(143 days)
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.
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. The subject device is consisted of the following devices: Meg-Ball Abutment, Metal Housing (Metal Cap, Retentive Ring), Meg-Loc Abutment, and Meg-Magnet Abutment.
This document is a 510(k) Premarket Notification for a dental device, which aims to demonstrate that a new device is substantially equivalent to existing legally marketed devices. It is not a clinical study report for an AI/ML-driven medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for AI performance and study details as it pertains to AI/ML development and validation.
The document primarily focuses on demonstrating substantial equivalence through:
- Comparison of Device Characteristics: Tables comparing the new device's components (Meg-Ball Abutment, Metal Cap, Retentive Ring, Meg-Loc Abutment, Meg-Magnet Abutment) against predicate and reference devices in terms of material, design, dimensions, and intended use.
- Non-Clinical Testing: A summary of physical property tests (e.g., retentive force), biocompatibility tests (ISO 10993 standards), and surface treatment analysis, which are standard for demonstrating the safety and performance of physical medical devices.
- No Clinical Testing: Explicitly states "No clinical studies are submitted."
Thus, there is no AI acceptance criteria or study proving AI performance to report based on the provided text.
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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.
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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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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,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:
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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 ImplantCo., Ltd. | AnyRidgeInternal Fixture | K110955,K122231 | Internal Hex | 4.0, 4.4, 4.9, 5.4, 5.9,6.4, 6.9, 7.4, 7.9, 8.4 |
| AnyOneInternal Fixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8,6.3, 6.8, 7.3, 7.8, 8.3 | |
| AnyRidge Octa 1Fixture | K182448 | Internal Octa | 3.3, 3.7, 4.1, 4.4, 4.8 | |
| ExFeelInternal Fixture | K052369 | Internal Hex | 4.8 |
The subject device is consisted of the following devices.
| Component | Content | ||
|---|---|---|---|
| Meg-BallAttachmentSystem | Meg-BallAbutment | Description | Meg-ball Abutment is intended to be used incompletely edentulous jaws and connects to anoverdenture to allow its insertion and removal. Meg-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, 11.25,11.6, 12, 12.15, 12.25, 12.6, 13, 13.15, 13.25, 13.6,14, 14.15, 14.25, 14.6, 15, 15.15, 15.25, 15.6, 16.15,16.25 mm | ||
| Angulation | Straight | ||
| Compatible Implant System | AnyRidge Internal Implant SystemAnyOne Internal Implant SystemAnyRidge Octa 1 Implant SystemExFeel Internal Implant System | ||
| MetalHousing | MetalCap | Description | Metal cap has shape of cap to protect and hold theretentive ring. It is fixed into the denture and is appliedto Meg-ball abutment to stabilize the denture. |
| MaterialComposition | Ti-6A1-4V ELI | ||
| Diameter | 5.0 mm | ||
| Height | 4.0 mm | ||
| RetentiveRing | Description | Retentive ring has shape of ring to connect to Meg-ball abutment. It is inserted into the metal cap andserves as a buffer for the abutment and denturestabilizing, and can be replaced. | |
| Material | Fluorinated Rubber |
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| Composition | ||||
|---|---|---|---|---|
| Diameter | 4.5 mm | |||
| Height | 1.5 mm | |||
| Description | Meg-Loc Abutment is intended to be used incompletely edentulous jaws and connects to anoverdenture to allow its insertion and removal. Meg-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-LocAbutment | 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, 9.35,9.5, 9.6, 9.95, 10.35, 10.5, 10.6, 10.95, 11.35, 11.5,11.6, 11.95, 12.35, 12.5, 12.6, 12.95, 13.5, 13.6 mm | |||
| Angulation | Straight | |||
| Compatible Implant System | AnyRidge Internal Implant SystemAnyOne Internal Implant SystemAnyRidge Octa 1 Implant SystemExFeel Internal Implant System | |||
| Description | Meg-Magnet Abutment is intended to be used incompletely edentulous jaws and connects to anoverdenture to allow its insertion and removal usingthe magnetic force of the magnet attachment(D356767). Meg-Magnet abutment has a flat head. | |||
| Material Composition | Stainless Steel | |||
| Surface Treatment | TiN coating | |||
| Diameter (Head) | 4.5, 5.0 mm | |||
| Meg-MagnetAbutment | 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, 7.75,8.15, 8.3, 8.4, 8.75, 9.15, 9.3, 9.4, 9.75, 10.15, 10.3,10.4, 10.75, 11.3, 11.4 mm | |||
| Angulation | Straight | |||
| Compatible Implant System | AnyRidge Internal Implant SystemAnyOne Internal Implant SystemAnyRidge Octa 1 Implant SystemExFeel 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.
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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.
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• Meg-Ball Abutment
| Subject Device | Predicate Device | Reference Device1 | Reference Device2 | Reference Device3 | ExFeel InternalImplant System | MS SA ImplantSystem | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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-BallAbutmentFor Meg-Ball AttachmentSystem,Meg-Loc Abutment,Meg-Magnet Abutment | Stud AbutmentFor Osstem AbutmentSystem | Stud AbutmentFor OSSTEM Implant System-Abutment | Ball AbutmentForAnyOne™ Internal ImplantSystem | Ball AbutmentFor Ball AbutmentSystem | SurfaceTreatment | Machined surface | Partial TiN coating | Partial TiN coating | Machined surface | Machined surface |
| Manufacturer | MegaGen Implant Co.,Ltd. | Osstem Implant Co.,Ltd. | Osstem Implant Co.,Ltd. | MegaGen Implant Co.,Ltd. | MegaGen Implant Co.,Ltd. | Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Indications forUse Statement | Meg-BallAttachment System,Meg-Loc Abutment,Meg-MagnetAbutment isintended to be usedin the upper or lowerjaw and used forsupporting toothreplacements torestore chewingfunction. Intendedfor fully edentulousjaw retaining atissue supportedoverdenture.The abutments incombination withendosseous implantsare used as thefoundation foranchoring toothreplacements ineither jaw. Theattachments are usedin fixed overdenturerestorations that canbe attached with asnap-in system. | Osstem AbutmentSystem is intendedfor use with a dentalimplant to providesupport forProstheticrestorations such ascrowns, bridges, oroverdentures. | The OSSTEMImplant System -Abutment isintended for usewith a dentalimplant toprovide support forprostheticrestorations such ascrowns, bridges, oroverdentures. | The AnyOneInternal ImplantSystem is intendedto be surgicallyplaced in themaxillary ormandibular molarareas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulousindividuals. It isused to restore apatient's chewingfunction. Smallerimplants (less than6.0 mm) arededicated forimmediate loadingwhen good primarystability is achievedand with appropriateocclusal loading.Larger implants arededicated for themolar region and areindicated fordelayed loading. | The Ball AbutmentSystems are used forimplant retainedmucosa-supportedrestorations, such asoverdentures wherethe patient is fullyedentulous in thearch to be restored.There are two typesof Ball Abutmentsystem, internal andexternal type, andthe ball abutmenttechnique is used onBall AbutmentSystem implants inthe maxilla ormandible. | AbutmentAngle | Straight | Straight | Straight | Straight | Straight(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 ofOperation | This product isgenerally applied toprosthetic procedurefor overdentures.The head part iswhere connected tooverdenture withattachment and thescrew part isconnected directly tothe endosseousdental implant bytheir threaded part. | This product isgenerally applied toprosthetic procedurefor overdentures.The head part iswhere connected tooverdenture withattachment and thescrew part isconnected directly tothe endosseousdental implant bytheir threaded part. | This product isgenerally applied toprosthetic procedurefor overdentures.The head part iswhere connected tooverdenture withattachment and thescrew part isconnected directly tothe endosseousdental implant bytheir threaded part. | This product isgenerally applied toprosthetic procedurefor overdentures.The head part iswhere connected tooverdenture withattachment and thescrew part isconnected directly tothe endosseousdental implant bytheir threaded part. | This product isgenerally applied toprosthetic procedurefor overdentures.The head part iswhere connected tooverdenture withattachment and thescrew part isconnected directly tothe endosseousdental implant bytheir threaded part. |
| Diameter | 2.91, 3.13, 3.4, 3.5mm | 3.5 mm | 3.5 mm | 3.4 mm | 2.85, 3.5, 4. 1, 5.0,6.0mm | Substantial Equivalence Discussion | |||||
| HeadDiameter | 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, 10.6,10.65, 10.75, 11,11.15, 11.25, 11.6,12, 12.15, 12.25,12.6, 13, 13.15,13.25, 13.6, 14,14.15, 14.25, 14.6,15, 15.15, 15.25,15.6, 16.15, 16.25 | 8.5, 8.9, 9.5, 9.9,10.5, 10.9, 11.5,11.9, 12.5, 12.9,13.5, 13.9 | 9.35, 9.75, 10.35,10.75, 11.35, 11.75,12.35, 12.75, 13.35,13.75, 14.35, 14.75 | 10.25, 11.5, 13.5,15.5 | 9.15, 9.65, 9.85,11.1, 11.65, 11.85,13.1, 13.65, 13.85,15.1 | ||||||
| CompatibleImplantSystem | AnyRidge InternalImplant SystemAnyOne InternalImplant SystemAnyRidge Octa 1Implant System | TS SA FixtureSystemSS SA FixtureSystemUS SA FixtureSystem | TS Fixture System | AnyOne InternalImplant System | ExFeel ImplantSystemEZ Plus ImplantSystemRescue ExternalImplant System |
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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.
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Metal Cap •
| Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|---|
| 510(k) Number | K192614 | K182091 | K161689 | K182091 |
| Device Name | Metal CapFor Meg-Ball Attachment System,Meg-Loc Abutment,Meg-Magnet Abutment | O-ring Retainer CapFor Osstem Abutment System | O-ring Retainer CapFor OSSTEM Implant System-Abutment | Port Male CapFor Osstem Abutment System |
| Manufacturer | MegaGen Implant Co., Ltd. | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. |
| Indications forUse Statement | The Meg-Ball AttachmentSystem, Meg-LocAbutment, Meg-MagnetAbutment is intended to beused in the upper or lowerjaw and used forsupporting toothreplacements to restorechewing function.Intended for fullyedentulous jaw retaining atissue supportedoverdenture. Theabutments in combinationwith endosseous implantsare used as the foundationfor anchoring toothreplacements in either jaw.The attachments are usedin fixed overdenturerestorations that can beattached with a snap-insystem. | Osstem Abutment Systemis intended for use with adental implant to providesupport for Prostheticrestorations such ascrowns, bridges, oroverdentures. | The OSSTEM ImplantSystem - Abutment isintended for use with adental implant toprovide support forprosthetic restorationssuch as crowns, bridges, oroverdentures. | Osstem Abutment Systemis intended for use with adental implant to providesupport for Prostheticrestorations such ascrowns, bridges, oroverdentures. |
| Design | Image: Metal Cap | Image: O-ring Retainer Cap | Image: O-ring Retainer Cap | Image: Port Male Cap |
| Diameter | 5 mm | 3.95mm | 5 mm | 5.5 mm |
| Height | 4 mm | 2.9 mm | 3.9mm | 2.25 mm |
| Material | Ti-6A1-4V ELI | Titanium Gr. 3 | Titanium Gr. 3 | Ti-6A1-4V ELI |
| Surfacetreatment | Machined surface | Machined surface | Machined surface | Machined surface |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Principle ofoperation | This product is generallyapplied to prostheticprocedure foroverdentures.It is inserted and fixed intodenture; and applied to balltype abutment to stabilizethe overdenture. | This product is generallyapplied to prostheticprocedure foroverdentures.It is inserted and fixed intodenture; and applied tostud type abutment tostabilize the overdenture. | This product is generallyapplied to prostheticprocedure foroverdentures.It is inserted and fixed intodenture; and applied tostud type abutment tostabilize the overdenture. | This product is generallyapplied to prostheticprocedure foroverdentures.It is inserted and fixed intodenture; and applied to porttype abutment to stabilizethe overdenture. |
| Substantial Equivalence Discussion | ||||
| 1. SimilaritiesThe subject device has similar characteristic for the following compared to the predicate/reference devices.Design, Diameter, Material, Surface Treatment, Sterilization and Principle of Operation | ||||
| 2. DifferencesThe subject device has the different characteristic for the following compared to the predicate/reference devices.Indications for Use - See Section 7 (page 4/13)- HeightThe height of subject device is slightly longer than predicate devices; there is a 0.1mm difference between reference device | ||||
| Subject Device | Predicate Device | Reference Device | ||
| 510(k) Number | K192614 | K182091 | K161689 | |
| Device Name | Retentive RingFor Meg-Ball Attachment System,Meg-Loc Abutment,Meg-Magnet Abutment | O-ringFor Osstem Abutment System | O-ringFor OSSTEM Implant System-Abutment | |
| Manufacturer | MegaGen Implant Co., Ltd. | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | |
| Indications for UseStatement | The Meg-Ball Attachment System,Meg-Loc Abutment, Meg-MagnetAbutment is intended to be used inthe upper or lower jaw and used forsupporting tooth replacements torestore chewing function. Intendedfor fully edentulous jaw retaining atissue supported overdenture.The abutments in combination withendosseous implants are used as thefoundation for anchoring toothreplacements in either jaw. Theattachments are used in fixedoverdenture restorations that can beattached with a snap-in system. | Osstem Abutment System isintended for use with a dentalimplant to provide support forProsthetic restorations such ascrowns, bridges, or overdentures. | The OSSTEM Implant System -Abutment is intended for use with adental implant toprovide support for prostheticrestorations such as crowns,bridges, or overdentures. | |
| Design | Image: Retentive Ring | Image: O-ring | Image: O-ring | |
| Diameter | 4.5mm | 3.5 mm | 4.6mm | |
| Height | 1.5 mm | Not known | 1.5 mm | |
| Material | Fluorinated Rubber | NBR (Acrylonitrile & ButadienePolymer) | NBR (Acrylonitrile & ButadienePolymer) | |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | |
| Principle ofoperation | This product is generally applied toprosthetic procedure foroverdentures.It is inserted into the Metal Cap andserves as a buffer for ball typeabutment and denture stabilizing. | This product is generally applied toprosthetic procedure foroverdentures.It is inserted into the O-ring RetainerCap and serves as a buffer for studtype abutment and denturestabilizing. | This product is generally applied toprosthetic procedure foroverdentures.It is inserted into the O-ring RetainerCap and serves as a buffer for studtype abutment and denturestabilizing. | |
| Substantial Equivalence Discussion | ||||
| 1.SimilaritiesThe subject device has similar characteristic for the following compared to the predicate devices. | ||||
| Meg-Loc Abutment● | ||||
| Subject Device | Predicate Device | Reference Device | Reference Device | |
| 510(k) No. | K192614 | K182091 | K123988 | K151789 |
| Device | Meg-Loc Abutment | Port Abutment | Meg-Rhein Abutment | LOCATOR F-Tx |
| Name | For Meg-Ball AttachmentSystem, Meg-Loc Abutment,Meg-Magnet Abutment | For Osstem AbutmentSystem | For AnyOne™ InternalImplant System | For LOCATOR F-TxAttachment System |
| Manufacturer | MegaGen ImplantCo., Ltd. | Osstem ImplantCo., Ltd. | MegaGen ImplantCo., Ltd. | Zest Anchors, LLC |
| Indications forUse Statement | The Meg-Ball AttachmentSystem, Meg-LocAbutment, Meg-MagnetAbutment is intended to beused in the upper or lowerjaw and used forsupporting toothreplacements to restorechewing function. Intendedfor fully edentulous jawretaining a tissue supportedoverdenture.The abutments incombination withendosseous implants areused as the foundation foranchoring toothreplacements in either jaw.The attachments are used infixed overdenturerestorations that can beattached with a snap-insystem. | Osstem Abutment Systemis intended for use with adental implant to providesupport for Prostheticrestorations such as crowns,bridges, or overdentures. | The AnyOne InternalImplant System is intendedto be surgically placed inthe maxillary or mandibularmolar areas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 6.0 mm)are dedicated for immediateloading when good primarystability is achieved andwith appropriate occlusalloading. Larger implantsare dedicated for the molarregion and are indicated fordelayed loading. | The LOCATOR® F-TxAttachment System isdesigned to support fixed,partial or full archrestorations on endosseousdental implants in themandible or maxilla for thepurpose of restoringmasticatory function. It isused in fixed hybridrestorations that can beattached with asnap-in system. |
| Design | ||||
| Diameter | 3.89 mm | 3.5, 3.7, 4.1, 4.8, 5.1 mm | 3.4 mm | 3.0 mm to 7.0 mm |
| GingivalHeight | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8,5.8mm | 1, 2, 3, 4, 5, 6, 7 mm | 0.3, 1.3, 3.3, 5.3mm | 1, 2, 3, 4, 5, 6 mm |
| Total Length | 6.85, 7.35, 7.45, 7.95,8, 8.1, 8.35, 8.5, 8.6,8.95, 9.35, 9.5, 9.6,9.95, 10.35, 10.5, 10.6,10.95, 11.35, 11.5, 11.6,11.95, 12.35, 12.5, 12.6,12.95, 13.5, 13.6 | Unknown | 8.4, 8.9, 9.9, 10.9, 11.9,12.9, 13.9 | Unknown |
| CompatibleImplantSystem | AnyRidge InternalImplant SystemAnyOne Internal ImplantSystemAnyRidge Octa 1 ImplantSystemExFeel Internal ImplantSystem | TS SA Fixture SystemSS SA Fixture SystemUS SA Fixture SystemMS SA Implant System | AnyOne Internal ImplantSystem | Astra TechBioHorizonsBiomet 3iCamlogDentsplyMIS ImplantsNobel BiocareStraumannZimmer |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| SurfaceTreatment | Machined surface | Partial TiN coating | Machined surface | TiCN or TiN coating |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| AbutmentAngle | Straight | Straight | Straight | Straight |
| Principle ofOperation | This product is generallyapplied to prosthetic | This product is generallyapplied to prosthetic | This product is generallyapplied to prosthetic | This product is generallyapplied to prosthetic |
| procedure foroverdentures.The head part is whereconnected to overdenturewith attachment and thescrew part is connected | procedure foroverdentures.The head part is whereconnected to overdenturewith attachment and thescrew part is connected | procedure foroverdentures.The head part is whereconnected to overdenturewith attachment and thescrew part is connected | procedure foroverdentures.The head part is whereconnected to overdenturewith attachment and thescrew part is connected | |
| directly to the endosseousdental implant by theirthreaded part. | directly to the endosseousdental implant by theirthreaded part. | directly to the endosseousdental implant by theirthreaded part. | directly to the endosseousdental implant by theirthreaded part. | |
| Substantial Equivalence Discussion | ||||
| 1. | SimilaritiesThe subject device has similar characteristic for the following compared to the predicate/reference devices.- Design, Material, Surface Treatment, Sterilization, Angle and Principle of Operation | |||
| 2. | DifferencesThe subject device has the different characteristic for the following compared to the predicate/reference devices.- Indications for Use - See Section 7 (page 4/13)- Diameter and Gingival Height- The diameter of subject device is slightly different with predicate/reference devices however the subject device lies within therange of the predicate device. The gingival height range of the subject device is slightly different with predicate/referencedevices however the subject device lies within the combined range of the predicate/reference devices. Also, these differencesdo not cause a matter in substantial equivalence since size difference is minor. | |||
| 3. | DiscussionIn order to demonstrate the differences do not raise an issue in substantial equivalence, each performance test on the subjectand predicate device have been performed to figure out physical property (e.g. retentive force) with appropriate attachment asintended. 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 theoverdenture that means load is dispersed to the full denture. The test result shows that the performance of subject device isverified and 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 havein common in indication for use, design, material, function; and the differences have been identifiedvia the performance test and the differences do not impact substantial equivalence. |
Discussion 3.
In order to demonstrate the difference does not raise an issue 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 abutment as intended. 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.
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• Retentive Ring
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
The diameter of subject device is slightly different with predicate devices; there is a 0.1mm difference between reference device and the subject device lies within the combined range of the predicate devices and reference device. This difference does not cause a matter in substantial equivalence since the size difference is minor.
-Material
The material of subject device is different with predicate devices but the biocompatibility testing has been performed in accordance with ISO 10993-1.
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 and abutment as intended. The biocompatibility test has been conducted as well for demonstrating the substantial equivalence of the material difference. The tests result show that the performance and biocompatibility of subject device support 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, function, etc.; and the differences have been identified via the tests and do not impact substantial equivalence.
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10/13Pages
K192614
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| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) No. | K192614 | K162867 |
| Device Name | Meg-Magnet AbutmentFor Meg-Ball Attachment System, Meg-Loc Abutment,Meg-Magnet Abutment | MagDen Mini Abutmentfor MagDen Dental Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | SHINHUNG MST Co., Ltd. |
| Indications for Use Statement | The Meg-Ball Attachment System, Meg-LocAbutment, Meg-Magnet Abutment is intended to beused in the upper or lower jaw and used forsupporting tooth replacements to restore chewingfunction. Intended for fully edentulous jaw retaininga tissue supported overdenture. The abutments incombination with endosseous implants are used asthe foundation for anchoring tooth replacements ineither jaw. The attachments are used in fixedoverdenture restorations that can be attached with asnap-in system. | The MagDen Dental Implant System is intended tobe surgically placed in the bone of the upper orlower jaw arches to provide support for prostheticdevices, such as artificial teeth, and to restore thepatient's chewing function. |
| Design | Image: Meg-Magnet Abutment design | Image: MagDen Mini Abutment design |
| Diameter | 4.5, 5.0mm | 3.8, 4.0, 4.2 mm |
| Gingival Height | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8mm | Not Known |
| Total Length | 5.65, 5.85, 6.15, 6.75, 6.8, 6.9, 7.15, 7.3, 7.4,7.75, 8.15, 8.3, 8.4, 8.75, 9.15, 9.3, 9.4, 9.75,10.15, 10.3, 10.4, 10.75, 11.3, 11.4 | 4.3, 4.8, 5.3, 5.5, 5.8, 6.0, 6.3, 6.5, 6.8, 7.0, 7.3,7.5, 7.8, 8.0, 8.5, 9.0 |
| Compatible Implant System | AnyRidge Internal Implant SystemAnyOne Internal Implant SystemAnyRidge Octa 1 Implant SystemExFeel Internal Implant System | MagDen Dental Implant System |
| Material | Stainless Steel | Stainless Steel |
| Surface Treatment | TiN coating | TiN coating |
| Sterilization | Non-sterile | Non-sterile |
| Abutment Angle | Straight | Straight |
| Principle of Operation | This product is generally applied to prostheticprocedure for overdentures. The head part is whereconnected to overdenture with attachment and thescrew part is connected directly to the endosseousdental implant by their threaded part. | This product is generally applied to prostheticprocedure for overdentures. The head part is whereconnected to overdenture with attachment and thescrew part is connected directly to the endosseousdental implant by their threaded part. |
| Substantial Equivalence Discussion | ||
| 1. SimilaritiesThe subject device has similar characteristic for the following compared to the predicate device.Design, Material, Surface Treatment, Sterilization, Angle and Principle of Operation. | ||
| 2. DifferencesThe subject device has the different characteristic for the following compared to the predicate device.- Indications for Use – See Section 7 (page 4/13)- DiameterThe diameter of subject device is slightly larger than predicate device, however it does not cause a matter insubstantial equivalence since the size difference is minor. | ||
| 3. DiscussionIn order to demonstrate the difference does not raise an issue in substantial equivalence, each performance teston 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 Documentbeing as proposed abutments is straight type. The subject abutment is intended for straightimplantation, and is not received single load, because it used for supporting the overdenture that means load is |
Meg-Magnet Abutment .
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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.
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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" for the Retentive Ring and Meg-Magnet Abutment. Cytotoxicity Test - ISO 10993-5
Oral Mucosa Irritation Test - ISO 10993-10
Skin Sensitization Test - ISO 10993-10
Acute Systemic Toxicity Test - ISO 10993-11
The biocompatibility testing for the Meg-Loc Abutment, Meg-Ball Abutment and Metal Cap is leveraged from the AnyOne Internal Implant System (K123988) since these have same material composition, manufacturing process and patient contacting parts as predicate devices.
Modified Surface Treatment
The surface treatment evaluation has been performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to evaluate the TiN coated device:
- · Surface Cross section & Coating Thickness Analysis, Component Analysis, Adhesion Grade Analysis
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>.
Sterilization validation
The subject device is supplied in non-sterile state. Sterilization validating testing for steam sterilization by the user has been performed in accordance with ISO 11137 and ISO 17665-1, 2 to verify the sterility assurance level (10-6).
Performance (Physical Properties) Test
The bench tests including retentive force have been performed in accordance with 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to evaluate the performance of the subject devices. The retention testing for dental attachment has been conducted as well.
9. Summary of Clinical Testing
No clinical studies are submitted.
10. Conclusion
Based on the information provided in this premarket notification, We, MegaGen Implant Co., Ltd. conclude that the Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is substantially equivalent to the predicate device as herein.
§ 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.)