(186 days)
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
The MegaGen Dental Implant Abutment includes several components: Healing Abutment, Temporary Cylinder, EZ Post Abutment, EZ Post Cylinder, CCM Abutment, Gold Abutment, Octa Abutment, ZrGEN Abutment, TiGEN Abutment, AXA Abutment (Straight and Angled Types), and Abutment Screw. These components are made of materials such as Ti-6Al-4V-ELI, POM, Co-Cr-Mo alloy, and gold alloy, and are offered with machined or anodized surfaces. Some components are supplied sterile, while others are non-sterile and require sterilization by the user. They are intended for single use. The device provides prosthetic support for dental restorations on endosseous dental implants.
The provided text is a 510(k) summary for the MegaGen Dental Implant Abutment, seeking clearance based on substantial equivalence to predicate devices. It does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance, diagnostic accuracy, or effectiveness with human readers.
Instead, the document details a comparison of the subject device (MegaGen Dental Implant Abutment) with various predicate and reference devices, focusing on technical characteristics, materials, and design. The "acceptance criteria" referred to in the document are primarily related to meeting the characteristics of the predicate devices and demonstrating that any differences do not affect the fundamental function or safety of the device. The "study" that "proves" the device meets these criteria is a non-clinical testing summary, including biocompatibility, sterilization validation, accelerated shelf-life, pyrogen/endotoxin testing, performance testing (ISO 14801), and MR compatibility.
Therefore, many of the requested fields cannot be answered directly from the provided text as they pertain to clinical or diagnostic performance studies involving human subjects or AI algorithms, which are not described here.
Here's a breakdown of the information that can be extracted, and where the requested information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance for each component in a consolidated manner. Instead, it discusses "similarities" and "differences" compared to predicate/reference devices, and states that "test results met the pre-set criteria" for performance testing (ISO 14801) and that biocompatibility and sterilization have been validated.
Below is a summarized representation of the comparison for one component (Healing Abutment) as an example, to illustrate the type of comparison presented in the document. The "acceptance criteria" are implied by the characteristics of the predicate/reference devices, and "reported device performance" refers to the subject device's characteristics or the outcome of non-clinical tests.
Example for Healing Abutment:
| Acceptance Criteria (Implied by Predicate/Reference Devices) | Reported Device Performance (Subject Device) |
|---|---|
| Indications for Use: Prosthetic support for dental restorations in partially or fully edentulous individuals. | Met: Same indications for use. |
| Design: Similar to predicate. | Met: Similar design. |
| Diameter (Ø, mm): Ranges like 4.2, 5.2, 6.2, 7.2 | Met: 4.2, 4.7, 5.2, 5.7, 6.2, 6.7, 7.2 (Expanded range, but similar characteristics) |
| Gingival Height (mm): Ranges like 3.5, 4.5, 5.5, 6.5, 7.5 | Met: 7.8, 8.5, 8.8, 9.5 (Different ranges, but considered practically equivalent) |
| Total Length (mm): Ranges like 8.4 ~ 14.4 | Met: 13.4 ~ 15.2 (Different range, but considered practically equivalent) |
| Connection Interface: Internal Conical Connection | Met: Internal Conical Connection |
| Material: Ti-6Al-4V ELI (ASTM F136-13) | Met: Ti-6Al-4V ELI (ASTM F136-13) |
| Surface Treatment: Anodizing or Machined | Met: Anodizing |
| Single Use: Yes | Met: Yes |
| Sterilization: Gamma sterilization | Met: Gamma sterilization (validated per ISO 11137) |
| Shelf-life: 5 years | Met: 5 years (validated per ASTM F1980) |
| Biocompatibility: Compliant with ISO 10993-1 | Met: Evaluated per ISO 10993-1 (leveraged from prior cleared devices) |
| Performance Testing (Fatigue): Meets ISO 14801 and guidance document recommendations | Met: Test results met pre-set criteria. |
| MR Compatibility: MR Conditional | Met: Assessed not to configure a new worst case; leveraged K230618. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified for any clinical or diagnostic evaluation. The evaluations are primarily non-clinical. For performance testing (ISO 14801), the sample size for individual tests like fatigue is not mentioned within this summary, only that tests were performed.
- Data Provenance: Not applicable in the context of clinical/diagnostic data. For non-clinical tests like biocompatibility and sterilization, previous 510(k) submissions (e.g., K110955, K123988, K210161, K220562, E220672, K230618) from MegaGen Implant Co., Ltd. are leveraged. The tests were performed according to international standards (ISO, ASTM, USP).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this type of medical device (dental implant abutment) is established by engineering specifications, material properties, and performance under rigorous bench testing conditions, compared to predicate devices. There is no mention of expert consensus for diagnostic ground truth.
4. Adjudication method for the test set
Not applicable. No expert adjudication process for diagnostic imaging or clinical outcomes is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a dental implant abutment, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for demonstrating substantial equivalence is based on:
- Comparison to legally marketed predicate devices (their established safety and effectiveness).
- Compliance with recognized international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11137 for sterilization, ASTM F1980 for shelf-life, ISO 14801 for performance/fatigue testing, and FDA guidance documents for MR compatibility).
- Confirmation through non-clinical bench testing that the device's physical and mechanical properties meet predefined criteria, demonstrating that any differences from predicate devices do not raise new questions of safety or effectiveness.
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This pertains to AI algorithms.
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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
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Indications for Use
Submission Number (if known)
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)
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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
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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 |
|---|---|
| HealingAbutment | XPEED AnyRidge Internal Implant System$ \varnothing $ 4.2, 5.2, 6.2, 7.2 x 13.4, 14.4 mmAnyOne Internal Implant System$ \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 ImplantSystem | Device Name | 510(k)Number | Connection | Diameter (mm) |
|---|---|---|---|---|---|
| MegaGenImplant Co.,Ltd. | XPEED AnyRidgeInternal Implant System | XPEED AnyRidgeInternal Fixture | K122231K123870K140091 | Internal Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,7.4, 7.9, 8.4 |
| AnyOne Internal ImplantSystem | AnyOne InternalFixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,7.3, 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 |
|---|---|
| TemporaryCylinder | Common$Ø$ 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 PostAbutment | AnyOne Internal Implant System$Ø$ 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 ImplantSystem | Device Name | 510(k)Number | Connection | Diameter (mm) |
|---|---|---|---|---|---|
| MegaGenImplant Co.,Ltd. | AnyOne InternalImplant System | AnyOne InternalFixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,7.3, 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.
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The dimensions of EZ Post Cylinder are follows:
| Device | Component |
|---|---|
| EZ Post Cylinder | Common$(\phi)$ 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 SystemØ 3.8 x 14.7 mm |
The CCM Abutment is compatible with following MegaGen Implants cleared under:
| Manufacturer | Compatible ImplantSystem | Device Name | 510(k)Number | Connection | Diameter (mm) |
|---|---|---|---|---|---|
| MegaGenImplant Co.,Ltd. | XPEED AnyRidgeInternal ImplantSystem | XPEED AnyRidgeInternal Fixture | K122231K123870K140091 | Internal Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,7.4, 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 SystemØ 3.8 x 14.7 mm |
The Gold Abutment is compatible with following MegaGen Implants cleared under:
| Manufacturer | Compatible ImplantSystem | Device Name | 510(k)Number | Connection | Diameter (mm) |
|---|---|---|---|---|---|
| MegaGenImplant Co.,Ltd. | XPEED AnyRidgeInternal ImplantSystem | XPEED AnyRidgeInternal Fixture | K122231K123870K140091 | Internal Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,7.4, 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 SystemØ 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:
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| Manufacturer | Compatible ImplantSystem | Device Name | 510(k)Number | Connection | Diameter (mm) |
|---|---|---|---|---|---|
| MegaGenImplant Co.,Ltd. | XPEED AnyRidgeInternal ImplantSystem | XPEED AnyRidgeInternal Fixture | K122231K123870K140091 | Internal Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,7.4, 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 |
|---|---|
| ZrGENAbutment | XPEED AnyRidge Internal Implant SystemStandard 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 SystemStandard 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 SystemC-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, 13.7,13.8, 14.7, 14.8 mm | |
| CommonOcta 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 ImplantSystem | Device Name | 510(k)Number | Connection | Diameter (mm) |
|---|---|---|---|---|---|
| MegaGenImplant Co.,Ltd. | XPEED AnyRidgeInternal ImplantSystem | XPEED AnyRidgeInternal Fixture | K122231K123870K140091 | Internal Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,7.4, 7.9, 8.4 |
| AnyOne InternalImplant System | AnyOne InternalFixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,7.3, 7.8, 8.3 | |
| ST Internal ImplantSystem | ST Internal Fixture | K192347 | Internal Hex | 3.7, 4.2, 4.7, 5.2, 6.2, 7.2 |
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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 |
|---|---|
| TIGENAbutment | ST Internal Implant SystemØ 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 ImplantSystem | Device Name | 510(k)Number | Connection | Diameter (mm) |
|---|---|---|---|---|---|
| MegaGenImplant Co.,Ltd. | ST Internal ImplantSystem | ST Internal Fixture | K192347 | Internal Hex | 3.7, 4.2, 4.7, 5.2, 6.2, 7.2 |
- AXA Abutment
-
- 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.
- Straight Type
-
- 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.
- Angled Type
The dimensions of AXA Abutment are follows:
| Device | Component |
|---|---|
| AXA Abutment | ARi ExCon Implant SystemStraight Type - Ø 4.2 x 7.5, 8.5, 9.5, 10.5, 11.5 mmAngled 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 ImplantSystem | Device Name | 510(k)Number | Connection | Diameter (mm) |
|---|---|---|---|---|---|
| MegaGenImplant Co.,Ltd. | ARi ExCon ImplantSystem | ARi ExCon Implant | K231967 | External Hex | 3.8, 4.3, 4.8, 5.3, 5.8 |
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· 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 |
|---|---|
| AbutmentScrew | ARi ExCon Implant System$\varnothing$ 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 forUse Statement | MegaGen Dental Implant Abutment isintended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.All digitally designed abutments for usewith TiGEN Abutment and ZrGENAbutment are intended to be sent to aMegaGen validated milling center formanufacture | The AnyRidge Internal Implant System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than Ø6.0 mm) arededicated for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading. Largerimplants are dedicated for the molarregion and are indicated for delayedloading. | The BLUEDIAMOND IMPLANT System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function in thefollowing situation and with the clinicalprotocols:- Immediate loading when good primarystability is achieved and with appropriateocclusal loading. |
| Design | Image: Subject Device Design | Image: Reference Device 1 Design | Image: Reference Device 2 Design |
| Diameter ( $Ø$ ,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 |
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| Gingival Height(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(mm) | 13.4 ~ 15.2 | 8.4 ~ 14.4 | 8.6 ~ 15.6 |
| ConnectionInterface | 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) |
| SurfaceTreatment | Anodizing | Machined | Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Shelf-life | 5 years | 5 years | 5 years |
| CompatibleImplantSystem | XPEED AnyRidge Internal Implant SystemAnyOne 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.
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(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. |
| Indicationsfor UseStatement | MegaGen Dental Implant Abutment isintended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.All digitally designed abutments for usewith TIGEN Abutment and ZrGENAbutment are intended to be sent to aMegaGen validated milling center formanufacture | The MegaGen Dental Implant Abutment isintended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used to restorea patient's chewing function.All digitally designed abutments for use withZrGEN Abutment are intended to be sent toa MegaGen validated milling center formanufacture | The ARi ExCon Implant System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prostheticsupport for dental restorations (Crown,bridges, and overdentures) in partiallyor fully edentulous individuals. It isused to restore a patient's chewingfunction in the following situations andwith the clinical protocols:- Delayed loading- Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. |
| Design | Image: Subject Device Design | Image: Predicate Device Design | Image: Reference Device Design |
| Diameter (Ø,mm) | 5.0 | 4.8, 4.9, 5.7 | 3.5, 4.0, 4.5, 5.0, 6.0 |
| GingivalHeight (mm) | 2.3, 4.1, 6.1 | 3.0 | 2.0 |
| Post Height(mm) | 3.9, 6.9, 7.7 | 8.5 | 8.0, 10.0, 12.0 |
| Total Length(mm) | 10.0 | 12.0 | 10.0 ~ 14.0 |
| Angulation (°) | Straight | Straight | Straight |
| ConnectionInterface | 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),POM (Delrin 100P NC010) |
| SurfaceTreatment | Machined | Machined | Machined, Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| CompatibleImplantSystem | Common | XPEED AnyRidge Internal Implant SystemBLUEDIAMOND 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 | |
|---|---|---|---|
| 510(k) No. | K242030 | K233450 | K110955 |
| Device Name | EZ Post Abutment | EZ Post Abutment | EZ Post Abutment |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | MegaGen Dental Implant Abutment isintended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.All digitally designed abutments for usewith TIGEN Abutment and ZrGENAbutment are intended to be sent to aMegaGen validated milling center formanufacture | The MegaGen Dental Implant Abutmentis intended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.All digitally designed abutments for usewith ZrGEN Abutment are intended to besent to a MegaGen validated millingcenter for manufacture | The AnyRidge Internal Implant Systemis intended to be surgically placed inthe maxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than Ø6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriate occlusalloading. Larger implants are dedicatedfor the molar region and are indicatedfor delayed loading. |
| Design | Image: design | Image: design | Image: design |
| Diameter (Ø, mm) | 4.5, 5.5, 6.5 | 4.0, 5.0, 6.0, 7.0 | 4.0, 5.0, 6.0, 7.0 |
| Gingival Height(mm) | 1.5, 2.5, 3.5, 4.5 | 0.8, 1.8, 2.8, 3.8, 4.8 | 1.8, 2.8, 3.8, 4.8 |
| Post Height(mm) | 7.0 | 4.0, 5.5, 7.0 | 5.5, 7.0 |
| Total Length(mm) | 11.2 ~ 15.2 | 6.15 ~ 13.15 | 7.85 ~ 16.35 |
| Angulation (°) | Straight | Straight | Straight |
| ConnectionInterface | Internal Hex, Internal Non-Hex | Internal Octa | Internal Hex, Internal Non-Hex |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) |
| SurfaceTreatment | Anodizing | Anodizing | Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| CompatibleImplantSystem | AnyOne Internal Implant System | BLUEDIAMOND IMPLANT System | AnyRidge Internal 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, Post Height, Connection Interface, Angulation, Material, Surface Treatment, Single Use and Sterilization
2. Differences
The subject device has the different characteristic for the fredicate device and/or reference device. - Diameter
The Diameter of the subject device is slightly different with the predicate device, but all of diameter lie within range of the predicate device and reference device.
- Gingival Height
The Gingival Height of the subject device is slightly different with the predicate device, but all of diameter lie within range of the predicate device and reference device.
{14}------------------------------------------------
3. Discussion
The proposed EZ Post Abutment and Predicate device have common in all items in the comparison chart except Diameter and Gingival Height. These differences are explained not affecting on device's fundamental functions and safety. Also, the proposed product is straight type abutment, the fatigue test was performed as a representative of the worst case model with angle. On the basis of the discussion above, it is concluded that the substantially equivalent to the predicate and reference devices.
{15}------------------------------------------------
(4) EZ Post Cylinder
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) No. | K242030 | K233450 |
| Device Name | EZ Post Cylinder | EZ Post Cylinder |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | MegaGen Dental Implant Abutment is intended to besurgically placed in the maxillary or mandibular areas for thepurpose providing prosthetic support for dental restorations(Crown, bridges, and overdentures) in partially or fullyedentulous individuals. It is used to restore a patient'schewing function.All digitally designed abutments for use with TiGEN Abutmentand ZrGEN Abutment are intended to be sent to a MegaGenvalidated milling center for manufacture | The MegaGen Dental Implant Abutment is intended to besurgically placed in the maxillary or mandibular areas for thepurpose providing prosthetic support for dental restorations(Crown, bridges, and overdentures) in partially or fullyedentulous individuals. It is used to restore a patient's chewingfunction.All digitally designed abutments for use with ZrGEN Abutmentare intended to be sent to a MegaGen validated milling centerfor manufacture |
| Design | Image: Design of subject device | Image: Design of predicate device |
| Diameter (Ø,mm) | 4.8 | 4.8, 4.9, 5.7 |
| Total Length(mm) | 4.5 ~ 7.0 | 4.2 ~ 9.0 |
| Angulation (°) | Straight | Straight |
| ConnectionInterface | Internal Non-Hex | Internal Non-Hex |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) |
| SurfaceTreatment | Machined | Machined, Anodizing |
| Single Use | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
| CompatibleImplantSystem | XPEED AnyRidge Internal Implant SystemAnyOne Internal Implant SystemBLUEDIAMOND IMPLANT SystemST Internal Implant SystemARi ExCon Implant System | XPEED AnyRidge Internal Implant SystemBLUEDIAMOND IMPLANT SystemAnyOne Internal Implant System |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the prior cleared Predicate device.
- Indications for Use, Design, Diameter, Total Length, Angulation, Connection Interface, Material, Single Use, and Sterilization
2. Difference
There are no differences with the Predicate device.
3. Discussion
The proposed EZ Post Cylinder and predicate device have common in all items in the comparison, and can be considered practically equivalent.
{16}------------------------------------------------
(5) CCM Abutment
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) No. | K242030 | K182448 |
| Device Name | CCM Abutment | CCM Abutment |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | MegaGen Dental Implant Abutment is intended to besurgically placed in the maxillary or mandibular areas for thepurpose providing prosthetic support for dental restorations(Crown, bridges, and overdentures) in partially or fullyedentulous individuals. It is used to restore a patient'schewing function.All digitally designed abutments for use with TiGEN Abutmentand ZrGEN Abutment are intended to be sent to a MegaGenvalidated milling center for manufacture | The BLUEDIAMOND IMPLANT System is intended to besurgically placed in the maxillary or mandibular molar areas forthe purpose providing prosthetic support for dentalrestorations (Crown, bridges, and overdentures) in partially orfully edentulous individuals. It is used to restore a patient'schewing function in the following situation and with the clinicalprotocols:- Immediate loading when good primary stability is achievedand with appropriate occlusal loading. |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameter ( $Ø$ ,mm) | 3.8 | 3.8 |
| Post Height(mm) | 11.0 | 11.6 |
| Total Length(mm) | 14.7 | 14.65 ~ 16.15 |
| Angulation (°) | Straight | Straight |
| ConnectionInterface | Internal Hex, Internal Non-Hex | Internal Octa, Internal Non-Octa |
| Material | Body: Co-Cr-Mo alloySleeve: POM (Delrin 100P NC010) | Body: Co-Cr-Mo alloySleeve: POM (Delrin 100P NC010) |
| SurfaceTreatment | N/A | N/A |
| Single Use | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
| CompatibleImplantSystem | XPEED 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 Reference device.
- Indication for use, Design, Diameter, Angulation, Material, Surface Treatment, Single Use and Sterilization
2. Differences
The subject device has the different characteristic for the followings compared to the Reference device.
- Post Height
The Post Height of subject device is slightly smaller than the prior cleared reference device. But, the size can be possible to operate more precise treatment's condition. Therefore, it does not cause a matter in substantial equivalence.
- Total Length
The Total Length of subject device is slightly different with the reference device, but the within range of cleared reference device. Also, it does not cause a matter in substantial equivalence since the size difference is very minor.
- Connection Interface
The connection interface depends on the compatible implant system. Both features of Octa and Hex provides anti-rotational feature.
- Discussion
The proposed CCM Abutment and Reference device have common in all items in the comparison chart except the Post Height, Total Length and Connection Interface. These differences are explained not affecting on device's functions and
{17}------------------------------------------------
safety. Also, the proposed product is straight type abutment, the fatigue test was performed as a representative of the worst-case model with angle. On the basis of the discussion above, it is concluded that the substantially equivalent to the Reference device.
{18}------------------------------------------------
(6) Gold Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K242030 | K203554 | K123988 |
| Device Name | Gold Abutment | Gold Abutment | Gold Abutment |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | MegaGen Dental Implant Abutment isintended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.All digitally designed abutments for usewith TiGEN Abutment and ZrGENAbutment are intended to be sent to aMegaGen validated milling center formanufacture | The AnyOne External Implant System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prostheticsupport for dental restorations (Crown,bridges, and overdentures) in partiallyor fully edentulous individuals. It is usedto restore a patient's chewing function.Smaller implants (less than 6.0 mm) arededicated for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading. Largerimplants are dedicated for the molarregion and are indicated for delayedloading. | The AnyOne Internal Implant System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prostheticsupport for dental restorations (Crown,bridges, and overdentures) in partiallyor fully edentulous individuals. It is usedto restore a patient's chewing function.Smaller implants (less than 6.0 mm) arededicated for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading.Larger implants are dedicated for themolar region and are indicated fordelayed loading. |
| Design | Image: Red dental abutment | Image: Red dental abutment | Image: Red dental abutment |
| Diameter (Ø,mm) | 3.8 | 4.0, 4.5, 5.5 | 4.5 |
| Post Height(mm) | 11.0 | 10.0 | 11.0 |
| Total Length(mm) | 14.7 | 11.0, 11.2 | 15.7 |
| Angulation (°) | Straight | Straight | Straight |
| ConnectionInterface | Internal Hex, Internal Non-Hex | External Hex, External Non-Hex | Internal Hex, Internal Non-Hex |
| Material | Body: Gold alloySleeve: POM (Delrin 100P NC010) | Body: Gold alloySleeve: POM (Delrin 100P NC010) | Body: Gold alloySleeve: POM (Delrin 100P NC010) |
| SurfaceTreatment | N/A | N/A | N/A |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| CompatibleImplantSystem | XPEED AnyRidge Internal ImplantSystem | AnyOne External Implant System | AnyOne Internal Implant System |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the Reference devices.
- Indication for use, Design, Post Height, Angulation Interface, Material, Surface Treatment, Single Use and Sterilization 2. Differences
The subject device has the different characteristic for the followings compared to the Reference devices.
- Diameter
The Diameter of subject device is slightly smaller than the prior cleared reference devices. But, the size can be possible to operate more precise treatment's condition. Therefore, it does not cause a matter in substantial equivalence.
- Total Length
The Total Length of subject device is slightly different with the reference device 1, but the total length lies within range of cleared reference devices. Also, it does not cause a matter in substantial equivalence since the size difference is very minor.
3. Discussion
The proposed Gold Abutment and Reference devices have common in all items in the comparison chart except the Diameter and
{19}------------------------------------------------
Total Length. These differences are explained not affecting on device's fundamental functions and safety. Also, the proposed product is straight type abutment, the fatigue test was performed as a representative of the worst-case model with angle. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the Reference devices.
{20}------------------------------------------------
(7) Octa Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K242030 | K182448 | K110955 |
| Device Name | Octa Abutment | Octa Abutment | Octa Abutment |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | MegaGen Dental Implant Abutment isintended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.All digitally designed abutments for usewith TiGEN Abutment and ZrGENAbutment are intended to be sent to aMegaGen validated milling center formanufacture | The BLUEDIAMOND IMPLANT System isintended to be surgically placed in themaxillary or mandibular molar areas forthe purpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function inthe following situation and with theclinical protocols:- Immediate loading when good primarystability is achieved and with appropriateocclusal loading. | The AnyRidge Internal Implant Systemis intended to be surgically placed inthe maxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than Ø6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriate occlusalloading. Larger implants are dedicatedfor the molar region and are indicatedfor delayed loading. |
| Design | Image: Subject Device Design | Image: Reference Device 1 Design | Image: Reference Device 2 Design |
| Diameter (Ø,mm) | 3.8, 4.8, 5.8 | 3.8, 4.8, 5.8 | 4.8 |
| Gingival Height(mm) | 0.8, 1.8, 2.8, 3.8, 4.8 | 0.8, 1.8, 2.8, 3.8, 4.8 | 2.0, 3.0, 4.0, 5.0 |
| Total Length(mm) | 8.0 ~ 12.0 | 7.85 ~ 14.85 | 9.0 ~ 12.0 |
| Angulation (°) | Straight | Straight | Straight |
| ConnectionInterface | 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) |
| SurfaceTreatment | Anodizing | Anodizing | Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| CompatibleImplantSystem | XPEED AnyRidge Internal ImplantSystem | BLUEDIAMOND IMPLANT System | AnyRidge Internal Implant System |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the Reference devices.
- Indications for Use, Design, Diameter, Gingival Height, Angulation, Connection Interface, Material, Surface Treatment, Single Use and Sterilization
2. Differences
There are no differences with the Reference devices.
3. Discussion
The proposed Octa Abutment and Reference devices have common in all the terms in the comparison, and can be considered practically equivalent.
Fatigue testing was conducted on the proposed Octa Abutment because it is the worst-case model within a compatible implant system (XPEED AnyRidge Internal Implant System). The test result supports that the substantially equivalent to the reference devices and the difference it not affecting the substantial equivalence.
*The Octa Abutment diameter for K182448, which has previously been cleared by the FDA, was not identified in the 510(k) Summary, but was included in the submitted document and has been added.
{21}------------------------------------------------
(8) ZrGEN Abutment
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) No. | K242030 | K220562 |
| Device Name | ZrGEN Abutment | ZrGEN Abutment |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | MegaGen Dental Implant Abutment is intended to besurgically placed in the maxillary or mandibular areas for thepurpose providing prosthetic support for dental restorations(Crown, bridges, and overdentures) in partially or fullyedentulous individuals. It is used to restore a patient'schewing function.All digitally designed abutments for use with TiGEN Abutmentand ZrGEN Abutment are intended to be sent to a MegaGenvalidated milling center for manufacture | The TiGEN Abutment, ZrGEN Abutment and Scan HealingAbutment are intended for use on endosseous dentalimplants in the edentulous or partially edentulous maxilla ormandible, as an aid in prosthetic rehabilitation.For TiGEN Abutment and ZrGEN Abutment, all digitallydesigned abutments for use with TiGEN Abutment and ZrGENAbutment are intended to be sent to a MegaGen-validatedmilling center for manufacture. |
| Design | Image: Zirconia top-half | Image: Zirconia top-half |
| Diameter (Ø,mm) | 4.0, 4.3, 4.4, 5.0, 5.5, 6.5 | 3.1, 3.9, 4.0, 4.3, 4.4, 4.5, 5.0, 5.5, 6.0, 6.5 |
| Total Length(mm) | 5.8 ~ 14.9 | 5.1 ~ 16.55 |
| Top-halfMaterial | Zirconia ISO13356 | Zirconia ISO13356 |
| Range of Top-half DesignParameter(mm) | Diameter: Min 8.0Gingival Collar Height: Min 2.0Post Height: 7.0 | Diameter: Min 8.0Gingival Collar Height: Min 2.0Post Height: 7.0 |
| Angulation (°) | Straight | Straight |
| ConnectionInterface | Internal Hex, Internal Non-HexInternal Octa, Internal Non-Octa | Internal, External |
| Metallic BaseMaterial | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) |
| SurfaceTreatment | Machined | Machined |
| Single Use | Yes | Yes |
| Sterilization | Non-Sterile | Non-Sterile |
| CompatibleImplant System | XPEED AnyRidge Internal Implant SystemAnyOne Internal Implant SystemST Internal Implant System | XPEED AnyRidge Internal Implant SystemAnyOne Internal Implant SystemBLUEDIAMOND IMPLANT System |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the prior cleared Reference device.
- Indications for Use, Design, Diameter, Total Length, Top-half Design Parameter, Angulation, Connection Interface, Metallic Base Material, Surface Treatment, Single Use, and Sterilization
2. Difference
There are no differences with the Reference device.
3. Discussion
The proposed ZrGEN Abutment and reference device have common in all the terms in the comparison, and can be considered practically equivalent.
The octa type of ZrGEN Abutment compatible with XPEED AnyRidge Internal Implant System is an abutment connected to the proposed Octa Abutment, the worst model in the implant system so a fatigue test was conducted the proposed Octa abutment. In addition, fatigue testing was conducted on the ZrGEN Abutment compatible with AnyOne Internal Implant System because it is
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the worst model within the compatible implant system. The test result supports that the substantially equivalent to the reference devices and the difference it not affecting the substantial equivalence.
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(9) TiGEN Abutment
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) No. | K242030 | K220562 |
| Device Name | TiGEN Abutment | TiGEN Abutment |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | MegaGen Dental Implant Abutment is intended to besurgically placed in the maxillary or mandibular areas for thepurpose providing prosthetic support for dental restorations(Crown, bridges, and overdentures) in partially or fullyedentulous individuals. It is used to restore a patient'schewing function.All digitally designed abutments for use with TiGEN Abutmentand ZrGEN Abutment are intended to be sent to a MegaGenvalidated milling center for manufacture | The TiGEN Abutment, ZrGEN Abutment and Scan HealingAbutment are intended for use on endosseous dentalimplants in the edentulous or partially edentulous maxilla ormandible, as an aid in prosthetic rehabilitation.For TIGEN Abutment and ZrGEN Abutment, all digitallydesigned abutments for use with TiGEN Abutment and ZrGENAbutment are intended to be sent to a MegaGen-validatedmilling center for manufacture. |
| Design | Image: TiGEN Abutment | Image: TiGEN Abutment |
| Diameter (Ø,mm) | 10.0, 12.0 | 10.0, 12.0 |
| Total Length(mm) | 28.70, 28.85 | 26.00 ~ 30.55 |
| Angulation (°) | Up to 30° | Up to 30° |
| ConnectionInterface | Internal Hex, Internal Non-Hex | Internal, External |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) |
| SurfaceTreatment | Anodizing | Anodizing |
| Single Use | Yes | Yes |
| Sterilization | Non-Sterile | Non-Sterile |
| CompatibleImplant System | ST Internal Implant System | XPEED AnyRidge Internal Implant SystemAnyOne Internal Implant SystemBLUEDIAMOND IMPLANT System |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the prior cleared Reference device.
- Indications for Use, Design, Diameter, Total Length, Angulation, Connection Interface, Material, Single Use, and Sterilization
2. Difference
There are no differences with the Reference device.
3. Discussion
The proposed TiGEN Abutment and reference device have common in all the terms in the comparison, and can be considered practically equivalent. Also, fatigue testing was conducted on the TiGEN Abutment compatible with System because it is the worst model within the compatible implant system. The the subject device is substantially equivalent to the reference devices and the difference it not affecting the substantial equivalence.
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(10) AXA Abutment – Straight Type
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K242030 | K233450 | K203808 |
| Device Name | AXA Abutment | AXA Abutment (Straight) | Multi-unit Abutment |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | MegaGen Dental Implant Abutment isintended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.All digitally designed abutments for usewith TIGEN Abutment and ZrGENAbutment are intended to be sent to aMegaGen validated milling center formanufacture | The MegaGen Dental Implant Abutmentis intended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic supportfor dental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.All digitally designed abutments for usewith ZrGEN Abutment are intended tobe sent to a MegaGen validated millingcenter for manufacture | The Multi-unit Abutment, Multi-unitAngled Abutment is intended to besurgically placed in the maxillary ormandibular arches for the purposeproviding prosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. |
| Design | Image: Abutment Design | Image: Abutment Design | Image: Abutment Design |
| Diameter ( $Ø$ ,mm) | 4.2 | 4.0, 5.0 | 4.8 |
| Gingival Height(mm) | 2.0, 3.0, 4.0, 5.0, 6.0 | 1.8, 2.8, 3.8, 5.8, 7.8 | 0.6, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5,5.0, 5.5 |
| Post Height(mm) | 4.0 | 4.0, 6.0 | 1.8, 2.2 |
| Total Length(mm) | 7.5 ~ 11.5 | 11.05 ~ 20.1 | 6.2 ~ 12.84 |
| Angulation (°) | Straight | Straight | Straight |
| ConnectionInterface | Internal Conical Connection | Internal Hex,Internal Non-Hex,Internal Conical Connection | Internal Hex,Internal Non-Hex,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) |
| SurfaceTreatment | Anodizing | Anodizing, Machined | Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| CompatibleImplant System | ARi ExCon Implant System | XPEED AnyRidge Internal ImplantSystemAnyOne Internal Implant SystemBLUEDIAMOND IMPLANT System | XPEED AnyRidge Internal ImplantSystemAnyOne Internal Implant SystemBLUEDIAMOND 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, Post Height, Angulation, Connection Interface, Material, Surface Treatment, Single Use and Sterilization
2. Differences
The subject device has the different characteristic for the followings compared to the Predicate device. - Diameter
The Diameter of the subject device is slightly different with the predicate device, but this diameter lies within range of the predicate device.
- Gingival Height
The Gingival Height of the subject device is slightly different with the predicate device, but all gingival heights lie within range of the predicate device.
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3. Discussion
The proposed AXA Abutment and Predicate device have common in all the terms in the comparison chart except Diameter and Gingival Height. These differences are explained not affecting on device's fundamental functions and safety. Also, the proposed product is straight type abutment, the fatigue test was performed as a representative of the worst-case model with angle. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the Reference devices.
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(11) AXA Abutment – Angled Type
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K242030 | K233450 | K203808 |
| Device Name | AXA Abutment | AXA Abutment (Angled) | Multi-unit Angled Abutment |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | MegaGen Dental Implant Abutment isintended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.All digitally designed abutments for usewith TiGEN Abutment and ZrGENAbutment are intended to be sent to aMegaGen validated milling center formanufacture | The MegaGen Dental Implant Abutmentis intended to be surgically placed in themaxillary or mandibular areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.All digitally designed abutments for usewith ZrGEN Abutment are intended to besent to a MegaGen validated millingcenter for manufacture | The Multi-unit Abutment, Multi-unitAngled Abutment is intended to besurgically placed in the maxillary ormandibular arches for the purposeproviding prosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. |
| Design | |||
| Diameter (Ø,mm) | 4.2, 4.75 | 4.0, 5.0 | 4.8, 5.0 |
| Gingival Height(mm) | 3.0, 3.1, 4.0, 4.1, 5.0, 5.1, 6.0, 6.1 | 3.8, 5.8, 7.8 | 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5 |
| Post Height(mm) | 4.0 | 2.0, 4.0, 6.0 | 2.2, 3.9 |
| Total Length(mm) | 5.865 ~ 9.65 | 6.4 ~ 10.85 | 3.4 ~ 8.85 |
| Angulation (°) | 12°, 20°, 30° | 20°, 30° | 17°, 29°, 30° |
| ConnectionInterface | External Hex | Internal Hex,Internal Non-Hex, Internal Octa,Internal Non-Octa | Internal Hex,Internal Non-Hex, Internal Octa,Internal Non-Octa |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) |
| SurfaceTreatment | Anodizing | Anodizing, Machined | Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Additional PostComponent | EZ Post Cylinder | EZ Post Cylinder | Yes |
| CompatibleImplantSystem | ARi ExCon Implant System | XPEED AnyRidge Internal ImplantSystemAnyOne Internal Implant SystemBLUDIAMOND Implant System | XPEED AnyRidge Internal ImplantSystemAnyOne Internal Implant SystemBLUDIAMOND Implant System |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the prior cleared Predicate device and/or reference device.
- Indications for Use, Design, Post Height, Material, Surface Treatment, Single Use and Sterilization
2. Differences
The subject device has the different characteristic for the followings compared to the Predicate device. - Diameter
The Diameter of the subject device is slightly different with the predicate device, but this diameter lies within range of the predicate device.
- Gingival Height
The Gingival Height of the subject device is slightly different with the predicate device, but all gingival heights lie within range of the predicate device and reference device.
- Total Length
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The Total Length of the subject device is slightly different with the predicate device. But all total lengths lie within range of the predicate device and reference device.
- Angulation
The angles of the subject device are 12°, 20° and 30° angle are same as the predicate device. 12° angle is sightly different from the predicate device, but the angle can be possible to operate more precise treatment to meet each patient's condition. Therefore, it does not cause a matter in substantial equivalence. - Connection Interface
The connection interface depends on the compatible implant system.
3. Discussion
The proposed AXA Abutment and Predicate device have common in all the terms in the comparison chart except Diameter, Gingival Height, Total length and Angulation. These differences are explained not affecting on device's functions and safety. Also, the fatigue test was performed on the subjected AXA Abutment (Angled Type) as the representative model for the worst case with an angle to confirm the substantial equivalence. The test result supports that the substantially equivalent to the reference devices and the difference it not affecting the substantial equivalence.
On the basis of the discussion above, it is concluded that the substantially equivalent to the Reference devices.
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(12) Abutment Screw
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) No. | K242030 | K233450 |
| Device Name | Abutment Screw | Abutment Screw |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUseStatement | MegaGen Dental Implant Abutment is intended to besurgically placed in the maxillary or mandibular areas for thepurpose providing prosthetic support for dental restorations(Crown, bridges, and overdentures) in partially or fullyedentulous individuals. It is used to restore a patient'schewing function.All digitally designed abutments for use with TiGEN Abutmentand ZrGEN Abutment are intended to be sent to a MegaGenvalidated milling center for manufacture | The MegaGen Dental Implant Abutment is intended to besurgically placed in the maxillary or mandibular areas for thepurpose providing prosthetic support for dental restorations(Crown, bridges, and overdentures) in partially or fullyedentulous individuals. It is used to restore a patient's chewingfunction. All digitally designed abutments for use with ZrGENAbutment are intended to be sent to a MegaGen validatedmilling center for manufacture. |
| Design | Image: Abutment Screw | Image: Abutment Screws |
| Diameter (Ø,mm) | 2.2, 2.25, 2.3, 2.6 | 2.0, 2.1, 2.2 |
| Total Length(mm) | 4.7 ~ 9.9 | 7.9 ~ 12.7 |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) |
| SurfaceTreatment | Machined, Anodizing | Machined, Anodizing |
| Single Use | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
| CompatibleImplantSystem | ARI ExCon Implant System | XPEED AnyRidge Internal Implant SystemAnyOne Internal Implant SystemBLUDIAMOND Implant System |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the Predicate device.
- Indication for use, Design, Material, Surface Treatment, Single Use and Sterilization
2. Differences
The subject device has the different characteristic for the followings compared to the Predicate device.
- Diameter
The Diameter (2.2 mm) of the subject device is same as the predicate device. Other diameters (2.25, 2.3 and 2.6 mm) are sightly longer than the predicate device, but the variety of 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.
- Total Length
The Total Length of the subject device is slightly different with the predicate device, but it does not cause a matter in substantial equivalence since the size differences are very minor.
3. Discussion
The proposed Abutment Screw and Predicate device have common in all the terms in the comparison chart except Diameter and Total length. These differences are explained not affecting on device's fundamental functions and safety. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the Predicate device.
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8. Summary of Non-Clinical Testing
The non-clinical testing data which are submitted, referenced, or relied on in this submission support demonstrating substantial equivalence.
Biocompatibility
The biocompatibility evaluation has been performed in accordance with International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The biocompatibility of the subject device was performed through cleared K110955, K123988 and K210161, which has same materials and manufacturing process.
Sterilization validation
The Healing Abutment is provided as sterile devices. The Sterilization validating testing has been performed in accordance with ISO 11137 to verify the sterility assurance level (10°) under the previous 510(k) submission, K220562. The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 years shelf life. The sterilization validation of the supplied sterile subject device can be leveraged with prior cleared reference device, K220562.
The subject devices excluding the sterile device are supplied in non-sterilization validating testing for steam sterilization by the user has been performed in accordance with ISO 17665-1, 2 to verify the sterility assurance level (10°). Validation Testing was conducted on a worst-case test article from our previously cleared reference device, K220562, E220672, K210161, K123988.
Accelerated shelf life Test
The accelerated shelf life study was performed in accordance with ASTM F1980 and it was leveraged from the prior cleared Healing Abutment of K110955.
Pyrogen and Endotoxin Test
The subject device will not be labeled as "non-pyrogenic", and the endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL in accordance with the USP 39 <85>.
Performance Testing
The bench tests have been performed in accordance with 'ISO 14801' and the recommendations of 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to evaluate the performance of the subject devices and the test results met the pre-set criteria.
MR Compatibility
The MR compatibility was performed to access the risk of exposing patients who have implantable medical devices according to FDA's guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".
An assessment was made to demonstrate that the subject devices do not configure a new worst case and can be represented by the previously conducted studies reviewed for reference devices obtained the status of MR Conditional per K230618. Therefore, the subject devices are MR conditional devices and a patient the subject devices can be safely scanned observing the parameters previously established per reference devices.
9. Conclusion
Based on the information provided in this premarket notification, We, MegaGen Implant Co., Ltd. conclude that the MegaGen Dental Implant Abutment is substantially equivalent to the predicate device as here.
§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)