EBI Dental Implant System is intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

Device Description

An endosseous dental implant is a device made of a material such as Pure Titanium Grade 4 and Titanium alloy (Ti-6A1-4V ELI). EBI Implant system has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placement. EBI Implant systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The EBI External Implant System has an external connection.

The surface of the system has been treated with RBM (Resorbable Blasted media).

The Fixture diameters are 3.25, 3.3, 3.75, 4, 4.1, 4.8, 5, 5.5, 6, 6.5, 7mm and lengths are 7, 8, 8.1, 8.5, 9, 9.6, 10, 11, 11.5, 12, 12.6, 13, 14, 14.6, 15mm in this system.

The contained various abutments and accessories in the system are cover screw, healing abutment, cemented abutment, temporary abutment, healing cap, impression coping, analog, fixture mount, Ti-screw, angled abutment, impression guide pin, gold UCLA abutment and locator.

Fixtures and abutments are packaged separately. The Fixtures are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use.

AI/ML Overview

The EBI External Implant System is a dental implant system. The provided document is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than proving specific acceptance criteria with detailed studies in the manner typically seen for novel AI/software devices. Therefore, the information typically requested for AI/software-based devices regarding acceptance criteria, ground truth, sample sizes, and expert adjudication for performance studies is not directly applicable or available in this document.

However, based on the provided text, we can glean information about the performance testing conducted and how it demonstrates "safety and effectiveness" in the context of a dental implant.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or F1-score, as would be expected for a diagnostic or AI-driven decision support system. Instead, for a dental implant, performance is assessed through bench testing demonstrating structural integrity and compliance with recognized standards.

Acceptance Criteria (Implied)	Reported Device Performance
Fatigue Resistance (to ensure durability under physiological loads)	Fatigue Testing was performed in accordance with ISO 14801:2007
Biocompatibility (materials used are safe for implantation)	Fabricated from CP Titanium (Grade 4) conforming to ASTM F67 and Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136
Sterility (implants are sterile)	Fixtures are supplied sterile; abutments and accessories are provided non-sterile but should be sterilized before use; Gamma Sterilization: Yes
Shelf Life (maintaining integrity over time)	5 years

2. Sample size used for the test set and the data provenance

The document doesn't provide specific sample sizes for the fatigue testing in terms of the number of tested devices. It only states that "Fatigue Testing was performed in accordance with ISO 14801:2007." ISO 14801 specifies test methods for dental implants, which would inherently include a defined number of samples to ensure statistical validity, but this detail is not explicitly stated in the 510(k) summary.

Data Provenance: The testing was conducted by EBI Inc., a South Korean company.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable in the context of this device and testing. The "ground truth" for a dental implant's mechanical performance is defined by adherence to engineering standards and material specifications, not expert consensus on an image or diagnosis.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in clinical performance studies, typically for diagnostic devices. Mechanical bench testing of an implant does not involve such human-based adjudication.

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 is a medical device (dental implant), not an AI or software-assisted diagnostic system. Therefore, MRMC studies examining human reader performance with or without AI are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. There is no algorithm. The device is a physical dental implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance of the EBI External Implant System is based on established engineering and material standards, specifically:

ISO 14801:2007 for fatigue testing of dental implants.
ASTM F67 for unalloyed titanium (CP Titanium Grade 4) used in dental implants.
ASTM F136 for wrought titanium-6aluminum-4vanadium alloy (Ti-6Al-4V ELI) for surgical implant applications.
General device safety and effectiveness principles outlined in FDA's Class II special controls guidance document for root-form endosseous dental implants and abutments.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a learning algorithm or AI/ML device.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. Above the profiles are three curved lines, resembling flowing hair or abstract shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 27, 2015

Ebi Inc c/o Ms. April Lee Consultant WithUS Consulting 2531 Pepperdale Drive Rowland Heights, CA 91748

Re: K142426

Trade/Device Name: Ebi External Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: February 23, 2015 Received: February 27, 2015

Dear Ms. 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. 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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Page 2 - Ms. April Lee

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

K142426 510(K) Number (if known):

Device Name: EBI Dental Implant System

Indication for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter

(Part 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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Image /page/3/Picture/1 description: The image shows the logo for EBI Implant. The logo has the letters "EBI" in a dark teal color, stacked on top of the word "IMPLANT" which is in a lighter teal color. To the right of the letters "EB" is a small orange circle, which appears to be the dot above the letter "i".

124, Uisong-gil, Amnyang-myeon, Gyeongsan-si, Gyeongsangbuk-do, South Korea, 712-825 Tel. 82- 53-817-7767 / Fax. 82-53-817-7768

510(k) Summary

Submitter

EBI Inc. Mi Sook Kim 124, Uisong-gil, Amnyang-myeon, Gyeongsan-si Gyeongsangbuk-do 712-825 South Korea Email: dei@ebiimplant.com Tel. +82-53-817-7767 Fax. +82-53-817-7768

Device Information

Official Correspondent

WithUS Consulting April Lee 2531 Pepperdale Drive, Rowland Heights, CA 91748 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Trade Name: EBI External Implant System ●
Common Name: Dental Implant System
Classification Name: implant, endosseous, root-form
Product Code: DZE, NHA
Panel: Dental
Regulation Number: 872.3640 ●
Device Class: Class II
Date prepared: 3/23/2015

General Description

The surface of the system has been treated with RBM (Resorbable Blasted media).

The Fixture diameters are 3.25, 3.3, 3.75, 4, 4.1, 4.8, 5, 5.5, 6, 6.5, 7mm and lengths are 7, 8, 8.1, 8.5, 9, 9.6, 10, 11, 11.5, 12, 12.6, 13, 14, 14.6, 15mm in this system.

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Image /page/4/Picture/0 description: The image shows the logo for EBI Implant. The logo consists of the letters "EBI" in a bold, teal font, stacked on top of the word "IMPLANT" in a smaller, teal font. There is a small, orange circle to the right of the "I" in "EBI."

124, Uisong-gil, Amnyang-myeon, Gyeongsan-si, Gye angbuk-do, South Korea, 712-825 Tel. 82- 53-817-7767 / Fax. 82-53-817-

Indication for Use

Materials:

The devices are fabricated from CP Titanium (Grade 4) that conforms to ASTM F67 for Dental Implant and Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 for Abutments.

Performance Data (Bench Testing):

Fatigue Testing was performed in accordance with ISO 14801:2007 under the worst case scenario.

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

K073116, EBI Internal Implant System manufactured by EBI, Inc.
K111216, OSSEOTITE2 Dental Implants manufactured by BIOMET 31, Inc.
K063286, OSSEOTITE; OSSEOTITE NT; XP; TG; OSSEOTITE manufactured by Implant . innovations inc.
K052369, Exfeel Implant System manufactured by Megagen Implant Co., Ltd.

Comparison to Predicate Devices:

	Subject Device	Predicate Device	Predicate Device	Predicate Device	Predicate Device
Company	EBI Inc.	EBI, Inc	BIOMET 31, INC.	IMPLANTINNOVATIONS,INC.	MEGAGENIMPLANT CO.,LTD.
Device Name	EBI ExternalImplant System	EBI InternalImplant System	OSSEOTITE 2DENTALIMPLANTS	OSSEOTITE;OSSEOTITE NT;XP; TGOSSEOTITE	EXFEELIMPLANTSYSTEM

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Image /page/5/Picture/0 description: The image shows the logo for EBI Implant. The logo consists of the letters "EBI" in a bold, teal-colored font. Below the letters, the word "IMPLANT" is written in a smaller, teal-colored font. To the right of the "I" in "EBI", there is a small, orange circle.

EBI Inc.

124, Uisong-gil, Amnyang-myeon, Gyeongsan-si, Gyeongsangbuk-do, South Korea, 712-825
17-7767

510(k)Number	N/A	K073116	K111216	K063286	K052369
DeviceClassificationName	Same as predicate	Implant,Endosseous,Root-Form	Implant,Endosseous, Root-Form	Implant,Endosseous, Root-Form	Implant,Endosseous,Root-Form	ImplantDiameters	3.25,3.3,3.754,4.1,4.8,5,5.56,6.5,7mm	3.3-4 mm	3.25,3.75,4,5,6mm	3.25,3.75,4,5,6mm	3.3,3.75,4,4.5,5,5.5mm
ClassificationProduct Code	DZE, NHA	DZE, NHA	DZE	DZE	DZE	ImplantLengths	7,8,8.1,8.5,9,9.6,10,11,11.5,12,12.6,13,14,14.6,15mm	6-15 mm	6.5,8.5,1011.5,13,15mm	7,8.5,10,11.5,13,15mm	7,8.5,10,11.5,13,15mm
RegulationNumber	872.3640	872.3640	872.3640	872.3640	872.3640	Components	Implants andvarious abutments	Implants andvariousabutments	Implants andvarious abutments	Implants andvarious abutments	Implants andvariousabutments
Intended Use	Intended forimmediate,delayed, orconventionalplacement in themaxillary and/ormandibular archesto support crowns,bridges, oroverdentures inedentulous orpartiallyedentulous patients	intended forimmediate,delayed, orconventionalplacement in themaxillary and/ormandibulararches tosupport crowns,bridges, oroverdentures inedentulous orpartiallyedentulouspatients	Intended forsurgical placementin the upper orlower jaw toprovide a meansfor prostheticattachment insingle toothutilizing delayedor immediateloading or with aterminal orintermediaryabutment for fixedor removablebridgework, andto retainoverdentures	Intended forsurgical placementin the upper orlower jaw toprovide a meansfor prostheticattachment insingle toothutilizing delayedor immediateloading or with aterminal orintermediaryabutment for fixedor removablebridgework, andto retainoverdentures	Intended to bplaced in theupper or lowerjaw to supportprostheticdevices, such asartificial teeth,and to restore apatient'schewing function	ConnectionType	External	Internal	External	External	External
Material	CommerciallyPure Titanium&Titanium Alloy	CommerciallyPure Titanium&TitaniumAlloy	CommerciallyPure Titanium&Titanium Alloy	CommerciallyPure Titanium	CommerciallyPure Titanium	SurfaceTreatment	Resorbable BlastMedia (RBM)	Resorbable BlastMedia (RBM)	Full OSSEOTITE	Full OSSEOTITE	Resorbable BlastMedia (RBM)
Design	Image: Implant design	Image: Implant design	Image: Implant design	Image: Implant design	Image: Implant design	GammaSterilization	Yes	Yes	Yes	Yes	Yes
Shelf Life	5 years	5 years	5 years	5 years	5 years
Angulationof AngledAbutment	15°, 25°	15°, 25°	15°	15°	15°, 25°

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Image /page/6/Picture/0 description: The image shows the logo for EBI Implant. The logo consists of the letters "EBI" in a bold, teal font. Below the letters, the word "IMPLANT" is written in a smaller, teal font. The letter "i" in "EBI" has an orange circle above it, replacing the dot.

124, Uisong-gil, Amnyang-myeon, Gyeongsan-si, Gyeongsangbuk-do, South Korea, 712-825 Tel. 82- 53-817-7767 / Fax. 82-53-817

Substantial Equivalence Discussion

The EBI External implant System has a substantially equivalent intended use as the identified predicates. The subject device is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutment, and they are all constructed of titanium.

The subject and predicate devices are similar in indications, design, technology, functions, dimensions and materials.

The only differences between the subject device and the predicate devices are slight differences in fixture designs and diameters.

Any differences in technology characteristics are accompanied by information that demonstrated the device is safe and effective as the predicate and do not raise different questions of safety and effectiveness than the predicate.

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Image /page/7/Picture/0 description: The image shows the logo for EBI Implant. The logo consists of the letters "EBI" in a bold, sans-serif font, stacked above the word "IMPLANT" in a smaller, sans-serif font. The letters "EB" are in a dark teal color, while the "i" has a small orange circle above it, replacing the dot. The word "IMPLANT" is in the same dark teal color as the "EB".

EBI Inc 124, Uisong-gil, Amnyang-myeon, Gyeongsan-si, Gyeongsangbuk-do, South Korea, 712-825 Tel. 82- 53-817-7767 / Fax. 82-53-817-7768

Conclusion

The EBI External Implant System, subject device of this submission, constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. The risks of using the device as recommended pose no greater risks than any other implant systems. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, EBI External Implant System and its predicates are substantially equivalent.

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.