← Product Code [NHA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA) · K192614 # Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (K192614) _Megagen Implant Co., Ltd. · NHA · Feb 13, 2020 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K192614 ## Device Facts - **Applicant:** Megagen Implant Co., Ltd. - **Product Code:** [NHA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA.md) - **Decision Date:** Feb 13, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3630 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use The Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. Intended for fully edentulous jaw retaining a tissue supported overdenture. The abutments in combination with endosseous implants are used as the foundation for anchoring tooth replacements in either jaw. The attachments are used in fixed overdenture restorations that can be attached with a snap-in system. ## Device Story Device consists of dental implant abutments (Meg-Ball, Meg-Loc, Meg-Magnet) and associated components (metal caps, retentive rings) used as a superstructure for endosseous dental implants. Abutments connect to implants via threaded internal hex or octa connections; they provide a foundation for removable or fixed overdentures. Meg-Ball and Meg-Loc abutments use mechanical snap-in attachments; Meg-Magnet uses magnetic force. Used in dental clinics by dentists/prosthodontists. Output is a stable prosthetic foundation for overdentures, allowing insertion/removal by the patient. Benefits include restored chewing function and denture stabilization. Device is supplied non-sterile for user-performed steam sterilization. ## Clinical Evidence No clinical data. Bench testing only. Performance testing included retentive force measurements per FDA guidance for endosseous dental implant abutments. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, irritation, sensitization, acute systemic toxicity). Surface treatment (TiN coating) evaluated for thickness, composition, and adhesion. ## Technological Characteristics Materials: Ti-6Al-4V ELI (abutments/caps), Fluorinated Rubber (rings), Stainless Steel (Meg-Magnet). Surface: Machined or TiN coated. Connection: Internal Hex/Octa. Sterilization: Non-sterile (validated for user steam sterilization). Form factor: Straight abutments for overdenture support. ## Regulatory 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 - Osstem Abutment System ([K182091](/device/K182091.md)) ## Reference Devices - Osstem Implant System Abutment ([K161689](/device/K161689.md)) - MagDen Dental Implant System ([K162867](/device/K162867.md)) - AnyOne Internal Implant System ([K123988](/device/K123988.md)) - LOCATOR F-Tx Implant Attachment System ([K151789](/device/K151789.md)) - Ball Abutment System ([K101890](/device/K101890.md)) ## Related Devices - [K984297](/device/K984297.md) — MAGNA ABUTMENT · Factor, Ii, Inc. · Jan 28, 2000 - [K131526](/device/K131526.md) — SFI-BAR · Cendres & Metaux SA · Sep 23, 2013 - [K080598](/device/K080598.md) — MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS · Intra-Lock International · May 21, 2008 - [K231753](/device/K231753.md) — Oneday Implant Abutment · Oneday Biotech Co., Ltd. · Feb 21, 2024 - [K251547](/device/K251547.md) — DESS Dental Smart Solutions · Terrats Medical SL · Oct 31, 2025 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. February 13, 2020 MegaGen Implant CO., Ltd. You Jung Kim Chief Researcher 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun Daegu. 42921 REPUBLIC OF KOREA Re: K192614 Trade/Device Name: Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 14, 2019 Received: November 18, 2019 Dear You Jung Kim: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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. Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K192614 # Device Name Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment Indications for Use (Describe) The Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet is intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. Intended for fully edentulous jaw retaining a tissue supported overdenture. The abutments in combination with endosseous implants are used as the foundation for anchoring tooth replacements in either jaw. The attachments are used in fixed overdenture restorations that can be attached with a snap-in system. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <span> <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | 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 and review the collection of information. Send comments regarding this burden estimate or any other aspec 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." {3}------------------------------------------------ # 510(k) Summary # Date: Feb 13, 2020 ## 1. MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828 # 2. Submission Correspondent You Jung Kim MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Fax: +82-53-289-3420 Tel: +82-53-222-2985 Email:rmd_ra4@imegagen.com # 3. Device | ▪ Trade Name: | Meg-Ball Attachment System, Meg-Loc Abutment,<br>Meg-Magnet Abutment | |--------------------------------|----------------------------------------------------------------------| | ▪ Common Name: | Endosseous Dental Implant Abutment | | ▪ Classification Name: | Abutment, Implant, Dental, Endosseous | | ▪ Classification Product Code: | NHA | | ▪ Classification regulation: | Class II, 21 CFR 872.3630 | #### 4. Predicate Device - י Primary Predicate Device: K182091 – Osstem Abutment System - . Reference Devices: - K161689– Osstem Implant System Abutment K162867 - MagDen Dental Implant System K123988 – AnyOne Internal Implant System K151789 - LOCATOR F-Tx Implant Attachment System K101890 – Ball Abutment System {4}------------------------------------------------ # 5. Description Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is a superstructure of a dental implant system to provide support for prosthetic restorations. It is intended to be used in implant-retained and removable overdenture restorations where the patient is fully edentulous. Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is compatible with the following FDA cleared MegaGen Implant system. | Manufacturer | Device Name | 510(k) Number | Connection | Diameter (mm) | |------------------------------|------------------------------|---------------------|---------------|-----------------------------------------------------| | MegaGen Implant<br>Co., Ltd. | AnyRidge<br>Internal Fixture | K110955,<br>K122231 | Internal Hex | 4.0, 4.4, 4.9, 5.4, 5.9,<br>6.4, 6.9, 7.4, 7.9, 8.4 | | | AnyOne<br>Internal Fixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8,<br>6.3, 6.8, 7.3, 7.8, 8.3 | | | AnyRidge Octa 1<br>Fixture | K182448 | Internal Octa | 3.3, 3.7, 4.1, 4.4, 4.8 | | | ExFeel<br>Internal Fixture | K052369 | Internal Hex | 4.8 | The subject device is consisted of the following devices. | Component | Content | | | |----------------------------------|----------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Meg-Ball<br>Attachment<br>System | Meg-Ball<br>Abutment | Description | Meg-ball Abutment is intended to be used in<br>completely edentulous jaws and connects to an<br>overdenture to allow its insertion and removal. Meg-<br>ball abutment has a ball shaped. | | | | Material Composition | Ti-6A1-4V ELI | | | | Diameter | 2.91, 3.13, 3.40, 3.50 mm | | | | Head Diameter | 2.25 mm | | | | Head Length | 4.15 mm | | | | Gingival Heights | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8 mm | | | | Total Length | 9.5, 10, 10.1, 10.6, 10.65, 10.75, 11, 11.15, 11.25,<br>11.6, 12, 12.15, 12.25, 12.6, 13, 13.15, 13.25, 13.6,<br>14, 14.15, 14.25, 14.6, 15, 15.15, 15.25, 15.6, 16.15,<br>16.25 mm | | | | Angulation | Straight | | | | Compatible Implant System | AnyRidge Internal Implant System<br>AnyOne Internal Implant System<br>AnyRidge Octa 1 Implant System<br>ExFeel Internal Implant System | | Metal<br>Housing | Metal<br>Cap | Description | Metal cap has shape of cap to protect and hold the<br>retentive ring. It is fixed into the denture and is applied<br>to Meg-ball abutment to stabilize the denture. | | | | Material<br>Composition | Ti-6A1-4V ELI | | | | Diameter | 5.0 mm | | | | Height | 4.0 mm | | | Retentive<br>Ring | Description | Retentive ring has shape of ring to connect to Meg-<br>ball abutment. It is inserted into the metal cap and<br>serves as a buffer for the abutment and denture<br>stabilizing, and can be replaced. | | | | Material | Fluorinated Rubber | {5}------------------------------------------------ | | | | Composition | | |----------------------------|---------------------------|--|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | Diameter | 4.5 mm | | | | | Height | 1.5 mm | | | Description | | | Meg-Loc Abutment is intended to be used in<br>completely edentulous jaws and connects to an<br>overdenture to allow its insertion and removal. Meg-<br>Loc abutment has a truncated head. | | | Material Composition | | | Ti-6A1-4V ELI | | | Diameter (Head) | | | 3.89 mm | | | Diameter (Body) | | | 2, 2.45, 3.14, 3.4, 3.5 mm | | Meg-Loc<br>Abutment | Gingival Height | | | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8 mm | | | Total Length | | | 6.85, 7.35, 7.45, 7.95, 8, 8.1, 8.35, 8.5, 8.6, 8.95, 9.35,<br>9.5, 9.6, 9.95, 10.35, 10.5, 10.6, 10.95, 11.35, 11.5,<br>11.6, 11.95, 12.35, 12.5, 12.6, 12.95, 13.5, 13.6 mm | | | Angulation | | | Straight | | | Compatible Implant System | | | AnyRidge Internal Implant System<br>AnyOne Internal Implant System<br>AnyRidge Octa 1 Implant System<br>ExFeel Internal Implant System | | | Description | | | Meg-Magnet Abutment is intended to be used in<br>completely edentulous jaws and connects to an<br>overdenture to allow its insertion and removal using<br>the magnetic force of the magnet attachment<br>(D356767). Meg-Magnet abutment has a flat head. | | | Material Composition | | | Stainless Steel | | | Surface Treatment | | | TiN coating | | | Diameter (Head) | | | 4.5, 5.0 mm | | Meg-<br>Magnet<br>Abutment | Diameter (Body) | | | 2, 2.45, 3.56, 4.86 mm | | | Gingival Height | | | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8 mm | | | Total Length | | | 5.65, 5.85, 6.15, 6.75, 6.8, 6.9, 7.15, 7.3, 7.4, 7.75,<br>8.15, 8.3, 8.4, 8.75, 9.15, 9.3, 9.4, 9.75, 10.15, 10.3,<br>10.4, 10.75, 11.3, 11.4 mm | | | Angulation | | | Straight | | | Compatible Implant System | | | AnyRidge Internal Implant System<br>AnyOne Internal Implant System<br>AnyRidge Octa 1 Implant System<br>ExFeel Internal Implant System | #### 6. Indication for use Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. Intended for fully edentulous jaw retaining a tissue supported overdenture. The abutments in combination with endosseous implants are used as the foundation for anchoring tooth replacements in either jaw. The attachments are used in fixed overdenture restorations that can be attached with a snap-in system. {6}------------------------------------------------ #### 7. Basis for Substantial Equivalence Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is substantially equivalent to the predicate devices in terms of intended use, technical characteristics, function, and performance. They are made of the same material (except for the retentive ring) and have a similar design. The size range of subject device slightly differ from the predicate devices however it is very minor not affecting substantial equivalence. The subject device is composed of the straight type abutments that are used for supporting the overdenture, while the predicate & reference devices address complete dental implant system including various fixtures and abutments. For this reason, the indication for use statements between subject and predicate devices are different but, the proposed indication is available to apply to predicate/reference devices as well, since the submission device is a sub-set of devices included in the predicate & reference device. Also, the indications for use statements of the subject device and the predicate and reference devices have the same intended to provide the provide the prosthetic support for dental restorations such as crown, bridges, and overdenture to restore patient's chewing function. This minor difference in wording does not affect the substantial equivalence of the subject device. The indication for use statement of subject device is substantially equivalent to the predicate device. In order to demonstrate the difference does not raise any new issues, each performance test on the subject and predicate device have been performed in consideration of the worst case according to 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to figure out physical property (e.g. retentive force). Fatigue testing was not conducted based on above FDA Guidance Document because the proposed abutments is straight type. The subject abutment is intended for straight implantation, and does not receive single load, because it used for supporting the overdenture for which the load is dispersed to the full denture. The st result shows that the performance of subject device supports the substantial equivalence to the predicate device. Based on the detailed comparison charts below and test results provided in this submission, we conclude that the subject device is substantially equivalent to the predicate devices. {7}------------------------------------------------ #### • Meg-Ball Abutment | | Subject Device | Predicate Device | Reference Device<br>1 | Reference Device<br>2 | Reference Device<br>3 | | ExFeel Internal<br>Implant System | MS SA Implant<br>System | | | | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | K192614 | K182091 | K161689 | K123988 | K101890 | Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | Ti-6A1-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | | Device Name | Meg-Ball<br>Abutment<br>For Meg-Ball Attachment<br>System,<br>Meg-Loc Abutment,<br>Meg-Magnet Abutment | Stud Abutment<br>For Osstem Abutment<br>System | Stud Abutment<br>For OSSTEM Implant System-<br>Abutment | Ball Abutment<br>For<br>AnyOne™ Internal Implant<br>System | Ball Abutment<br>For Ball Abutment<br>System | Surface<br>Treatment | Machined surface | Partial TiN coating | Partial TiN coating | Machined surface | Machined surface | | Manufacturer | MegaGen Implant Co.,<br>Ltd. | Osstem Implant Co.,<br>Ltd. | Osstem Implant Co.,<br>Ltd. | MegaGen Implant Co.,<br>Ltd. | MegaGen Implant Co.,<br>Ltd. | Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | | Indications for<br>Use Statement | Meg-Ball<br>Attachment System,<br>Meg-Loc Abutment,<br>Meg-Magnet<br>Abutment is<br>intended to be used<br>in the upper or lower<br>jaw and used for<br>supporting tooth<br>replacements to<br>restore chewing<br>function. Intended<br>for fully edentulous<br>jaw retaining a<br>tissue supported<br>overdenture.<br>The abutments in<br>combination with<br>endosseous implants<br>are used as the<br>foundation for<br>anchoring tooth<br>replacements in<br>either jaw. The<br>attachments are used<br>in fixed overdenture<br>restorations that can<br>be attached with a<br>snap-in system. | Osstem Abutment<br>System is intended<br>for use with a dental<br>implant to provide<br>support for<br>Prosthetic<br>restorations such as<br>crowns, bridges, or<br>overdentures. | The OSSTEM<br>Implant System -<br>Abutment is<br>intended for use<br>with a dental<br>implant to<br>provide support for<br>prosthetic<br>restorations such as<br>crowns, bridges, or<br>overdentures. | The AnyOne<br>Internal Implant<br>System is intended<br>to be surgically<br>placed in the<br>maxillary or<br>mandibular molar<br>areas for the purpose<br>providing prosthetic<br>support for dental<br>restorations (Crown,<br>bridges, and<br>overdentures) in<br>partially or fully<br>edentulous<br>individuals. It is<br>used to restore a<br>patient's chewing<br>function. Smaller<br>implants (less than<br>6.0 mm) are<br>dedicated for<br>immediate loading<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading.<br>Larger implants are<br>dedicated for the<br>molar region and are<br>indicated for<br>delayed loading. | The Ball Abutment<br>Systems are used for<br>implant retained<br>mucosa-supported<br>restorations, such as<br>overdentures where<br>the patient is fully<br>edentulous in the<br>arch to be restored.<br>There are two types<br>of Ball Abutment<br>system, internal and<br>external type, and<br>the ball abutment<br>technique is used on<br>Ball Abutment<br>System implants in<br>the maxilla or<br>mandible. | Abutment<br>Angle | Straight | Straight | Straight | Straight | Straight<br>(External Type) | | Design | Image: Meg-Ball Abutment Design | Image: Stud Abutment Design | Image: Stud Abutment Design | Image: Ball Abutment Design | Image: Ball Abutment Design | Principle of<br>Operation | This product is<br>generally applied to<br>prosthetic procedure<br>for overdentures.<br>The head part is<br>where connected to<br>overdenture with<br>attachment and the<br>screw part is<br>connected directly to<br>the endosseous<br>dental implant by<br>their threaded part. | This product is<br>generally applied to<br>prosthetic procedure<br>for overdentures.<br>The head part is<br>where connected to<br>overdenture with<br>attachment and the<br>screw part is<br>connected directly to<br>the endosseous<br>dental implant by<br>their threaded part. | This product is<br>generally applied to<br>prosthetic procedure<br>for overdentures.<br>The head part is<br>where connected to<br>overdenture with<br>attachment and the<br>screw part is<br>connected directly to<br>the endosseous<br>dental implant by<br>their threaded part. | This product is<br>generally applied to<br>prosthetic procedure<br>for overdentures.<br>The head part is<br>where connected to<br>overdenture with<br>attachment and the<br>screw part is<br>connected directly to<br>the endosseous<br>dental implant by<br>their threaded part. | This product is<br>generally applied to<br>prosthetic procedure<br>for overdentures.<br>The head part is<br>where connected to<br>overdenture with<br>attachment and the<br>screw part is<br>connected directly to<br>the endosseous<br>dental implant by<br>their threaded part. | | Diameter | 2.91, 3.13, 3.4, 3.5<br>mm | 3.5 mm | 3.5 mm | 3.4 mm | 2.85, 3.5, 4. 1, 5.0,<br>6.0mm | Substantial Equivalence Discussion | | | | | | | Head<br>Diameter | 2.25 mm | 1.7 mm | 2.25mm | 2.25 mm | 2.25mm | | | | | | | | Head Length | 4.15 mm | 2.5 mm | 3.35mm | 3.8mm | 4.0 mm | | | | | | | | Total Length | 9.5, 10, 10.1, 10.6,<br>10.65, 10.75, 11,<br>11.15, 11.25, 11.6,<br>12, 12.15, 12.25,<br>12.6, 13, 13.15,<br>13.25, 13.6, 14,<br>14.15, 14.25, 14.6,<br>15, 15.15, 15.25,<br>15.6, 16.15, 16.25 | 8.5, 8.9, 9.5, 9.9,<br>10.5, 10.9, 11.5,<br>11.9, 12.5, 12.9,<br>13.5, 13.9 | 9.35, 9.75, 10.35,<br>10.75, 11.35, 11.75,<br>12.35, 12.75, 13.35,<br>13.75, 14.35, 14.75 | 10.25, 11.5, 13.5,<br>15.5 | 9.15, 9.65, 9.85,<br>11.1, 11.65, 11.85,<br>13.1, 13.65, 13.85,<br>15.1 | | | | | | | | Compatible<br>Implant<br>System | AnyRidge Internal<br>Implant System<br>AnyOne Internal<br>Implant System<br>AnyRidge Octa 1<br>Implant System | TS SA Fixture<br>System<br>SS SA Fixture<br>System<br>US SA Fixture<br>System | TS Fixture System | AnyOne Internal<br>Implant System | ExFeel Implant<br>System<br>EZ Plus Implant<br>System<br>Rescue External<br>Implant System | | | | | | | {8}------------------------------------------------ #### Similarities 1. The subject device has similar characteristic for the following compared to the predicate/reference devices. Design, Head Diameter, Material, Surface Treatment, Sterilization, Angle and Principle of Operation #### 2. Differences The subject device has the different characteristic for the following compared to the predicate devices. - Indications for Use See Section 7 (page 4/13) . Diameter, Head Diameter and Head Length The diameter of 3.4, 3.5mm in subject device is same size as predicate/reference devices. The diameter range of the subject device is slightly different with predicate/reference devices by addition of diameter 2.91mm in subject device but it can be covered by reference device 3 and the variety of the size can be possible to operate more precise treatment to meet each patient's condition. The head length of subject device is slightly longer than predicate/reference devices. However, all of these size differences do not cause a change in the intended use of the size difference is very minor. #### 3. Discussion In order to demonstrate the differences do not raise in substantial equivalence, each performance test on the subject and predicate device have been performed to figure out physical property (e.g. retentive force) with appropriate attachment as intended. Fatigue testing is not considered based on FDA Guidance Document being as proposed abutments is straight type. The subject abutment is intended for straight implantation, and is not received single load, because it used for supporting the overdenture that means load is dispersed to the full denture. The test result shows that the performance of subject device supports the substantial equivalence to the predicate device. In conclusion, the subject device is substantially equivalent to the predicate device since the subject and predicate device have in common in indication for use, design, material, function; and the differences are minor and theses have been identified via the performance test the differences do not impact substantial equivalence. {9}------------------------------------------------ #### Metal Cap • | | Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K192614 | K182091 | K161689 | K182091 | | Device Name | Metal Cap<br>For Meg-Ball Attachment System,<br>Meg-Loc Abutment,<br>Meg-Magnet Abutment | O-ring Retainer Cap<br>For Osstem Abutment System | O-ring Retainer Cap<br>For OSSTEM Implant System-Abutment | Port Male Cap<br>For Osstem Abutment System | | Manufacturer | MegaGen Implant Co., Ltd.… --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K192614](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K192614) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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