(296 days)
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.
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). 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.
Here's a breakdown of the acceptance criteria and study information for the EBI Inc. Internal Hex Implant System, as extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The documents describe the successful completion of various tests according to international and national standards. The acceptance criteria are implicitly that the device meets the respective standards and demonstrates substantial equivalence to predicate devices. The reported device performance is that it met these criteria.
| Test Type | Standard / Reference | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Fatigue Test | ISO 14801:2016, FDA Guidance (Class II Special Controls) | Device is strong enough for intended use under worst-case scenario | Met criteria; demonstrated substantial equivalence |
| Cytotoxicity Test | ISO 10993-5 | Non-cytotoxic | Met criteria; demonstrated biocompatibility and substantial equivalence |
| End User Sterilization Validation | ISO 17665-1:2006, -2:2009, ANSI/AAMI ST79 | Effective sterilization for end-user preparation | Met criteria |
| Biocompatibility Test | ISO 10993-1 | Biocompatible | Met criteria; demonstrated biocompatibility |
| Accelerated Aging Test (Shelf Life) | ASTM F1980-07 | Maintains performance over shelf life | Met criteria |
| Bacterial Endotoxin Test | USP <161> | Meets pyrogenicity limits | Met criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state numerical sample sizes for the test sets. However, it indicates these were non-clinical tests.
- Provenance: All tests mentioned are non-clinical (laboratory/bench testing). The document does not specify country of origin for the data, but the manufacturer is based in the Republic of Korea. The data is retrospective in the sense that the tests were performed and results analyzed for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. These are non-clinical engineering and biocompatibility tests against established standards. Ground truth is determined by the specific criteria outlined in the standards, not by expert consensus on interpretations of images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable, as ground truth is based on objective measurements and compliance with standard specifications rather than expert interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a dental implant system, not an AI-powered diagnostic tool. The submission focuses on the physical and biological properties of the implant and abutments.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests is based on:
- Engineering specifications and performance limits defined in international standards (e.g., ISO 14801:2016 for fatigue).
- Biocompatibility criteria established in ISO 10993 series and USP <161> for pyrogenicity.
- Sterilization efficacy criteria in ISO 17665-1:2006, -2:2009 and ANSI/AAMI ST79, and ISO 11137-1.2.3.
- Shelf life criteria in ASTM F1980-07.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not a machine learning model that requires a training set. The term "training set" is typically used in the context of AI/ML development.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and 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.
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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 (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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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).
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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 | ConnectionPlatform Type | Body Diameter (Ø) | Length (mm) |
|---|---|---|---|
| BLT IIOSImplant | Hex 2.1 | 3.25mm | 7.2,7.7,8.2,8.7,9.2,9.7,10.2,10.7,11.2,11.7,12.2,12.7,13.2,13.7,14.2,14.7,15.2,15.7 |
| Hex 2.1 | 3.25mm (Tapered) | 7.0.7.2.7.7,8.2,8.5,8.7.9.2.9.7,10.0.10.2.10.7,11.2.11.5.11.7,12.2.12.7,13.0.13.2.13.7,14.2.14.7,15.0.15.2.15.7,18.0 | |
| Hex 2.5 | 3.7 mm | 7.2,7.7,8.2,8.7,9.2,9.7,10.2,10.7,11.2,11.7,12.2,12.7,13.2,13.7,14.2,14.7,15.2,15.7 | |
| Hex 2.5 | 3.7 mm (Tapered) | 7.0.7.2.7.7,8.2,8.5,8.7.9.2.9.7,10.0.10.2.10.7,11.2.11.5.11.7,12.2.12.7,13.0.13.2.13.7,14.2.14.7,15.0.15.2.15.7,18.0 | |
| Hex 2.5 | 4.1 mm | 7.2,7.7,8.2,8.7,9.2,9.7,10.2,10.7,11.2,11.7,12.2,12.7,13.2,13.7,14.2,14.7,15.2,15.7 | |
| Hex 2.5 | 4.1 mm (Tapered) | 7.0.7.2.7.7,8.2,8.5,8.7.9.2.9.7,10.0.10.2.10.7,11.2.11.5.11.7,12.2.12.7,13.0.13.2.13.7,14.2.14.7,15.0.15.2.15.7,18.0 | |
| Hex 2.5 | 4.5 mm | 7.2,7.7,8.2,8.7,9.2,9.7,10.2,10.7,11.2,11.7,12.2,12.7,13.2,13.7,14.2,14.7,15.2,15.7 | |
| Hex 2.5 | 4.5 mm (Tapered) | 7.0.7.2.7.7,8.2,8.5,8.7.9.2.9.7,10.0.10.2.10.7,11.2.11.5.11.7,12.2.12.7,13.0.13.2.13.7,14.2.14.7,15.0.15.2.15.7,18.0 | |
| Hex 2.5 | 4.8 mm | 7.2,7.7,8.2,8.7,9.2,9.7,10.2,10.7,11.2,11.7,12.2,12.7,13.2,13.7,14.2,14.7,15.2,15.7 | |
| Hex 2.5 | 4.8 mm (Tapered) | 7.0.7.2.7.7,8.2,8.5,8.7.9.2.9.7,10.0.10.2.10.7,11.2.11.5.11.7,12.2.12.7,13.0.13.2.13.7,14.2.14.7,15.0.15.2.15.7,18.0 | |
| 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 PlatformType and size | Diameter(Ø) | Length (mm) |
|---|---|---|---|---|
| Cover Screw | It is used for protecting inner hole andconnecting part with exposed upper partof structure during the healing period afterinserting dental implant fixture. | Mini: Hex 2.1Regular: Hex 2.5 | 3.0, 3.2, 3.6 | Gingival height:0.4, 1.25, 2.25 |
| Healing Abutment | It is used to formation appropriategingival shape during the soft tissuehealing period combined with implant. | Mini: Hex 2.1Regular: Hex 2.5 | 3.5, 4.0, 4.8,5.5, 6.5 | Gingival height:1.0, 2.0, 3.0, 4.0 |
| BestDuo Abutment | The Abutment is connected with fixtureand it supports prosthesis which restorestooth function. | Mini: Hex 2.1Regular: Hex 2.5 | 3.5, 4.0, 4.8,5.5, 6.5 | Post Height:5.2, 7.2 |
| BestSolidAbutment | The Abutment is connected with fixtureand it supports prosthesis which restorestooth function. | Mini: Hex 2.1Regular: Hex 2.5 | 3.5, 4.0, 4.8,5.5, 6.5 | Post Height:4.2, 4.5, 7.2, 7.5 |
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| BestOcta Abutment | The Abutment is connected with fixtureand it supports prosthesis which restorestooth function. | Mini: Hex 2.1Regular: Hex 2.5 | 3.5, 4.8 | Post Height:2.15 |
|---|---|---|---|---|
| BestAngledAbutment | The Abutment is connected with fixtureand it supports prosthesis which restorestooth function. | Mini: Hex 2.1Regular: Hex 2.5 | 3.5, 4.0, 4.8 | Post Height:7.7 |
| TemporaryAbutment | It is used as the abutment for temporaryprosthetics. | Mini: Hex 2.1Regular: Hex 2.5 | 4.0, 4.8 | Post Height:7.2 |
| Octa PlasticCylinder | It is used as a model for casting and burn-out. | Mini: Hex 2.1Regular: Hex 2.5 | 5.0 | 10.0 |
| Denture Abutment | It is used to connect the denture toimplant. | Mini: Hex 2.1Regular: Hex 2.5 | 3.75, 4.0, 4.8 | Post Height:1.8 |
| Multi-UnitAbutment | It is used to correct the angle betweenimplant and crown and connects them. | Mini: Hex 2.1Regular: Hex 2.5 | 4.8 | Gingival height:1.0, 2.0, 2.5, 3.0,3.5, 4.0, 5.0 |
| Multi-UnitAbutment Screw | It is used to connect and fix the abutmentto the fixture tightly. It makes theabutment act as a crown. | Mini: Hex 2.1Regular: Hex 2.5 | 2.0 | 1.55 |
| Multi-Unit HealingCap | It prevents the contamination of Multi-Unit Abutment | Mini: Hex 2.1Regular: Hex 2.5 | 4.9, 6.2 | $∅4.9:4.2$$∅6.2:4.2$ |
| Multi-UnitTemporaryCylinder | It acts as a pillar of a temporaryprosthetic. | Mini: Hex 2.1Regular: Hex 2.5 | 4.8 | 12 |
| Multi-UnitCylinder Screw | It is used to connect and fix the Multi-UnitCylinder to the abutment tightly | Mini: Hex 2.1Regular: Hex 2.5 | 3.4 | 2.0 |
| Abutment Screw | It is used to connect and fix the abutmentto the fixture tightly. | Mini: Hex 2.1Regular: 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. .
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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 ImplantSystem | Internal Octa ImplantSystem | OSSEOTITE; OSSEOTITE NT; XP;TG OSSEOTITE | JJ Implant System: Genesis Activeand Genesis Normo |
| 510(k) Number | K190837 | K170031 | K063286 | K190552 |
| Device ClassificationName | Implant, Endosseous,Root-form | Implant, Endosseous,Root-form | Implant, Endosseous, Root-form | Implant, Endosseous, Root-form |
| Classification ProductCode | 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 isintended for placement in themaxillary and/or mandibular arches tosupport crowns, bridges, oroverdentures in edentulous orpartially edentulous patients. Forimplant bodies Ø4.1 and greater, theInternal Hex Implant System isintended for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading.Implant bodies with a diameter lessthan Ø4.1 are intended for immediateloading when using a minimum of 4implants with length >8mm. | The Internal Octa Implant System isintended for placement in themaxillary and/or mandibular arches tosupport crowns, bridges, oroverdentures in edentulous orpartially edentulous patients. TheInternal Octa Implant System isintended for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading. | 3i dental implants are intended forsurgical placement in the upper orlowerjaw to provide a means forprosthetic attachment in single toothrestorations and in partially or fullyedentulous spans with multiple singleteeth, or as a terminal or intermediaryabutment for fixed or removablebridgework, and to retainoverdentures. In addition, when aminimum of 4 implants, > 10mm inlength, are placed in the mandible andsplinted in the anterior region,immediate loading is indicated. | JJ Implant System Genesis Activeimplants and Genesis Normoimplants are indicated for placementin the maxillary or mandibular archto provide support for single-unit ormulti-unit restorations forfunctional and estheticrehabilitation. JJ Implant SystemGenesis Active implants andGenesis Normoimplants are indicated forimmediate loading when goodprimary stability is achieved and theocclusalloading is appropriate.JJ Implant System Mini implantsmay be used for denturestabilization using multiple implantsin the anterior mandible and theanterior maxilla, and are indicatedfor immediate loading when goodprimary stability is achieved and theocclusal 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;Endosseous root-form,threaded |
| Body Diameters | 3.25-5.5mm | 4.1, 4.8mm | 3.25, 3.75, 4.0,6.0mm | 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 mmØ5.2: 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 subjectdevice and the Primary predicate. Further reference devices used for technological comparisons of Internal Hex Implant System do not include any component-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 theprimary predicate.2) Connection Type: The primary predicate, K170031 is Octa connection platform type and the subject device is Hex connection platform type. Thisdifference of the connection platform type does not impact substantial equivalence because we have addressed this difference by providing recommendeddescriptive information and non-clinical testing.3) Dimensions: Another major difference between subject and primary predicate is dimensions. To support implants with a length of 7 mm for all diameters,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 itdemonstrated that it is substantially equivalent. |
{7}------------------------------------------------
2) Abutments
| 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) anddimensions. | ||
| Differences | As the primary predicate, K170031 does not include the cover screw, we chose K073116 and K121585 as Reference Device.K073116 was chosen to support the material, indications for Use, and shelf life and K121585 was chosen to support the dimensions.Any difference doesn't impact the substantial equivalence. |
| 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}------------------------------------------------
| 510(k) Number | NA | K142426 | K042971 | |
|---|---|---|---|---|
| Material | Ti-6Al-4V ELI Alloy | Titanium Gr.4 | Ti-6Al-4V ELI Alloy | |
| Design | Image: Design NA | Image: Design K142426 | Image: Design K042971 | |
| Diameters (Ø) | 3.5, 4.0, 4.8, 5.5, 6.5 | 3.4, 3.8, 4.0, 4.1, 4.8, 5.0, 5.5, 6.0, 7.0, 8.0 | 3.5, 4.5, 5.5 | |
| Post Height (mm) | 1.0, 2.0, 3.0, 4.0 | 2.0, 3.0, 4.0, 5.0, 6.0, 6.5, 7.0, 8.0 | Ø3.5: 1.0, 3.0, 5.0Ø4.5: 3.0, 4.0, 5.0 | |
| 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) anddimensions. | |||
| Differences | As the primary predicate, K170031 does not include the Healing Abutments, we chose K142426, K042971 as reference device tosupport the similar indications for use, materials, shelf life, dimensions, and principle of operation. The design of the devices isslightly different but it doesn't impact the substantial equivalence. |
| Subject Device | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|
| Company | EBI Inc. | Neobiotech Co., Ltd. | Neobiotech Co., Ltd. | Implant Logistics, Inc. |
| Device Name | Internal Hex ImplantSystem | IS-III active System | IS-III active System_ S-narrow Type | Implant-One™ System |
| Abutment Name | BestDuo Abutment | IS Cemented Abutment | IS Cemented Abutment | Straight Abutment |
| 510(k) Number | NA | K181138 | K190849 | K173701 |
| Material | Ti-6Al-4V ELI Alloy | Ti-6Al-4V ELI Alloy | Ti-6Al-4V ELI Alloy | Ti-6A1-4V ELI Alloy |
| Design | Image: Design of subject device | Image: Design of reference device | Image: Design of reference device | Image: Design of reference device |
| Diameters (Ø) | 3.5, 4.0, 4.8, 5.5, 6.5 | 4.5, 5.2, 5.7, 6.5 | 3.5, 4.0 | 3.1- 4.5 |
| Post Height (mm) | 5.2, 7.2 | 4.0, 4.5, 5.5, 7.0, 8.0 | Ø3.5: 7.0Ø4.0: 5.5. 7.0 | 8.0 |
| Similarities | The subject and reference devices have similar indications for use, functions, materials, surface treatment, general shape (design)and dimensions. | |||
| Differences | As the primary predicate, K170031 does not include any abutments, we chose K181138, K190849, and K173701 as ReferenceDevice. K181138 was chosen to support the material, indications for Use, principle of operations and large size abutmentdimensions. K190849 was chosen to support the dimensions. K173701 supports the combination of taller height and smallerdiameter abutments such as Ø 3.5x7.2mm. The design of the devices is slightly different but it doesn't impact the substantialequivalence. |
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| Subject Device | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|
| Company | EBI Inc. | Neobiotech Co., Ltd | Neobiotech Co., Ltd. | Implant Logistics, Inc. |
| Device Name | Internal Hex ImplantSystem | CMI Implant IS System | IS-III active System_S-narrow Type | Implant-One™ System |
| Abutment Name | BestSold Abutment | IS Cemented Abutment | IS Cemented Abutment | Straight Abutment |
| 510(k) Number | NA | K113554 | K190849 | K173701 |
| Material | Ti-6Al-4V ELI Alloy | Ti-6Al-4V ELI Alloy | Ti-6Al-4V ELI Alloy | Ti-6Al-4V ELI Alloy |
| Design | Image: BestSold Abutment | Image: CMI Implant IS System | Image: IS-III active System_S-narrow Type | Image: Implant-One System |
| Diameters (Ø) | 3.5, 4.0, 4.8, 5.5, 6.5 | 4.5/5.2/5.7/6.5 | 3.5, 4.0 | 3.1- 4.5 |
| Post Height (mm) | 4.2, 4.5, 7.2, 7.5 | 4.5/5.5/6.0/7.0/8.0 | Ø3.5: 7.0Ø4.0: 5.5, 7.0 | 8.0 |
| Similarities | The subject and reference devices have similar indications for use, functions, materials, surface treatment, general shape (design)and dimensions. | |||
| Differences | As the primary predicate, K170031 does not include any abutments, we chose K113554, K171027 and K173701 as ReferenceDevice. K113554 was chosen to support the material, indications for Use, principle of operations and large size abutmentdimensions. The K190849 was chosen to support 3.5mm diameter of the abutment. K173701 supports the combination of tallerheight and smaller diameter abutments such as Ø 3.5x7.5mm. The design of the devices is slightly different but it doesn't impactthe substantial equivalence. |
| Subject Device | Reference Device | |
|---|---|---|
| Company | EBI Inc. | MEGAGEN IMPLANT CO., LTD |
| Device Name | Internal Hex Implant System | Xpeed AnyRidge Internal Implant System |
| 510(k) Number | NA | K140091 |
| Abutment Name | BestOcta Abutment | Octa Abutment |
| Material | Ti-6Al-4V ELI Alloy | Ti-6Al-4V ELI Alloy |
| Design | Image: Abutment | Image: Abutment |
| Diameters (Ø) | 4.8 | 4.8 |
| Post height (mm) | 2.15 | 2.0, 3.0, 4.0, 5.0 |
| Similarities | The subject and reference devices have similar indications for use, functions, materials, surface treatment, general shape (design)and diameters. | |
| Differences | As the primary predicate, K170031 does not include any abutments, we chose K140091 as Reference Device. K140091 was chosento support the material, indications for Use, and principle of operations and dimensions. The design of the devices is slightlydifferent but it doesn't impact the substantial equivalence. |
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| Subject Device | Reference Device | |
|---|---|---|
| Company | EBI Inc. | EBI Inc. |
| Device Name | Internal Hex Implant System | Ebi External Implant System |
| 510(k) Number | NA | K142426 |
| Material | Ti-6Al-4V ELI Alloy | Ti-6Al-4V ELI Alloy |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameters (Ø) | 3.5, 4.0, 4.8 | 3.5, 4.1, 4.8 |
| Post Height (mm) | 7.7 | 7 |
| Angulations | 15°, 25° | 15°, 25° |
| Similarities | The subject and reference devices have similar indications for use, functions, materials, surface treatment, general shape (design),angulation and dimensions. | |
| Differences | As the primary predicate, K170031 does not include any abutments, we chose K142426 as Reference Device. K142426 was chosento support the material, indications for Use, angulation and principle of operations and dimension. The subject diameters are withinthe range of the reference device diameters. The increase in post height is due to the gingival collar design and it does not impactsubstantial equivalence. |
| Subject Device | Reference Device | |
|---|---|---|
| Company | EBI Inc. | EBI Inc. |
| Device Name | Internal Hex Implant System | EBI External Implant System |
| 510(k) Number | NA | K142426 |
| Material | Ti-6Al-4V ELI Alloy | Ti-6Al-4V ELI Alloy |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameters (Ø) | 4.0, 4.8 | 3.4, 3.5, 4.1, 4.8, 5.1, 5.5 |
| Post Height (mm) | 7.2 | 10.5-11mm |
| Similarities | The subject and reference devices have similar intended use, functions, materials, surface treatment, general shape (design) and diameters. | |
| Differences | As the primary predicate, K170031 does not include any abutments, we chose K142426 Reference Device. The subject device post height is smaller than the reference device post height; however, this difference does not impact substantial equivalence as it does not introduce a new worst case and is greater than the clinically recommended 4mm post height for single unit restorations. |
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| Subject Device | Reference Device | |
|---|---|---|
| Company | EBI Inc. | MEGAGEN IMPLANT CO., LTD |
| Device Name | Internal Hex Implant System | Xpeed AnyRidge Internal Implant System |
| 510(k) Number | NA | K140091 |
| Material | POM | POM |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameters (Ø) | 5.0 | 4.0, 5.0, 6.0 |
| Total Lengths (mm) | 10.0 | 10.0 |
| Similarities | The subject and reference devices have similar indications for use, functions, materials, surface treatment, general shape (design)and diameters. | |
| Differences | As the primary predicate, K170031 does not include any abutments, we chose K140091 as Reference Device. K140091 waschosen to support the material, indications for Use, dimensions and principle of operations. The subject diameter is included in therange of the reference device diameters and it doesn't impact the substantial equivalence. |
| Subject Device | Reference Device | |
| Company | EBI Inc. | EBI Inc. |
| Device Name | Internal Hex Implant System | EBI External Implant System |
| 510(k) Number | NA | K142426 |
| Material | Ti-6Al-4VELI Alloy | Ti-6Al-4VELI Alloy |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameters (Ø) | 3.75, 4.0, 4.8 | 3.4, 4.1, 4.8 |
| Post height (mm) | 1.8 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 |
| Similarities | The subject and reference devices have similar indications for use, functions, materials, surface treatment, general shape (design)and dimensions. | |
| Differences | As the primary predicate, K170031 does not include the abutments, we chose K142426 as reference device to support the similarindications for use, materials, dimensions, and principle of operation. The design of the devices is slightly different but it doesn'timpact the substantial equivalence. |
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| Subject Device | Reference Device | |
|---|---|---|
| Company | EBI Inc. | MIS Implants Technologies Ltd. |
| Device Name | Internal Hex Implant System | MIS V3 Conical Connection Dental Implant System |
| Abutment Name | Multi-Unit Abutment | Multi-Unit Abutment |
| 510(k) Number | NA | K163349 |
| Material | Ti-6Al-4V ELI Alloy | Ti-6Al-4V ELI Alloy |
| Design | Image: Design of subject device | Image: Design of reference device |
| Diameters (Ø) | 4.8 | 4.8 |
| Lengths(mm) | 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0 | 1.0, 2.0, 3.0, 4.0, 5.0 |
| Angulations | 0°, 17°, 30° | 0°, 17°, 30° |
| Similarities | The subject and reference devices have similar indications for use, functions, materials, surface treatment, general shape(design), angulation and dimensions. | |
| Differences | As the primary predicate, K170031 does not include any abutments, we chose K163349 as Reference Device. K163349 waschosen to support the material, indications for Use, angulation and principle of operations and dimension. The design of thedevices is slightly different and the lengths of subject multi-unit abutments are more various but it doesn't impact the substantialequivalence. |
| Subject Device | Reference Devices | |
|---|---|---|
| Company | EBI Inc. | MEGAGEN IMPLANT CO., LTD |
| Device Name | Internal Hex Implant System | Xpeed AnyRidge Internal Implant System |
| 510(k) Number | NA | K140091 |
| Material | Ti-6Al-4VELI Alloy | Ti-6Al-4VELI Alloy |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameters (Ø) | 4.9mm4.9 / 6.9mm | 5.0, 6.0mm |
| Lengths(mm) | 4.2 | 5.4-8.4mm |
| Similarities | The subject and reference device have similar indications for use, functions, materials, surface treatment, generalshape (design) and diameters. | |
| Differences | Minor differences in the dimensions are not expected to impact substantial equivalence because the device is onlyintended during healing for protection and designed for compatibility to the associated abutment. |
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| Subject Device | Reference Device | |
|---|---|---|
| Company | EBI Inc. | InnoBioSurg Co., Ltd. |
| Device Name | Internal Hex Implant System | IBS Implant System II |
| 510(k) Number | NA | K162099 |
| Material | Ti-6Al-4VELI Alloy | Ti-6Al-4VELI Alloy |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameters (Ø) | 4.8 | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 |
| Lengths(mm) | 12 | 12 |
| Similarities | The subject and reference devices have similar indications for use, functions, materials, surface treatment, general shape(design) and dimensions. | |
| Differences | As the primary predicate, K170031 does not include any abutments, we chose K162099 as reference device. The design of thedevices and diameter are still slightly different but it doesn't impact the substantial equivalence. The subject diameter isincluded in the range of the reference device diameters. |
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Similarities
The indications for use, material, surface treatment, application method, sterilization method, general shape design and dimensions are similar between subject device and the reference devices. Further reference devices used for technological comparisons of Internal Hex Implant System do not include any component-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
- Connection Type: The primary predicate, K170031 is Internal Octa Connection System. The . difference of the connection platform type does not impact substantial equivalence because we have addressed this difference by providing recommended descriptive information and non-clinical testing.
- Dimensions: Another major difference between subject and reference devices is dimensions. To . support implants with a length of 7 mm for all diameters, implants with a diameter of 3.25 and5.5mm at proposed lengths and implants with lengths of 15.7-18mm for diameter 3.25-4.8mm, we chose K063286 and it demonstrated that it is substantially equivalent.
- . There is new abutment system for the subject device compared to the primary predicate, K170031. There are slight differences of the dimensions and designs between the subject abutments and reference device; however, since we identified the references devices to support the discrepancy, the difference doesn't impact the substantial equivalence.
Accordingly, we can claim the substantially equivalence of the Internal Hex Implant System to reference devices.
Non-Clinical Data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- . Fatigue Test under worst case scenario according to ISO 14801:2016
- Cytotoxicity Test according to ISO 10993-5 for abutments made of Ti-6AI-4V ELI Alloy
- . End User Sterilization Validation according to ISO 17665-1
Below tests were performed for reference devices and leveraged for the subject device:
- Biocompatibility Test according to ISO 10993-1 for fixtures referenced in K170031
- Accelerated Aging Test (Shelf Life Test) according to ASTM F1980-07 referenced in K073116 ● and K170031
- . Bacterial Endotoxin Test according to USP <161> referenced in K170031
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the reference device.
Biocompatibility Test was conducted on the reference device, K170031 and it demonstrates that the subject fixtures are biocompatible and substantial equivalence with the reference device. The fixture's surface is treated with SLA (Sandblast, Large grit Acid etched). The surface treatment information from K170031 can be leveraged for the subject device because it is similar.
Cytotoxicity Test was conducted for subject abutments made of Ti-6AI-4V ELI Alloy, and it demonstrates that the subject abutments are biocompatible and substantial equivalence with the reference device. Pyrogenicity information as recommended by the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
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Fatigue Testing for subject fixture and multi-unit angled abutment was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-Form Endosseous Dental Implants and Endosseous dental Abutment" and ISO 14801:2016 Dentistry - Fatigue test for endoseous dental implants under the worst-case scenario to ensure that the subject device is strong enough for its intended use.
Sterilization Validation performed on our own reference device. K142426 according to ISO 11137-1.2.3 was leveraged for the subject device. The sterilization methods and results are identical between the subject and reference device and it demonstrated the substantial equivalence with the reference device.
End user sterilization validation test according to ISO 17665-1:2006, -2:2009 and ANSI/AAMI ST79 was performed for subject abutments.
The shelf life test performed on our own reference device. K073116 and K170031 was leveraged for the subject device and it demonstrated the substantial equivalence with the reference device.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the reference device.
Conclusion:
The Internal Hex Implant System, subject device of this submission, constitutes a substantially equivalent medical device. This system has the similar intended use and fundamental scientific technology as its reference devices. Therefore, the subject devices are substantially equivalence to the reference devices.
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.