Multi-unit Abutment, Multi-unit Angled Abutment

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 20, 2021 MegaGen Implant Co. Ltd. % You Kim Chief Researcher DaeGyeong Regulatory Affairs Institute 32, Innovalley-ro Daegu, Dong-gu 41065 REPUBLIC OF KOREA Re: K203808 Trade/Device Name: Multi-unit Abutment, Multi-unit Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 9, 2021 Received: September 22, 2021 Dear You 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 mediation-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, for Andrew 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 {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K203808 Device Name Multi-unit Abutment, Multi-unit Angled Abutment Indications for Use (Describe) The Multi-unit Abutment, Multi-unit Angled Abutment is intended to the maxillary or mandbular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | <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. 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Submission Correspondent You Jung Kim DaeGyeong Regulatory affairs Institute 32, Innovalley-ro, Dong-gu, Daegu, 41065, Republic of Korea Tel: +82-53-247-2258 Fax: +82-53-247-2254 Email: ra3@dgri.co.kr ## 3. Device - Multi-unit Abutment, Multi-unit Angled Abutment Trade Name: - Endosseous Dental Implant Abutment Common Name: - . Classification Name: Endosseous dental implant abutment - Classification Product Code: NHA - . Classification regulation: Class II, 21 CFR 872.3630 ## 4. Predicate Device - . Primary Predicate Device: K182448 – AnyRidge Octa 1 Implant System #### . Reference Devices: - K123988 AnyOne Internal Implant System K192401 - Straumann® Screw-Retained Abutments K201621 – Magicore II System K141457 – Dentium Implantium® and SuperLine® Abutments K110955 - AnyRidge Internal Implant System K171142 - Healing Cap Multi-Unit Titanium K052369 - ExFeel Dental Implant System {4}------------------------------------------------ ## 5. Description The Multi-unit Abutment, Multi-unit Angled Abutment of a dental implant system to provide support for prosthetic restorations. It is attached to the implants and intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore patient's chewing function. The Multi-unit Abutment, Multi-unit Angled Abutment consists of straight & angled abutments and prosthetic components in varying sizes for single & multiple unit screw retained restorations. The Multi-unit Abutment, Multi-unit Angled Abutment is compatible with following MegaGen Implants cleared under: | Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) | |---------------------------------|----------------------------------------------|---------------------------------------|--------------------|------------------|--------------------------------------------------------| | MegaGen<br>Implant Co.,<br>Ltd. | Xpeed AnyRidge<br>Internal Implant<br>System | Xpeed<br>AnyRidge<br>Internal Fixture | K123870<br>K140091 | Internal<br>Hex | 4.0, 4.4, 4.9, 5.4,<br>5.9, 6.4, 6.9, 7.4,<br>7.9, 8.4 | | | AnyOne<br>Internal Implant<br>System | AnyOne<br>Internal Fixture | K123988 | Internal<br>Hex | 3.9, 4.3, 4.8, 5.3,<br>5.8, 6.3, 6.8, 7.3,<br>7.8, 8.3 | | | AnyRidge Octa 1<br>Implant System | AnyRidge Octa<br>1 Fixture | K182448 | Internal<br>Octa | 3.6, 3.7, 4.0, 4.1,<br>4.4, 4.8, 5.0, 5.5 | The Multi-unit Abutment, Multi-unit Angled Abutment is consisted of the following devices. | | Device | | Content | |-------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Abutment | Multi-unit Abutment | Description The Multi-unit Abutment is used for fabricating screw-retained prosthesis. There are two types of Multi-unit Abutments, N type and S type, depending on the connection type and prosthetics compatibility. The N type (one-piece type) is screwed directly in to the endosseous dental implant by their lower threaded part, and the S type (two-piece type) is connected the fixture with Multi-unit Abutment Screw. | | | | Material | Ti-6Al-4V ELI (ASTM F136-13) | | | | Dimension (Diameter & Total Length) | $\varnothing$ 4.8 x 8.05, 8.75, 8.94, 9.10, 9.75, 9.80, 9.84, 10.75, 10.80, 10.84, 11.75, 11.80, 11.84, 12.80, 12.84mm<br>$\varnothing$ 5.0 x 6.2, 7.2, 8.2, 9.2, 10.2 mm | | | | Post Heights | 1.8, 2.2 mm | | | | Gingival Heights | 0.6, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5 mm | | | | Angulation | Straight | | | | Compatible Implant System | Xpeed AnyRidge Internal Implant System<br>AnyOne Internal Implant System<br>AnyRidge Octa 1 Implant System | | | | Multi-unit Angled Abutment | Description The Multi-unit Angled Abutment is used for fabricating screw-retained prosthesis and correcting the prosthetic angulation of implant. There are two types of Multi-unit Angled Abutments, N type and S type, depending on the prosthetics compatibility. The N type (two-piece type) is connected the fixture with Multi-unit Abutment Screw, and the S type (two-piece type) is connected the fixture with Abutment Screw or Multi Post Screw. | | | | Material | Ti-6Al-4V ELI (ASTM F136-13) | | | | Dimension (Diameter & Length) | $\varnothing$ 4.8 x 3.4, 3.9, 3.94, 4.35, 4.4, 4.9, 4.94, 5.35, 5.4, 5.85, 5.9, 5.94, 6.35, 6.4, 6.85, 6.9, 6.94, 7.35, 7.85, 8.85 mm<br>$\varnothing$ 5.0 x 4.5, 4.7, 5.5, 5.6, 5.7, 5.8, 6.5, 6.6, 6.7, 6.8, 7.5, 7.6, 7.7, | | | | | 7.8, 8.6, 8.8 mm | | | | Post Heights | 2.2, 3.9 mm | | | | Gingival Heights | 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, mm | | | | Angulation | 17°, 29°, 30° | | | | Compatible<br>Implant System | Xpeed AnyRidge Internal Implant System<br>AnyOne Internal Implant System<br>AnyRidge Octa 1 Implant System | | | Multi-unit<br>Abutment<br>Screw | Description | The Multi-unit Abutment Screw is used for connecting Multi-unit Abutment or Multi-unit Angled Abutment to the Fixture. | | | | Used with | Multi-unit Abutment (S type) in Xpeed AnyRidge & AnyOne<br>Multi-unit Angled Abutment (N type) in Xpeed AnyRidge & AnyOne<br>& AnyRidge Octa 1 | | | | Material | Ti-6Al-4V ELI (ASTM F136-13) | | | | Dimension<br>(Diameter &<br>Total Length) | Ø 2.1 x 7.0 mm<br>Ø 2.2 x 4.4 mm<br>Ø 2.4 x 6.8 mm<br>Ø 2.95 x 10.8, 11.5, 11.8, 12.5, 12.8, 13.5, 13.8, 14.5, 15.5 mm | | | | Compatible<br>Implant System | Xpeed AnyRidge Internal Implant System<br>AnyOne Internal Implant System<br>AnyRidge Octa 1 Implant System | | | Abutment<br>Screw | Description | The Abutment Screw is used for connecting Multi-unit Angled Abutment to the Fixture. | | | | Used with | Multi-unit Angled Abutment (S type) in AnyOne | | | | Material | Ti-6Al-4V ELI (ASTM F136-13) | | | | Dimension<br>(Diameter &<br>Total Length) | Ø 2.3 x 7.7 mm | | | | Compatible<br>Implant System | AnyOne Internal Implant System | | | Multi Post<br>Screw | Description | The Multi Post Screw is used for connecting Multi-unit Angled Abutment to the Fixture. | | | | Used with | Multi-unit Angled Abutment (S type) in Xpeed AnyRidge | | | | Material | Ti-6Al-4V ELI (ASTM F136-13) | | | | Dimension<br>(Diameter &<br>Total Length) | Ø 2.1 x 7.0 mm | | | | Compatible<br>Implant System | Xpeed AnyRidge Internal Implant System | | 2. Components | Healing Cap | Description | The Healing Cap is used for protecting Multi-unit (Angled) Abutment and minimizing irritation to tongue and oral mucosa during period of gingival healing.<br>It is connected to the Abutment using Cylinder Screw. | | | | Material | Ti-6Al-4V ELI (ASTM F136-13) | | | | Dimension<br>(Diameter & Length) | Ø 4.9 x 4.20 mm<br>Ø 6.8 x 4.20 mm | | | | Compatible<br>Implant System | Xpeed AnyRidge Internal Implant System<br>AnyOne Internal Implant System<br>AnyRidge Octa 1 Implant System | | | Temporary<br>Cylinder | Description | The Temporary Cylinder is used in conjunction with Multi-unit (Angled) Abutment to provide support for provisional restoration. It is connected to the Abutment using Cylinder Screw. | | | | Material | Ti-6Al-4V ELI (ASTM F136-13) | | | | Dimension<br>(Diameter & Length) | Ø 4.8 x 12.0 mm | | | Cuff Heights | 3.0 mm | | | | Angulation | Straight | | | | Compatible<br>Implant System | Xpeed AnyRidge Internal Implant System<br>AnyOne Internal Implant System<br>AnyRidge Octa 1 Implant System | | | CCM<br>Cylinder | Description | The CCM Cylinder is used in conjunction with Multi-unit<br>(Angled) Abutment to provide support for screw type final<br>prosthesis by casting with non-precious metal alloy (Co-Cr-Mo<br>Alloy). It is connected to the Abutment using Cylinder Screw. | | | | Material | Body: Co-Cr-Mo Alloy / Sleeve: POM | | | | Dimension<br>(Diameter & Length) | $Ø$ 4.8 x 13.0, 15.0 mm | | | | Post Height | 10.0, 13.0 mm | | | | Cuff Heights | 2.0, 3.0 mm | | | | Angulation | Straight | | | | Compatible<br>Implant System | Xpeed AnyRidge Internal Implant System<br>AnyOne Internal Implant System<br>AnyRidge Octa 1 Implant System | | | Cylinder<br>Screw | Description | The Cylinder Screw is used for connecting Multi-unit (Angled)<br>Abutment to Healing Cap, Temporary cylinder or CCM Cylinder. | | | | Material | Ti-6Al-4V ELI (ASTM F136-13) | | | | Dimension<br>(Diameter & Length) | $Ø$ 2.0 x 3.4 mm | | | | Compatible<br>Implant System | Xpeed AnyRidge Internal Implant System<br>AnyOne Internal Implant System<br>AnyRidge Octa 1 Implant System | | {5}------------------------------------------------ {6}------------------------------------------------ [Note 1] Some of devices described in this submission, Multi-unit Abutment and Multi-unit Abutment screw in AnyOne Internal Implant System had been FDA cleared with K123988, but it is being submitted to change their identifier without any modifications, and to add a new model. [Note 2] Some of devices described in this submission, Multi-unit Abutment, Multi-unit Angled Abutment and Multi-unit Abutment screw in AnyRidge Octa 1 Implant System had been FDA cleared with K182448, but it is being submitted to change their identifier with modification of surface treatment (Machined →Anodizing), and to add a new model. The changes are explained not affecting substantial equivalence in the part of 'VII. Substantial Equivalence Comparison'. {7}------------------------------------------------ ## 6. Indication for use The Multi-unit Abutment, Multi-unit Angled Abutment is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. ## 7. Basis for Substantial Equivalence The Multi-unit Abutment, Multi-unit Angled Abutment is substantially equivalent to the predicate devices in terms of indication for use, technical characteristic and function. They are made of the same material and have similar design. The size range of the subject device slightly differ from the predicate device however it is very minor not affecting substantial equivalence. The subject device is composed of the abutments and prosthetic components that are used for single & multiple unit screw retained restorations, while the predicate devices is addressed complete dental implant system including various fixtures and abutments. For this reason, the indication for use statement appear to be different between subject and predicate devices but proposed indication is available to apply to predicate devices as well, since the submission device is a sub-set of devices included in the predicate devices. Also, the point of those indications is ultimately identical in the way that all of devices in subject & predicate devices are intended to be provided the prosthetic support for dental restorations such as crown, bridges, and overdenture to restore patient's chewing function; and this is minor difference in wording not affecting the substantial equivalence of the subject device. Therefore, the indication for use of subject device is substantially equivalent to the predicate devices. The Indications for the subject device are identical except for the portion of K182448's indications that are specific to dental implant bodies, and this submission does not include any dental implant bodies, so the omission of this statement is acceptable. In order to demonstrate the difference in design does not raise any new issues, the performance test on the subject and predicate device have been performed in consideration of the worst case according to 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to figure out the physical property. The test result supports the substantial equivalence to the predicate device. 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 devices. {8}------------------------------------------------ ## Multi-unit Abutment | | Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | K203808 | K182448 | K123988 | K192401 | | | Device Name | Multi-unit Abutment<br>For Multi-unit Abutment,<br>Multi-unit Angled<br>Abutment | Multi-unit Abutment<br>For AnyRidge Octa 1 Implant<br>System | Multi-unit Abutment<br>For AnyOne Internal Implant<br>System | Straumann® Screw-<br>Retained Abutments | | | Manufacturer | MegaGen Implant Co.,<br>Ltd. | MegaGen Implant Co.,<br>Ltd. | MegaGen Implant Co.,<br>Ltd. | Straumann USA, LLC | | | Indications<br>for Use<br>Statement | The Multi-unit Abutment,<br>Multi-unit Angled<br>Abutment is intended to<br>be surgically placed in the<br>maxillary or mandibular<br>arches for the purpose<br>providing prosthetic<br>support for dental<br>restorations (Crown,<br>bridges, and overdentures)<br>in partially or fully<br>edentulous individuals. | The AnyRidge Octa 1<br>Implant System is intended<br>to be surgically placed in<br>the maxillary or<br>mandibular arches for the<br>purpose of providing<br>prosthetic support for<br>dental restorations (Crown,<br>bridges, and overdentures)<br>in partially or fully<br>edentulous individuals. It is<br>used to restore a patient's<br>chewing function in the<br>following situations and<br>with the clinical protocols:<br>-Delayed loading.<br>-Immediate loading when<br>good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. Larger implants<br>are dedicated for the molar<br>region. | The AnyOne Internal<br>Implant System is intended<br>to be surgically placed in<br>the maxillary or<br>mandibular molar areas for<br>the purpose providing<br>prosthetic support for<br>dental restorations (Crown,<br>bridges, and overdentures)<br>in partially or fully<br>edentulous individuals. It is<br>used to restore a patient's<br>chewing function. Smaller<br>implants (less than 6.0<br>mm) are dedicated for<br>immediate loading when<br>good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. Larger implants<br>are dedicated for the molar<br>region and are indicated<br>for delayed loading. | Prosthetic components<br>directly or indirectly<br>connected to the<br>endosseous dental implant<br>are intended for use as an<br>aid in prosthetic<br>rehabilitations. Temporary<br>components can be used<br>prior to the insertion of the<br>final components to<br>maintain, stabilize and<br>shape the soft tissue<br>during the healing phase;<br>they are to be placed out<br>of occlusion. Final<br>abutments may be placed<br>into occlusion for implants<br>with sufficient primary<br>stability or for implants<br>that are fully<br>osseointegrated.<br>Temporary Abutments<br>have a maximum duration<br>of usage of 180 days. | | | Design | Image: Multi-unit Abutment | Image: Multi-unit Abutment | Image: Multi-unit Abutment | Image: Screw-Retained Abutments | | | Diameter (Ø) | 4.8, 5.0 mm | 4.8 mm | 5.0 mm | 3.5, 4.6 mm | | | Total Length | 6.2, 7.2, 8.05, 8.2,<br>8.75, 8.94, 9.1, 9.2,<br>9.75, 9.8, 9.84, 10.2,<br>10.75, 10.8, 10.84,<br>11.75, 11.8, 11.84, 12.8,<br>12.84 mm | 9.8, 10.8, 11.8, 12.8<br>mm | 6.2, 7.2, 8.2, 9.2, 10.2<br>mm | Not Known | | | Post Height | 1.8, 2.2 mm | 2.2 mm | 1.8 mm | Not Known | | | Gingival<br>Height | 0.6, 1.5, 2.0, 2.5, 3.0,<br>3.5, 4.0, 4.5, 5.0, 5.5<br>mm | 1.3, 2.3, 3.3, 4.3 mm | 1.5, 2.5, 3.5, 4.5, 5.5<br>mm…