Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical and biological properties.

Therapeutic

Yes
The device is described as "intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients," which directly addresses a health condition (tooth loss) and provides a treatment to restore function (mastication).

Diagnostic

No

The device is an endosseous dental implant system, intended for the placement in the mouth to support crowns, bridges, or overdentures. It is a treatment device, not designed for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is composed of "Pure Titanium Grade 4" and includes various physical components like implant bodies and abutments. This indicates it is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for placement in the body (maxillary and/or mandibular arches) to support dental restorations. This is a surgical and prosthetic application, not a diagnostic test performed on samples outside the body.
Device Description: The description details a physical implant system made of titanium, designed for surgical implantation and supporting dental prosthetics. This aligns with a medical device, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
Performance Studies: The performance studies focus on mechanical properties (fatigue), biocompatibility, and sterilization validation, which are typical for implantable medical devices, not IVDs.

In summary, the Internal Hex Implant System is a medical device intended for surgical implantation and prosthetic support, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended 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.

Product codes

DZE, NHA

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).

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillary and/or mandibular arches

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K170031

Reference Device(s)

K042971, K063286, K073116, K113554, K121585, K140091, K142426, K162099, K163349, K181138, K190849, K173701, K190552

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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 Platform Type | Body Diameter |-------------------------|-------- | BLT II
OS
Implant | Hex 2.1 13.2,13.7,14.2,14.7,15.2,15.7 | | Hex 2.1 12.7,13.0.13.2.13.7,14.2.14.7,15.0. | | Hex 2.5 13.2,13.7,14.2,14.7,15.2,15.7 | | Hex 2.5 12.7,13.0.13.2.13.7,14.2.14.7,15.0. | | Hex 2.5 13.2,13.7,14.2,14.7,15.2,15.7 | | Hex 2.5 12.7,13.0.13.2.13.7,14.2.14.7,15.0. | | Hex 2.5 13.2,13.7,14.2,14.7,15.2,15.7 | | Hex 2.5 12.7,13.0.13.2.13.7,14.2.14.7,15.0. | | Hex 2.5 13.2,13.7,14.2,14.7,15.2,15.7 | | Hex 2.5 12.7,13.0.13.2.13.7,14.2.14.7,15.0. | | Hex 2.5 | | Hex 2.5 | Connection
(Ø) | Length (mm) |
---------------------|-------------------|--------------------------------------------------------------------------------------------------------------------------|
| 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,
|
| 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.
15.2.15.7,18.0 |
| 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,
|
| 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.
15.2.15.7,18.0 |
| 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,
|
| 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.
15.2.15.7,18.0 |
| 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,
|
| 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.
15.2.15.7,18.0 |
| 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,
|
| 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.
15.2.15.7,18.0 |
| 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 |
| 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
Type and size | Diameter
(Ø) | Length (mm) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|----------------------------|----------------------------------------|
| Cover Screw | It is used for protecting inner hole and
connecting part with exposed upper part
of structure during the healing period after
inserting dental implant fixture. | Mini: Hex 2.1
Regular: Hex 2.5 | 3.0, 3.2, 3.6 | Gingival height:
0.4, 1.25, 2.25 |
| Healing Abutment | It is used to formation appropriate
gingival shape during the soft tissue
healing period combined with implant. | Mini: Hex 2.1
Regular: 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 fixture
and it supports prosthesis which restores
tooth function. | Mini: Hex 2.1
Regular: Hex 2.5 | 3.5, 4.0, 4.8,
5.5, 6.5 | Post Height:
5.2, 7.2 |
| BestSolid
Abutment | The Abutment is connected with fixture
and it supports prosthesis which restores
tooth function. | Mini: Hex 2.1
Regular: Hex 2.5 | 3.5, 4.0, 4.8,
5.5, 6.5 | Post Height:
4.2, 4.5, 7.2, 7.5 |

5

| BestOcta Abutment | The Abutment is connected with fixture
and it supports prosthesis which restores
tooth function. | Mini: Hex 2.1
Regular: Hex 2.5 | 3.5, 4.8 | Post Height:
2.15 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------|----------------|----------------------------------------------------------|
| BestAngled
Abutment | The Abutment is connected with fixture
and it supports prosthesis which restores
tooth function. | Mini: Hex 2.1
Regular: Hex 2.5 | 3.5, 4.0, 4.8 | Post Height:
7.7 |
| Temporary
Abutment | It is used as the abutment for temporary
prosthetics. | Mini: Hex 2.1
Regular: Hex 2.5 | 4.0, 4.8 | Post Height:
7.2 |
| Octa Plastic
Cylinder | It is used as a model for casting and burn-
out. | Mini: Hex 2.1
Regular: Hex 2.5 | 5.0 | 10.0 |
| Denture Abutment | It is used to connect the denture to
implant. | Mini: Hex 2.1
Regular: Hex 2.5 | 3.75, 4.0, 4.8 | Post Height:
1.8 |
| Multi-Unit
Abutment | It is used to correct the angle between
implant and crown and connects them. | Mini: Hex 2.1
Regular: Hex 2.5 | 4.8 | Gingival height:
1.0, 2.0, 2.5, 3.0,
3.5, 4.0, 5.0 |
| Multi-Unit
Abutment Screw | It is used to connect and fix the abutment
to the fixture tightly. It makes the
abutment act as a crown. | Mini: Hex 2.1
Regular: Hex 2.5 | 2.0 | 1.55 |
| Multi-Unit Healing
Cap | It prevents the contamination of Multi-
Unit Abutment | Mini: Hex 2.1
Regular: Hex 2.5 | 4.9, 6.2 | $∅4.9:4.2$
$∅6.2:4.2$ |
| Multi-Unit
Temporary
Cylinder | It acts as a pillar of a temporary
prosthetic. | Mini: Hex 2.1
Regular: Hex 2.5 | 4.8 | 12 |
| Multi-Unit
Cylinder Screw | It is used to connect and fix the Multi-Unit
Cylinder to the abutment tightly | Mini: Hex 2.1
Regular: Hex 2.5 | 3.4 | 2.0 |
| Abutment Screw | It is used to connect and fix the abutment
to the fixture tightly. | Mini: Hex 2.1
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
System	Internal Octa Implant
System	OSSEOTITE; OSSEOTITE NT; XP;
TG OSSEOTITE	JJ Implant System: Genesis Active
and Genesis Normo
510(k) Number	K190837	K170031	K063286	K190552
Device Classification
Name	Implant, Endosseous,
Root-form	Implant, Endosseous,
Root-form	Implant, Endosseous, Root-form	Implant, Endosseous, Root-form
Classification Product
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
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.	The Internal Octa 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. The
Internal Octa Implant System is
intended for immediate loading when
good primary stability is achieved and
with appropriate occlusal loading.	3i dental implants are intended for
surgical placement in the upper or
lowerjaw to provide a means for
prosthetic attachment in single tooth
restorations and in partially or fully
edentulous spans with multiple single
teeth, or as a terminal or intermediary
abutment for fixed or removable
bridgework, and to retain
overdentures. In addition, when a
minimum of 4 implants, > 10mm in
length, are placed in the mandible and
splinted in the anterior region,
immediate loading is indicated.	JJ Implant System Genesis Active
implants and Genesis Normo
implants are indicated for placement
in the maxillary or mandibular arch
to provide support for single-unit or
multi-unit restorations for
functional and esthetic
rehabilitation. JJ Implant System
Genesis Active implants and
Genesis Normo
implants are indicated for
immediate loading when good
primary stability is achieved and the
occlusal
loading is appropriate.
JJ Implant System Mini implants
may be used for denture
stabilization using multiple implants
in the anterior mandible and the
anterior maxilla, and are indicated
for immediate loading when good
primary stability is achieved and the
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;
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 mm
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
device 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 the
primary predicate.

Connection Type: The primary predicate, K170031 is Octa connection platform type and the subject device is Hex connection platform type. This
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 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 it
demonstrated that it is substantially equivalent. | | | |

7

K190837

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) and
dimensions.
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

K190837

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, 5.0
Ø4.5: 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) and
dimensions.
Differences	As the primary predicate, K170031 does not include the Healing Abutments, we chose K142426, K042971 as reference device to
support the similar indications for use, materials, shelf life, dimensions, and principle of operation. The design of the devices is
slightly 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 Implant
System	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: 7.0
Ø4.0: 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 Reference
Device. K181138 was chosen to support the material, indications for Use, principle of operations and large size abutment
dimensions. K190849 was chosen to support the dimensions. K173701 supports the combination of taller height and smaller
diameter abutments such as Ø 3.5x7.2mm. The design of the devices is slightly different but it doesn't impact the substantial
equivalence.

9

	Subject Device	Reference Device	Reference Device	Reference Device
Company	EBI Inc.	Neobiotech Co., Ltd	Neobiotech Co., Ltd.	Implant Logistics, Inc.
Device Name	Internal Hex Implant
System	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: 7.0
Ø4.0: 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 Reference
Device. K113554 was chosen to support the material, indications for Use, principle of operations and large size abutment
dimensions. The K190849 was chosen to support 3.5mm diameter of the abutment. K173701 supports the combination of taller
height and smaller diameter abutments such as Ø 3.5x7.5mm. The design of the devices is slightly different but it doesn't impact
the 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 chosen
to support the material, indications for Use, and principle of operations and dimensions. The design of the devices is slightly
different but it doesn't impact the substantial equivalence.

10

	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 chosen
to support the material, indications for Use, angulation and principle of operations and dimension. The subject diameters are within
the range of the reference device diameters. The increase in post height is due to the gingival collar design and it does not impact
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-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.

11

	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 was
chosen to support the material, indications for Use, dimensions and principle of operations. The subject diameter is included in the
range 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-4V
ELI Alloy	Ti-6Al-4V
ELI 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 similar
indications for use, materials, dimensions, and principle of operation. The design of the devices is slightly different but it doesn't
impact the substantial equivalence.

12

	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 was
chosen to support the material, indications for Use, angulation and principle of operations and dimension. The design of the
devices is slightly different and the lengths of subject multi-unit abutments are more various but it doesn't impact the substantial
equivalence.

	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-4V
ELI Alloy	Ti-6Al-4V
ELI Alloy
Design	Image: Subject Device Design	Image: Reference Device Design
Diameters (Ø)	4.9mm
4.9 / 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, general
shape (design) and diameters.
Differences	Minor differences in the dimensions are not expected to impact substantial equivalence because the device is only
intended during healing for protection and designed for compatibility to the associated abutment.

13

	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-4V
ELI Alloy	Ti-6Al-4V
ELI 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 the
devices and diameter are still slightly different but it doesn't impact the substantial equivalence. The subject diameter is
included in the range of the reference device diameters.

14

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 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.

15

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.