Internal Hex Implant System

K190837 · Ebi, Inc. · DZE · Jan 22, 2020 · Dental

Device Facts

Record IDK190837
Device NameInternal Hex Implant System
ApplicantEbi, Inc.
Product CodeDZE · Dental
Decision DateJan 22, 2020
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Internal Hex Implant System is intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. For implant bodies Ø4.1 and greater, the Internal Hex Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implant bodies with a diameter less than Ø4.1 are intended for immediate loading when using a minimum of 4 implants with lengths >8mm.

Device Story

Internal Hex Implant System comprises endosseous dental implant fixtures and various abutments; used for tooth replacement in edentulous or partially edentulous patients. Fixtures are placed in maxillary or mandibular arches; support crowns, bridges, or overdentures. System supports immediate or early loading, and one or two-stage surgical protocols. Fixtures feature internal hex connection and SLA surface treatment. Abutments connect to fixtures to support prosthetic restorations. Device used in dental clinics by trained clinicians. Output is a stable foundation for dental prosthetics, restoring masticatory function and aesthetics. Benefits include improved patient quality of life through tooth replacement.

Clinical Evidence

Bench testing only. Included fatigue testing per ISO 14801:2016, cytotoxicity testing per ISO 10993-5, and end-user sterilization validation per ISO 17665-1. Biocompatibility, shelf-life (ASTM F1980-07), and bacterial endotoxin data were leveraged from predicate/reference devices.

Technological Characteristics

Endosseous root-form dental implants. Materials: Pure Titanium Grade 4 (ASTM F67) for fixtures; Ti-6Al-4V ELI Alloy (ASTM F136) for abutments; POM for plastic cylinders. Surface: SLA (Sandblast, Large grit Acid etched). Connection: Internal Hex. Dimensions: Fixture diameters 3.25-5.5mm, lengths 7-18mm. Sterilization: Radiation (fixtures), non-sterile (abutments, requires end-user sterilization).

Indications for Use

Indicated for edentulous or partially edentulous patients requiring maxillary or mandibular arch dental implants to support crowns, bridges, or overdentures. Immediate loading indicated for implants ≥Ø4.1 with good primary stability and appropriate occlusal loading; or for implants <Ø4.1 when using ≥4 implants with lengths >8mm.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 22, 2020 EBI Inc. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620 Re: K190837 Trade/Device Name: Internal Hex Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 16, 2019 Received: December 23, 2019 Dear April Lee: 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 (OS) 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. for 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190837 Device Name Internal Hex Implant System #### Indications for Use (Describe) The Internal Hex Implant System is intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. For implant bodies Ø4.1 and greater, the Internal Hex Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implant bodies with a diameter less than Ø4.1 are intended for immediate loading when using a minimum of 4 implants with lengths >8mm. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary ### Submitter EBI Inc. DongJun Yang 124, Uisong-gil, Amnyang-myeon, Gyeongsan-si Gyeongsangbuk-do, 38493 Republic of Korea Email: sas@ebiimplant.com Tel. +82-53-817-7767 Fax. +82-53-817-7768 ## Device Information - Trade Name: Internal Hex Implant System ● - Common Name: Dental Implant System - Classification Name: implant, endosseous, root-form - Primary Product Code: DZE ● - Secondary Product Code: NHA - . Panel: Dental - Regulation Number: 21 CFR 872.3640 - . Device Class: Class II - Date Prepared: 01/21/2020 ● ### Predicate Devices: The subject device is substantially equivalent to the following predicate device: Primary Predicate - . K170031, Internal Octa Implant System manufactured by EBI Inc. ### Reference Device - K042971, TITAN Dental Implant System by Titan Implant Inc. ● - . K063286, OSSEOTITE: OSSEOTITE NT: TG OSSEOTITE by Implant Innovations, inc. - K073116, EBI Internal Implant System by EBI Inc. ● - K113554, CMI Implant System by Neobiotech Co., Ltd. - . K121585, TS IMPLANT SYSTEM by Osstem Implant Co., Ltd. - K140091, Xpeed AnyRidge Internal Implant System by Megagen Implant Co., Ltd. ● - K142426, EBI External Implant System by EBI Inc. - K162099, IBS Implant System II by InnoBioSurg Co., Ltd. - K163349, MIS V3 Conical Connection Dental Implant System by MIS Implants Technologies Ltd. - K181138. IS-III Active System by Neobiotech Co., Ltd. - K190849, IS-III active System_S-narrow Type by Neobiotech Co., Ltd. ● - . K173701, Implant-One™ System by Implant Logistics, Inc. - K190552, JJ Implant System by JJ Implants ● ### Device Description: The subject endosseous dental implant bodies are composed of Pure Titanium Grade 4. Internal Hex Implant System has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placements. Internal Hex Implant Systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The Internal Hex Implant System has an internal connection. The surface of the implant bodies has been treated with SLA (Sandblast, Large grit Acid etched). {4}------------------------------------------------ The system consists of BLT II OS Implant Fixtures and various abutments such as Cover Screw, Healing abutment, BestDuo Abutment, BestSolid Abutment, BestOcta Abutment, BestAngled Abutment, Temporary Abutment, Octa Plastic Cylinder, Denture Abutment, Multi-Unit Abutment, Multi-unit Abutment Screw, Multi-Unit Healing Cap, Multi-Unit Temporary Cylinder, Multi-Unit Cylinder Screw and Abutment Screw. | Fixture | Connection<br>Platform Type | Body Diameter (Ø) | Length (mm) | |-------------------------|-----------------------------|-------------------|--------------------------------------------------------------------------------------------------------------------------| | BLT II<br>OS<br>Implant | Hex 2.1 | 3.25mm | 7.2,7.7,8.2,8.7,9.2,9.7,10.2,10.7,11.2,11.7,12.2,12.7,<br>13.2,13.7,14.2,14.7,15.2,15.7 | | | Hex 2.1 | 3.25mm (Tapered) | 7.0.7.2.7.7,8.2,8.5,8.7.9.2.9.7,10.0.10.2.10.7,11.2.11.5.11.7,12.2.<br>12.7,13.0.13.2.13.7,14.2.14.7,15.0.15.2.15.7,18.0 | | | Hex 2.5 | 3.7 mm | 7.2,7.7,8.2,8.7,9.2,9.7,10.2,10.7,11.2,11.7,12.2,12.7,<br>13.2,13.7,14.2,14.7,15.2,15.7 | | | Hex 2.5 | 3.7 mm (Tapered) | 7.0.7.2.7.7,8.2,8.5,8.7.9.2.9.7,10.0.10.2.10.7,11.2.11.5.11.7,12.2.<br>12.7,13.0.13.2.13.7,14.2.14.7,15.0.15.2.15.7,18.0 | | | Hex 2.5 | 4.1 mm | 7.2,7.7,8.2,8.7,9.2,9.7,10.2,10.7,11.2,11.7,12.2,12.7,<br>13.2,13.7,14.2,14.7,15.2,15.7 | | | Hex 2.5 | 4.1 mm (Tapered) | 7.0.7.2.7.7,8.2,8.5,8.7.9.2.9.7,10.0.10.2.10.7,11.2.11.5.11.7,12.2.<br>12.7,13.0.13.2.13.7,14.2.14.7,15.0.15.2.15.7,18.0 | | | Hex 2.5 | 4.5 mm | 7.2,7.7,8.2,8.7,9.2,9.7,10.2,10.7,11.2,11.7,12.2,12.7,<br>13.2,13.7,14.2,14.7,15.2,15.7 | | | Hex 2.5 | 4.5 mm (Tapered) | 7.0.7.2.7.7,8.2,8.5,8.7.9.2.9.7,10.0.10.2.10.7,11.2.11.5.11.7,12.2.<br>12.7,13.0.13.2.13.7,14.2.14.7,15.0.15.2.15.7,18.0 | | | Hex 2.5 | 4.8 mm | 7.2,7.7,8.2,8.7,9.2,9.7,10.2,10.7,11.2,11.7,12.2,12.7,<br>13.2,13.7,14.2,14.7,15.2,15.7 | | | Hex 2.5 | 4.8 mm (Tapered) | 7.0.7.2.7.7,8.2,8.5,8.7.9.2.9.7,10.0.10.2.10.7,11.2.11.5.11.7,12.2.<br>12.7,13.0.13.2.13.7,14.2.14.7,15.0.15.2.15.7,18.0 | | | Hex 2.5 | 5.5 mm | 7.2,7.7,8.2,8.7,9.2,9.7,10.2,10.7,11.2,11.7,12.2 | | | Hex 2.5 | 5.5 mm (Tapered) | 7.0.7.2.7.7,8.2,8.5,8.7.9.2.9.7,10.0.10.2.10.7,11.2.11.5.11.7,12.2. | The ranges of the dimensions of Fixtures are below: The Fixtures are supplied sterile. The ranges of the dimensions of Abutments are below: | Abutment | Uses | Connection Platform<br>Type and size | Diameter<br>(Ø) | Length (mm) | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|----------------------------|----------------------------------------| | Cover Screw | It is used for protecting inner hole and<br>connecting part with exposed upper part<br>of structure during the healing period after<br>inserting dental implant fixture. | Mini: Hex 2.1<br>Regular: Hex 2.5 | 3.0, 3.2, 3.6 | Gingival height:<br>0.4, 1.25, 2.25 | | Healing Abutment | It is used to formation appropriate<br>gingival shape during the soft tissue<br>healing period combined with implant. | Mini: Hex 2.1<br>Regular: Hex 2.5 | 3.5, 4.0, 4.8,<br>5.5, 6.5 | Gingival height:<br>1.0, 2.0, 3.0, 4.0 | | BestDuo Abutment | The Abutment is connected with fixture<br>and it supports prosthesis which restores<br>tooth function. | Mini: Hex 2.1<br>Regular: Hex 2.5 | 3.5, 4.0, 4.8,<br>5.5, 6.5 | Post Height:<br>5.2, 7.2 | | BestSolid<br>Abutment | The Abutment is connected with fixture<br>and it supports prosthesis which restores<br>tooth function. | Mini: Hex 2.1<br>Regular: Hex 2.5 | 3.5, 4.0, 4.8,<br>5.5, 6.5 | Post Height:<br>4.2, 4.5, 7.2, 7.5 | {5}------------------------------------------------ | BestOcta Abutment | The Abutment is connected with fixture<br>and it supports prosthesis which restores<br>tooth function. | Mini: Hex 2.1<br>Regular: Hex 2.5 | 3.5, 4.8 | Post Height:<br>2.15 | |-------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------|----------------|----------------------------------------------------------| | BestAngled<br>Abutment | The Abutment is connected with fixture<br>and it supports prosthesis which restores<br>tooth function. | Mini: Hex 2.1<br>Regular: Hex 2.5 | 3.5, 4.0, 4.8 | Post Height:<br>7.7 | | Temporary<br>Abutment | It is used as the abutment for temporary<br>prosthetics. | Mini: Hex 2.1<br>Regular: Hex 2.5 | 4.0, 4.8 | Post Height:<br>7.2 | | Octa Plastic<br>Cylinder | It is used as a model for casting and burn-<br>out. | Mini: Hex 2.1<br>Regular: Hex 2.5 | 5.0 | 10.0 | | Denture Abutment | It is used to connect the denture to<br>implant. | Mini: Hex 2.1<br>Regular: Hex 2.5 | 3.75, 4.0, 4.8 | Post Height:<br>1.8 | | Multi-Unit<br>Abutment | It is used to correct the angle between<br>implant and crown and connects them. | Mini: Hex 2.1<br>Regular: Hex 2.5 | 4.8 | Gingival height:<br>1.0, 2.0, 2.5, 3.0,<br>3.5, 4.0, 5.0 | | Multi-Unit<br>Abutment Screw | It is used to connect and fix the abutment<br>to the fixture tightly. It makes the<br>abutment act as a crown. | Mini: Hex 2.1<br>Regular: Hex 2.5 | 2.0 | 1.55 | | Multi-Unit Healing<br>Cap | It prevents the contamination of Multi-<br>Unit Abutment | Mini: Hex 2.1<br>Regular: Hex 2.5 | 4.9, 6.2 | $∅4.9:4.2$<br>$∅6.2:4.2$ | | Multi-Unit<br>Temporary<br>Cylinder | It acts as a pillar of a temporary<br>prosthetic. | Mini: Hex 2.1<br>Regular: Hex 2.5 | 4.8 | 12 | | Multi-Unit<br>Cylinder Screw | It is used to connect and fix the Multi-Unit<br>Cylinder to the abutment tightly | Mini: Hex 2.1<br>Regular: Hex 2.5 | 3.4 | 2.0 | | Abutment Screw | It is used to connect and fix the abutment<br>to the fixture tightly. | Mini: Hex 2.1<br>Regular: Hex 2.5 | 2.25 | 2.0 | Tolerance of dimension for Abutments shall be within ± 1% range. The abutments are supplied nonsterile and must be sterilized before use. ## Indications for Use: The Internal Hex Implant System is intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. For implant bodies Ø4.1 and greater, the Internal Hex Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implant bodies with a diameter less than Ø4.1 are intended for immediate loading when using a minimum of 4 implants with length >8mm. ## Materials: - . The endosseous dental implant bodies and Multi-Unit Temporary Cylinder are fabricated from Pure Titanium Grade 4 that conforms to ASTM F67. - . Cover Screw, Healing Abutment, BestDuo Abutments, BestSolid Abutment, BestOcta Abutment, BestAngled Abutment, Temporary Abutment, Denture Abutment, Multi-Unit Abutment, Multi-Unit Abutment Screw, Multi-Unit Healing Cap, Multi-Unit Cylinder Screw, and Abutment Screw are fabricated from Ti-6Al-4V ELI Alloy that conforms to ASTM F136. - Octa Plastic Cylinder is fabricated from POM. . {6}------------------------------------------------ # Summary of Technological Characteristics # 1) Fixtures | | Subject Device | Primary Predicate | Reference Device | Reference Device | |--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | EBI Inc. | EBI Inc. | IMPLANT INNOVATIONS, INC. | JJ Implants | | Device Name | Internal Hex Implant<br>System | Internal Octa Implant<br>System | OSSEOTITE; OSSEOTITE NT; XP;<br>TG OSSEOTITE | JJ Implant System: Genesis Active<br>and Genesis Normo | | 510(k) Number | K190837 | K170031 | K063286 | K190552 | | Device Classification<br>Name | Implant, Endosseous,<br>Root-form | Implant, Endosseous,<br>Root-form | Implant, Endosseous, Root-form | Implant, Endosseous, Root-form | | Classification Product<br>Code | DZE, NHA | DZE | DZE | DZE, NHA | | Regulation Number | 21 CFR872.3640 | 21 CFR872.3640 | 21 CFR872.3640 | 21 CFR872.3640 | | Indications for Use | The Internal Hex Implant System is<br>intended for placement in the<br>maxillary and/or mandibular arches to<br>support crowns, bridges, or<br>overdentures in edentulous or<br>partially edentulous patients. For<br>implant bodies Ø4.1 and greater, the<br>Internal Hex Implant System is<br>intended for immediate loading when<br>good primary stability is achieved and<br>with appropriate occlusal loading.<br>Implant bodies with a diameter less<br>than Ø4.1 are intended for immediate<br>loading when using a minimum of 4<br>implants with length >8mm. | The Internal Octa Implant System is<br>intended for placement in the<br>maxillary and/or mandibular arches to<br>support crowns, bridges, or<br>overdentures in edentulous or<br>partially edentulous patients. The<br>Internal Octa Implant System is<br>intended for immediate loading when<br>good primary stability is achieved and<br>with appropriate occlusal loading. | 3i dental implants are intended for<br>surgical placement in the upper or<br>lowerjaw to provide a means for<br>prosthetic attachment in single tooth<br>restorations and in partially or fully<br>edentulous spans with multiple single<br>teeth, or as a terminal or intermediary<br>abutment for fixed or removable<br>bridgework, and to retain<br>overdentures. In addition, when a<br>minimum of 4 implants, > 10mm in<br>length, are placed in the mandible and<br>splinted in the anterior region,<br>immediate loading is indicated. | JJ Implant System Genesis Active<br>implants and Genesis Normo<br>implants are indicated for placement<br>in the maxillary or mandibular arch<br>to provide support for single-unit or<br>multi-unit restorations for<br>functional and esthetic<br>rehabilitation. JJ Implant System<br>Genesis Active implants and<br>Genesis Normo<br>implants are indicated for<br>immediate loading when good<br>primary stability is achieved and the<br>occlusal<br>loading is appropriate.<br>JJ Implant System Mini implants<br>may be used for denture<br>stabilization using multiple implants<br>in the anterior mandible and the<br>anterior maxilla, and are indicated<br>for immediate loading when good<br>primary stability is achieved and the<br>occlusal loading is appropriate. | | Material | Pure Titanium Gr.4 | Pure Titanium Gr.4 | Pure Titanium Gr.4 | Ti-6Al-4V alloy | | Design | Image: Implant | Image: Implant | Image: Implant | Image not available;<br>Endosseous root-form,<br>threaded | | Body Diameters | 3.25-5.5mm | 4.1, 4.8mm | 3.25, 3.75, 4.0,<br>6.0mm | 3.0 - 5.2mm | | Neck Diameter | 3.4-5.5mm | 4.1, 4.8mm | 3.25-6.0mm | 3.0 - 4.7mm | | Implant Lengths | 7-18mm | 7.2-14.2 mm | 7-20mm | Ø3.0, 5.0, 3.2, 4.7: 8-13mm | | | | | | Ø3.5 - 4.2: 8-16 mm<br>Ø5.2: 8 - 11.5 mm | | Connection Type | Internal Hex | Internal Octa | External Hex | Internal Hex | | Surface Treatment | SLA | SLA | Full OSSFOTITE | RBM | | Gamma Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Radiation Sterile | | Implant Type | Bone Level | Bone Level | Bone Level | Bone Level | | Similarities | The indications for use, material, surface treatment, application method, sterilization method, general shape design and dimensions are similar between subject<br>device and the Primary predicate. Further reference devices used for technological comparisons of Internal Hex Implant System do not include any component-<br>specific language that would raise any concern related to the substantial equivalence of the subject devices and need to be included in the Indications for Use. | | | | | Differences | 1) Indications for Use: Based on the sizes for the reference devices K063286 and K190552, the subject Indications for Use were revised as compared to the<br>primary predicate.<br>2) Connection Type: The primary predicate, K170031 is Octa connection platform type and the subject device is Hex connection platform type. This<br>difference of the connection platform type does not impact substantial equivalence because we have addressed this difference by providing recommended<br>descriptive information and non-clinical testing.<br>3) Dimensions: Another major difference between subject and primary predicate is dimensions. To support implants with a length of 7 mm for all diameters,<br>implants with a diameter of 3.25 and 5.5mm at proposed lengths and implants with lengths of 15.7-18mm for diameter 3.25-4.8mm, we chose K063286 and it<br>demonstrated that it is substantially equivalent. | | | | {7}------------------------------------------------ K190837 ## 2) Abutments <Cover Screw> | | Subject Device | Reference Device | Reference Device | |---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------------------------| | Company | EBI Inc. | EBI Inc. | OSSTEM IMPLANT CO.,LTD | | Device Name | Internal Hex Implant System | EBI Internal Implant System | TS IMPLANT SYSTEM | | 510(k) Number | NA | K073116 | K121585 | | Material | Ti-6Al-4V ELI Alloy | Ti-6Al-4V ELI Alloy | Titanium Alloy | | Design | Image: Subject Device Design | Image: Reference Device Design | Image: Reference Device Design | | Diameters (Ø) | 3.0, 3.2, 3.6 | 3.5, 4.3, 6.0 | 3.0, 3.2, 3.6 | | Lengths(mm) | 0.4, 1.25, 2.25 | 0.55, 1.5, 3.0 | 0.4, 2.0 | | Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | | Similarities | The subject and reference devices have similar indications for use, functions, materials, surface treatment, general shape (design) and<br>dimensions. | | | | Differences | As the primary predicate, K170031 does not include the cover screw, we chose K073116 and K121585 as Reference Device.<br>K073116 was chosen to support the material, indications for Use, and shelf life and K121585 was chosen to support the dimensions.<br>Any difference doesn't impact the substantial equivalence. | | | ## <Healing Abutment> | | Subject Device | Reference Device | Reference Device | |-------------|-----------------------------|-----------------------------|-----------------------------| | Company | EBI Inc. | EBI Inc. | TITAN IMPLANT INC | | Device Name | Internal Hex Implant System | EBI External Implant System | TITAN Dental Implant System | {8}------------------------------------------------ K190837 | 510(k) Number | NA | K142426 | K042971 | | |------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------|--| | Material | Ti-6Al-4V ELI Alloy…
Innolitics
510(k) Summary
Decision Summary
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