The J2A SLA Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The J2A SLA Dental Implant System is for single and two stage surgical procedures. The system is intended for delayed loading.

Device Description

The J2A SLA Dental Implant System is internal hexagon type dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the system has been treated with SLA (sandblasted, Large- grit, Acid-etched).

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
SEM surface analysis	Not explicitly stated, but implies meeting surface characteristics for SLA treated implants	Conducted
EDS Surface chemistry analysis	Not explicitly stated, but implies meeting chemical composition for SLA treated implants	Conducted
Cytotoxicity test (ISO 10993-5)	Non-cytotoxic	Conducted (implies non-cytotoxic)
Skin sensitization test (ISO 10993-10)	Non-sensitizing	Conducted (implies non-sensitizing)
Intracutaneous reactivity test (ISO 10993-10)	Non-reactive	Conducted (implies non-reactive)
Sterilization validation test (ISO 11137-1 & -2)	Sterilized according to standards	Conducted (implies meeting sterilization standards)
Shelf life validation test: visual inspection	Pass visual inspection (no degradation)	Conducted (implies pass visual inspection)
Shelf life validation test: label	Maintain label integrity	Conducted (implies label integrity maintained)
Shelf life validation test: seal inspections (ASTM F88)	Maintain seal integrity	Conducted (implies seal integrity maintained)
Shelf life validation test: dye penetration (ISO 11607-1 & -2)	No dye penetration, maintaining sterile barrier integrity	Conducted (implies no dye penetration)
Shelf life validation test: microbial challenge (ISO 11737-2)	Maintain sterility	Conducted (implies sterility maintained)
Endotoxin testing (USP <85>)	Below 0.5 EU/mL	Conducted (referenced USP 39 <85> for the 0.5 EU/mL limit)

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

The document does not explicitly state the specific sample sizes for each non-clinical test conducted (e.g., number of implants tested for SEM, cytotoxicity, etc.). The study is a retrospective comparison to a predicate device (J2A Dental Implant System, J2C Dental Implant System, K150060) and aims to demonstrate substantial equivalence to this already marketed device. The data provenance would be from internal testing conducted by KJ Meditech Co., Ltd.

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

The document does not describe an expert-based ground truth establishment for the non-clinical tests. These tests (e.g., SEM analysis, cytotoxicity, sterilization validation) inherently have objective, measurable endpoints determined by established scientific methods and standards, rather than expert interpretation of images or clinical outcomes.

4. Adjudication method for the test set

Not applicable, as the tests are objective and do not involve human interpretation or adjudication for ground truth.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device (dental implant). This submission focuses on the safety and performance of the physical implant itself, not on an AI-driven diagnostic or assistive tool for human readers.

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

No, a standalone (algorithm only) performance study was not performed, nor is it applicable. This device is a physical dental implant, not a software algorithm.

7. The type of ground truth used

The ground truth for the non-clinical tests is established by objective measurements and adherence to international standards (e.g., ISO, ASTM, USP). For instance:

Pathology/Histology (indirectly): Cytotoxicity and intracutaneous reactivity tests assess biological responses at a cellular and tissue level, often involving microscopic examination by trained professionals, but the 'truth' is defined by the biological reaction severity against established criteria.
Physical/Chemical Standards: SEM, EDS, and physical integrity tests (seal, dye penetration) are based on direct physical and chemical measurements against defined specifications.
Microbiological Standards: Sterilization and microbial challenge tests are based on established microbiological methods to confirm the absence or reduction of microorganisms.
Analytical Standards: Endotoxin testing follows a defined analytical method to quantify endotoxin levels against a specified limit.

8. The sample size for the training set

Not applicable. This submission is for a physical medical device (dental implant), not a machine learning or AI-based system that requires a "training set."

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

Not applicable. As a physical medical device, there is no "training set" or need to establish ground truth in the context of machine learning.

Summary

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

November 9, 2017

KJ Meditech Co., Ltd. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, California 92620

Re: K161923

Trade/Device Name: J2A SLA Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 7, 2017 Received: October 10, 2017

Dear Priscilla Chung:

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.

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

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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,

Mary S. Runner -S

for

Tina Kiang, Ph.D. Acting 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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Indications for Use

510(k) Number (if known) K161923

Device Name J2A SLA Dental Implant System

Indications for Use (Describe)

The J2A SLA Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The J2A SLA Dental Implant System is for single and two stage surgical procedures. These systems are intended for delayed loading.

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 (K161923)

This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 11/09/2017

1. Submitter

	Submitter
Name	KJ Meditech Co., Ltd.
Address	21, Cheomdan Venture-ro40 Beon-gil, Buk-guGwangju, Jeonranamdo, Republic of Korea 500-470
Phone	+82-62-972-5476
Fax	+82-62-973-2809
Contact	Huykki Moon, CEO

2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine CA 92620 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

Trade Name: J2A SLA Dental Implant System ●
Common Name: Dental Implant System
Classification Name: Endosseous Dental Implant System ●
Product Code: DZE, NHA ●
. Classification regulation: 21CFR872.3640

4. Predicate Device:

J2A Dental Implant System, J2C Dental Implant System (K150060) by KJ Meditech Co., Ltd.

5. Description:

The J2A SLA Dental Implant System is internal hexagon type dental implant systems made

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of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the system has been treated with SLA (sandblasted, Large- grit, Acid-etched). The size information is as below.

· 3.75mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
· 4.00mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
· 4.30mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
· 4.50mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
5.00mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L) · 5.50mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
· 6.00mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)

6. Indication for use:

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7. Basis for Substantial Equivalence

Item	Subject Device	Predicate Device	Appearance	Image: Dental implants with SLA Treatment	Image: Dental implants with RBM Treatment
510(K) Number	-	K150060	Endosseous ImplantMaterial	Ti 6A1 4V ELI, ASTM F136	Ti 6Al 4V ELI, ASTM F136
Device Name	J2A SLA Dental Implant	J2A Dental Implant System,J2C Dental Implant System	Surface Treatment	SLA Treatment	RBM Treatment
Manufacturer	KJ Meditech Co., Ltd.	KJ Meditech Co., Ltd.	Sterilization Method	Gamma	Gamma
Indications for Use	The J2A SLA Dental ImplantSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single or multiple-unit restorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate abutmentsupport for fixed bridgework.The J2A SLA Dental Implantis for single and two stagesurgical procedures. Thesystem is intended fordelayed loading.	The J2A Dental ImplantSystem, J2C Dental ImplantSystem are indicated for usein partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate abutmentsupport for fixedbridgework. The J2A DentalImplant System, J2C DentalImplant System are forsingle and two stage surgicalprocedures. These systemsare intended for delayedloading.	Implant Diameters	3.75mm, 4.0mm, 4.3mm,4.5mm, 5.0 mm, 5.5mm,6.0mm	3.75mm, 4.0mm, 4.3mm,4.5mm, 5.0 mm, 5.5mm,6.0mm
Design	• Implant Type: Bone LevelImplant• Connection Type: InternalHexagon• Neck Design: Straightwalled neck• Body Design: Tapereddesign	• Implant Type: Bone LevelImplant• Connection Type: InternalHexagon• Neck Design: Straightwalled neck with micro-thread• Body Design: Tapereddesign	Implant Lengths	7mm – 15.0 mm	7mm – 15.0 mm

The J2A SLA Dental Implant System has the same intended use and technical characteristics as the unmodified device. They are exactly identical except the surface treatment.

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8. Non-Clinical Testing

Risk analysis was conducted according to ISO14971 to evaluate the effect of the modification which is surface treatment change from RBM to SLA for fixtures. Through risk analysis and the following validation/verification tests, we conclude that the J2ASLA Dental Implant System is substantially equivalent to the unmodified device.

The following tests were carried out:

SEM surface analysis
EDS Surface chemistry analysis
Cytotoxicity test (10993-5)
Skin sensitization test (10993-10)
Intracutaneous reactivity test (10993-10)
Sterilization validation test (ISO 11137-1 & ISO 11137-2)
Shelf life validation test: visual inspection, label, seal inspections (ASTMF88), dye penetration (ISO 11607-1 & 11607-2) and microbial challenge (ISO11737-2). Fatigue testing was not conducted because the subject device does not have an angled abutment.

The USP <85> test method will be used to evaluate pyrogen limit specifications for the subject device. The endotoxin testing will be conducted on every batch for the subject device and the testing limit will be below 0.5 EU/mL. We referenced the USP 39 <85> to device on the endotoxin limit which is 0.5 EU/mL.

9. Conclusion

The subject devices and the predicate device have the same intended use and have the same technological characteristics.

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Overall, the J2A SLA Dental Implant system has the following similarities to the predicate device:

- have the same intended use,
- use the same operating principle,
- incorporate the same design,
- incorporate the same material and the sterilization method.

Based on the similarities, we conclude that the J2A SLA Dental Implant system is substantially equivalent to the predicate device.

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.