM Abutment | XPEED AnyRidge Internal Implant System<br>Ø 3.8 x 14.7 mm | The CCM Abutment is compatible with following MegaGen Implants cleared under: | Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) | |---------------------------------|----------------------------------------------|------------------------------------|-------------------------------|--------------|-----------------------------------------------------| | MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant<br>System | XPEED AnyRidge<br>Internal Fixture | K122231<br>K123870<br>K140091 | Internal Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 | #### Gold Abutment The Gold Abutment is used in conjunction with fixture and connected to the Fixture with Multi Post Screw. The Gold Abutment is available to cast with precious metal alloys (Gold Cuff connected with Fixture is made of gold alloy, and Gold Sleeve covered with final prosthesis is made of plastic (POM), which has grooved surface to allow better retention of resin or wax. The plastic part will be removed after casting. The Gold Abutment is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use. The dimensions of Gold Abutment are follows: | Device | Component | |---------------|-----------------------------------------------------------| | Gold Abutment | XPEED AnyRidge Internal Implant System<br>Ø 3.8 x 14.7 mm | The Gold Abutment is compatible with following MegaGen Implants cleared under: | Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) | |---------------------------------|----------------------------------------------|------------------------------------|-------------------------------|--------------|-----------------------------------------------------| | MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant<br>System | XPEED AnyRidge<br>Internal Fixture | K122231<br>K123870<br>K140091 | Internal Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 | #### Octa Abutment The Octa Abutment is used for fabricating screw-retained prosthesis. The lower part has a male screw to place into the fixture, and the top part has a female screw to connect Cylinders or ZrGEN Abutment of Octa type with Abutment Screw to fabricate temporary or final prosthesis. It is made of Ti-6AI-4V-ELJ, and offered in anodizing. The Octa Abutment is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use. The dimensions of Octa Abutment are follows: | Device | Component | |---------------|-------------------------------------------------------------------------------------------| | Octa Abutment | XPEED AnyRidge Internal Implant System<br>Ø 3.8, 4.8, 5.8 x 8.0, 9.0, 10.0, 11.0, 12.0 mm | The Octa Abutment is compatible with following MegaGen Implants cleared under: {7}------------------------------------------------ | Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) | |---------------------------------|----------------------------------------------|------------------------------------|-------------------------------|--------------|-----------------------------------------------------| | MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant<br>System | XPEED AnyRidge<br>Internal Fixture | K122231<br>K123870<br>K140091 | Internal Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 | #### ' ZrGEN Abutment The ZrGEN Abutment is a two-piece abutment composed of the stock titanium base cemented together with the zirconia tophalf to complete the finished device. It is made of Ti-6Al-4V ELI. It is provided with abutment screw. All ZrGEN Abutment is provided non-sterile. Therefore, the ZrGEN Abutment must be sterilized by users prior to use. The dimensions of ZrGEN Abutment are follows: | Device | Component | |-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | ZrGEN<br>Abutment | XPEED AnyRidge Internal Implant System<br>Standard Type - Ø 4.0, 4.4 x 7.7, 8.6, 9.2, 10.1, 11.1, 11.2, 11.6, 12.1, 12.6, 13.3, 14.6 mm | | | AnyOne Internal Implant System<br>Standard Type - Ø 4.0, 4.4 x 8.0, 8.9, 9.5, 10.4, 11.4, 11.5, 11.9, 12.4, 12.9, 13.9, 14.9 mm | | | ST Internal Implant System<br>C-Type - Ø 4.3, 5.5 x 8.0, 8.15, 8.5, 8.65, 9.5, 9.65 mm | | | Standard Type - Ø 4.0, 4.4 x 7.8, 7.9, 8.0, 8.7, 8.8, 9.3, 9.4, 10.2, 10.3, 11.3, 11.4, 11.7, 11.8, 12.2, 12.3, 12.7, 12.8, 13.7,<br>13.8, 14.7, 14.8 mm | | | Common<br>Octa Type - Ø 5.0, 5.5, 6.5 x 5.8, 6.8, 8.8 mm | #### The allowable ranges of design parameters are follows: | Titanium base | Minimum wall thickness (mm) | 0.123, 0.3225, 0.5 | | |---------------|-----------------------------|-------------------------------------|--| | | Maximum angulation (°) | 0 | | | | Minimum gingival collar (Ø) | 3.00, 3.15, 3.40, 4.05, 4.25, 5.25, | | | | Maximum gingival collar (Ø) | 4.00, 4.30, 4.40, 5.00, 5.50, 6.50 | | | | Minimum post height (mm) * | 3.20, 3.70, 4.70, 6.70 | | | | Maximum post height (mm) * | 4.50, 4.70, 5.00, 6.00, 8.00 | | * Post height for single-unit restoration is defined as the cementable post measured above the gingival collar of the final abutment design. #### The allowable ranges of design parameters for Zirconia top-half after CAD/CAM patient-matching are follows: | Zirconia top-half | Minimum wall thickness (mm) | 0.5 | |-------------------|-------------------------------------|-----| | | Maximum angulation (°) | 0 | | | 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 | The ZrGEN Abutment is compatible with following MegaGen Implants cleared under: | Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) | |---------------------------------|----------------------------------------------|------------------------------------|-------------------------------|--------------|-----------------------------------------------------| | MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant<br>System | XPEED AnyRidge<br>Internal Fixture | K122231<br>K123870<br>K140091 | Internal Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 | | | AnyOne Internal<br>Implant System | AnyOne Internal<br>Fixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,<br>7.3, 7.8, 8.3 | | | ST Internal Implant<br>System | ST Internal Fixture | K192347 | Internal Hex | 3.7, 4.2, 4.7, 5.2, 6.2, 7.2 | {8}------------------------------------------------ #### TiGEN Abutment ■ The TiGEN Abutment is machined with the final prosthetic in accordance with the intraoral structure. It is machined by using dental CAD/CAM technology in accordance with customized patient's information in MegaGen-validated milling center. The TiGEN Abutment is made of Ti-6Al-4V ELI. And It is provided with abutment is provided non-sterile. The milled TiGEN Abutment must be sterilized by users prior to use. | Device | Component | |-------------------|---------------------------------------------------------------------| | TIGEN<br>Abutment | ST Internal Implant System<br>Ø 10.0, 12.0 x 28.55, 28.70, 28.85 mm | The allowable ranges of design parameters after CAD/CAM patient-matching are follows: | Standard Type | Minimum wall thickness (mm) | 0.25 | |---------------|-------------------------------------|-------------| | | Maximum angulation (°) | 30 | | | Minimum gingival collar (ø) | 4.00 | | | Maximum gingival collar (ø) | 9.50, 11.50 | | | Minimum Gingival collar height (mm) | 0.50 | | | Maximum Gingival collar height (mm) | 5.00 | | | Minimum post height (mm) * | 4.00 | | | Maximum post height (mm) * | 6.00 | * Post height for single-unit restoration is defined as the cementable post measured above the final abutment design. #### The TiGEN Abutment is compatible with following MegaGen Implants cleared under: | Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) | |---------------------------------|-------------------------------|---------------------|------------------|--------------|------------------------------| | MegaGen<br>Implant Co.,<br>Ltd. | ST Internal Implant<br>System | ST Internal Fixture | K192347 | Internal Hex | 3.7, 4.2, 4.7, 5.2, 6.2, 7.2 | #### - AXA Abutment - 1) Straight Type The AXA Abutment of straight type is a one-piece type. The AXA Abutment is intended only for multi-unit loaded restoration. It is made of Ti-6AI-4V-ELI and offered in anodizing gold. The AXA Abutment is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use. - 2) Angled Type The AXA Abutment of angled type is two-piece type. The AXA Abutment is intended only for multi-unit loaded restoration. It is made of Ti-6AI-4V-ELI and offered in anodizing gold. They are available in 12°, 20° and 30° angles, and offers one type (Hex type). The AXA Abutment is supplied non-sterilized by the user according to the IFU and intended for single use. #### The dimensions of AXA Abutment are follows: | Device | Component | |--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AXA Abutment | ARi ExCon Implant System<br>Straight Type - Ø 4.2 x 7.5, 8.5, 9.5, 10.5, 11.5 mm<br>Angled Type - Ø 4.2, 4.75 x 5.865, 6.349, 6.65, 6.865, 7.349, 7.65, 7.865, 8.349, 8.65, 8.865, 9.349, 9.65 mm x 12°, 20°, 30° | #### The AXA Abutment is compatible with following MegaGen Implants cleared under: | Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) | |---------------------------------|------------------------------|-------------------|------------------|--------------|-------------------------| | MegaGen<br>Implant Co.,<br>Ltd. | ARi ExCon Implant<br>System | ARi ExCon Implant | K231967 | External Hex | 3.8, 4.3, 4.8, 5.3, 5.8 | {9}------------------------------------------------ #### · Abutment Screw The Abutment Screw is used for securing the abutment to the endosseous implant. It is made of Ti-6AI-4V-ELl and offered in anodizing gold and machined surface. The Abutment Screw is supplied non-sterilized by the user according to the IFU and intended for single use. | Device | Component | |-------------------|------------------------------------------------------------------------------------------------------| | Abutment<br>Screw | ARi ExCon Implant System<br>$\varnothing$ 2.2, 2.25, 2.3, 2.6 x 4.7, 5.2, 6.2, 7.2, 8.2, 9.2, 9.9 mm | #### The dimensions of Abutment Screw are follows: #### 6. Indications for use MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular 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. All digitally designed abutments for use with TiGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture #### 7. Basis for Substantial Equivalence The MegaGen Dental Implant Abutment is substantially equivalent to the predicate device in terms of indication for use, technical characteristic and function. They are material and have similar design. The size range of the subject of the subject device slightly differ from the predicate device however it is very minor not affecting substantial equivalence. Based on the comparison charts below and test results provided in this submission, we conclude that the subject device is substantially equivalent to the predicate device. #### (1) Healing Abutment | | Subject Device | Reference Device 1 | Reference Device 2 | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | K242030 | K110955 | K182448 | | Device Name | Healing Abutment | Healing Abutment | Healing Abutment | | Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | | Indications for<br>Use Statement | MegaGen Dental Implant Abutment is<br>intended to be surgically placed in the<br>maxillary or mandibular areas for the<br>purpose providing prosthetic support for<br>dental restorations (Crown, bridges, and<br>overdentures) in partially or fully<br>edentulous individuals. It is used to<br>restore a patient's chewing function.<br>All digitally designed abutments for use<br>with TiGEN Abutment and ZrGEN<br>Abutment are intended to be sent to a<br>MegaGen validated milling center for<br>manufacture | The AnyRidge Internal Implant System is<br>intended to be surgically placed in the<br>maxillary or mandibular molar areas for<br>the purpose providing prosthetic support<br>for dental restorations (Crown, bridges,<br>and overdentures) in partially or fully<br>edentulous individuals. It is used to<br>restore a patient's chewing function.<br>Smaller implants (less than Ø6.0 mm) are<br>dedicated for immediate loading when<br>good primary stability is achieved and<br>with appropriate occlusal loading. Larger<br>implants are dedicated for the molar<br>region and are indicated for delayed<br>loading. | The BLUEDIAMOND IMPLANT System is<br>intended to be surgically placed in the<br>maxillary or mandibular molar areas for<br>the purpose providing prosthetic support<br>for dental restorations (Crown, bridges,<br>and overdentures) in partially or fully<br>edentulous individuals. It is used to<br>restore a patient's chewing function in the<br>following situation and with the clinical<br>protocols:<br>- Immediate loading when good primary<br>stability is achieved and with appropriate<br>occlusal loading. | | Design | Image: Subject Device Design | Image: Reference Device 1 Design | Image: Reference Device 2 Design | | Diameter ( $Ø$ ,<br>mm) | 4.2, 4.7, 5.2, 5.7, 6.2, 6.7, 7.2 | 4.2, 5.2, 6.2, 7.2, 10.0 | 3.2, 4.2, 5.2, 6.2 | {10}------------------------------------------------ | Gingival Height<br>(mm) | 7.8, 8.5, 8.8, 9.5 | 3.5, 4.5, 5.5, 6.5, 7.5 | 2.5, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5 | |------------------------------------|--------------------------------------------------------------------------|----------------------------------|----------------------------------------| | Total Length<br>(mm) | 13.4 ~ 15.2 | 8.4 ~ 14.4 | 8.6 ~ 15.6 | | Connection<br>Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection | | Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | | Surface<br>Treatment | Anodizing | Machined | Anodizing | | Single Use | Yes | Yes | Yes | | Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | | Shelf-life | 5 years | 5 years | 5 years | | Compatible<br>Implant<br>System | XPEED AnyRidge Internal Implant System<br>AnyOne Internal Implant System | AnyRidge Internal Implant System | BLUEDIAMOND IMPLANT System | | Substantial Equivalence Discussion | | | | #### 1. Similarities The subject device has the same characteristic for the followings compared to the prior cleared Reference devices. - Indications for Use, Design, Diameter, Gingival Height, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Shelf Life #### 2. Difference There are no differences with the Reference devices. #### 3. Discussion The proposed Healing Abutment and reference devices have common in all items in the comparison, and can be considered practically equivalent. {11}------------------------------------------------ ## (2) Temporary Cylinder | | Subject Device | Predicate Device | Reference Device | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | K242030 | K233450 | K231967 | | Device Name | Temporary Cylinder | Temporary Cylinder | Temporary Abutment | | Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | | Indications<br>for Use<br>Statement | MegaGen Dental Implant Abutment is<br>intended to be surgically placed in the<br>maxillary or mandibular areas for the<br>purpose providing prosthetic support for<br>dental restorations (Crown, bridges, and<br>overdentures) in partially or fully<br>edentulous individuals. It is used to<br>restore a patient's chewing function.<br>All digitally designed abutments for use<br>with TIGEN Abutment and ZrGEN<br>Abutment are intended to be sent to a<br>MegaGen validated milling center for<br>manufacture | The MegaGen Dental Implant Abutment is<br>intended to be surgically placed in the<br>maxillary or mandibular areas for the<br>purpose providing prosthetic support for<br>dental restorations (Crown, bridges, and<br>overdentures) in partially or fully<br>edentulous individuals. It is used to restore<br>a patient's chewing function.<br>All digitally designed abutments for use with<br>ZrGEN Abutment are intended to be sent to<br>a MegaGen validated milling center for<br>manufacture | The ARi ExCon Implant System is<br>intended to be surgically placed in the<br>maxillary or mandibular molar areas for<br>the purpose providing prosthetic<br>support for dental restorations (Crown,<br>bridges, and overdentures) in partially<br>or fully edentulous individuals. It is<br>used to restore a patient's chewing<br>function in the following situations and<br>with the clinical protocols:<br>- Delayed loading<br>- Immediate loading when good<br>primary stability is achieved and with<br>appropriate occlusal loading. | | Design | Image: Subject Device Design | Image: Predicate Device Design | Image: Reference Device Design | | Diameter (Ø,<br>mm) | 5.0 | 4.8, 4.9, 5.7 | 3.5, 4.0, 4.5, 5.0, 6.0 | | Gingival<br>Height (mm) | 2.3, 4.1, 6.1 | 3.0 | 2.0 | | Post Height<br>(mm) | 3.9, 6.9, 7.7 | 8.5 | 8.0, 10.0, 12.0 | | Total Length<br>(mm) | 10.0 | 12.0 | 10.0 ~ 14.0 | | Angulation (°) | Straight | Straight | Straight | | Connection<br>Interface | Internal Non-Hex | Internal Non-Hex | External Hex | | Material | POM (Delrin 100P NC010) | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13),<br>POM (Delrin 100P NC010) | | Surface<br>Treatment | Machined | Machined | Machined, Anodizing | | Single Use | Yes | Yes | Yes | | Sterilization | Non-sterile | Non-sterile | Non-sterile | | Compatible<br>Implant<br>System | Common | XPEED AnyRidge Internal Implant System<br>BLUEDIAMOND IMPLANT System | ARi ExCon Implant System | | Substantial Equivalence Discussion | | | | #### 1. Similarities The subject device has the same characteristic for the followings compared to the prior cleared Predicate device and/or reference device. - Indications for Use, Design, Diameter, Total length, Angulation, Connection Interface, Surface Treatment, Material, Single Use and Sterilization #### 2. Differences The subject device has the different characteristic for the fredicate device and/or reference device. - Gingival Height The Gingival Height of the subject device is slightly different with the predicate device. Some dimension (2.3mm) are within the range of the predicate device and reference device. Other dimensions (4.1mm and 6.1mm) are slightly longer than the predicate device. It does not cause a matter in substantial equivalence since the total length is within the range of the predicate and reference devices, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition. - Post Height {12}------------------------------------------------ The Post Height of the subject device is slightly different with the predicate device. But, the size can be possible to operate more precise treatment to meet each patient's condition. Therefore, it does not cause a matter in substantial equivalence. #### 3. Discussion The proposed Temporary Cylinder and predicate device have common in all items in the comparison chart except the Gingival Height and Post Height. These differences are not affect device's substantial equivalence. Also, the subject device is intended for temporary use. On the basis of the discussion above, it is concluded that the substantially equivalent to the Reference devices. {13}------------------------------------------------ #### (3) EZ Post Abutment | | Subject Device | Predicate Device | Reference Device | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------…
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