The I2A Dental Implant System and I2C Dental Implant System are 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 12A Dental Implant System and J2C Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

Device Description

The J2A Dental Implant System and J2C Dental Implant System are 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 systems are 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 these systems have been treated with R.B.M (Resorbable Blast Media).

AI/ML Overview

The provided document is a 510(k) summary for the J2A Dental Implant System and J2C Dental Implant System. It presents a comparison to predicate devices to establish substantial equivalence, rather than a study proving performance against acceptance criteria in the context of an AI/software as a medical device (SaMD).

Therefore, I cannot extract information related to:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance.
Number and qualifications of experts for ground truth.
Adjudication method.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
Standalone algorithm performance.
Type of ground truth for test set.
Sample size for training set.
Ground truth establishment for training set.

The document discusses non-clinical testing which was conducted to demonstrate substantial equivalence, but not a study of the device's performance against specific clinical acceptance criteria in the way an AI/SaMD would be evaluated. It states:

Non-Clinical Testing:

Risk analysis was conducted according to ISO14971 to demonstrate that modifications to the company's own predicate, Hero II Dental Implant System (K121047), are substantially equivalent.
Modifications evaluated include:
- Fixture thread design change.
- Fixture size addition.
- Coating area expansion for one-piece type abutments.
- Abutment size addition.
Additional predicate devices of similar design and dimensions were identified to determine substantial equivalence.
Based on the risk analysis, the shelf-life, sterilization, biocompatibility, and performance testing of the predicate, Hero II Dental Implant System (K121047), is applicable to the subject device.

Conclusion on Substantial Equivalence:
The document concludes that the J2A Dental Implant system and the J2C Dental Implant system are substantially equivalent to the predicate devices because they:

Have the same intended use.
Use the same operating principle.
Incorporate the same basic design.
Incorporate the same material and surface treatment.

This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance metrics from a clinical study against specific acceptance criteria.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around the perimeter. At the center of the seal is a stylized representation of a human figure, composed of three overlapping profiles facing to the right. The seal is rendered in black and white.

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

April 2, 2015

KJ Meditech Co., Ltd. C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 East Chapman Avenue, Suite 110 Fullerton, California 92831

Re: K150060

Trade/Device Name: J2A Dental Implant System, J2C Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 02, 2015 Received: March 06, 2015

Dear Ms. 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.

{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 (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K150060

Device Name J2A Dental Implant System, J2C Dental Implant System

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

510(k) Summary (K150060)

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

Date: 04/02/2015

1. Submitter

	Submitter
Name	KJ Meditech Co., Ltd.
Address	959-21 Daechon-dong, Buk-gu,Gwang-ju, 500-470,South Korea
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. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

. Trade Name: J2A Dental Implant System
J2C Dental Implant System
Common Name: Dental Implant System
Classification Name: Endosseous Dental Implant
Product Code: DZE, NHA
. Classification regulation: 21CFR872.3640

4. Predicate Device:

Primary Predicate Device: HERO II Dental Implant System by KJ Meditech Co., Ltd. (K121047)
. Reference Predicate Devices: TS Fixture System by OSSTEM IMPLANT CO.,LTD (K121995) GS III SYSTEM by OSSTEM IMPLANT CO.,LTD (K091208)

{4}------------------------------------------------

5. Description:

J2A Dental Implant System

· 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)

J2C Dental Implant System

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) / 11.5mm(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)

There are one-piece abutments which are compatible with both J2A and J2C fixtures with the following features. Only straight abutments are provided.

Material / Surface Treatment	Ti 6Al 4V ELI, ASTM F136 / TiN Coating
Dimensions	Diameter: Ø4mm ~ Ø7mm Cuff: 1mm~~5mm Height: 4.0mm~~7.0mm Connection platform: Narrow platform & Wide platform

There are also two-piece abutments which are compatible with both J2A and J2C fixtures with the following features. Only straight abutments are provided.

Material / Surface Treatment	Ti 6Al 4V ELI, ASTM F136 / TiN Coating
Dimensions	• Diameter: Ø4mm ~ Ø7mm• Cuff: 1mm~~5mm• Height: 4.0mm~~7.0mm• Connection platform: Narrow platform & Wide platform
Cover screws made of Titanium 6Al 4V ELI alloy are also provided both for I2A and I2C

Cover screws made of Titanium 6AL 4V ELI alloy are also provided both for J2A and J2C fixtures.

{5}------------------------------------------------

6. Indication for use:

The J2A Dental Implant System and J2C Dental Implant System are 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 Dental Implant System and J2C Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

{6}------------------------------------------------

7. Basis for Substantial Equivalence

7.1. Fixtures and Cover Screws

The I2A Dental Implant and J2C Dental Implant have the identified predicate devices. They are similar in fundamental scientific technology in that they are all threaded root form implants constructed of titanium with RBM roughened surfaces. They all share same internal hexagon abutment connection system with interface. The subject and predicate devices are both bone-level implants that share similar body shape design walled neck and tapered body design.

The manufacturing facility, raw materials for the surface treatments (RBA treatment), surface treatment method, manufacturing process, and cleaning process of the J2A and I2C Dental Implant are identical to the predicate device (Hero I and IS Dental Implant System, K121047).

Item	Subject Device(Modified Device 1)	Subject Device(Modified Device 2)	Primary PredicateDevice(Unmodified Device)	Reference PredicateDevice 1	Reference Predicate Device 2
510(K) Number	K150060	K150060	K121047	K121995	K091208
Device Name	J2A Dental ImplantSystem	J2C Dental ImplantSystem	HERO II DentalImplant System	TS Fixture System	GS III SYSTEM
Manufacturer	KJ Meditech Co., Ltd.	KJ Meditech Co., Ltd.	KJ Meditech Co., Ltd.	OSSTEM IMPLANTCO.,LTD	OSSTEM IMPLANTCO.,LTD
Indications forUse	The J2A DentalImplant System isindicated for use inpartially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple-unitrestorations including;cemented retained,	The J2C Dental ImplantSystem is indicated foruse in partially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple-unitrestorations including;cemented retained,screw retained, or	The HERO II DentalImplant System isindicated for use inpartially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple-unitrestorations including;cemented retained,	The TS Fixture Systemis indicated for use inpartially or fullyedentulous mandiblesand maxillae, in supportof single or multiple-unitrestorations including;cemented retained,screw retained, oroverdenture restorations,	The GS III System is indicatedfor use in partially or fuhllyedentulous mandibles andmaxillae, in support of singleor multiple-unit restorationsincluding; cemented retained,screw retained, or overdent-ure restorations, and terminalor intermediate abutmentsupport for fixed bridgework.
	screw retained, oroverdenturerestorations, andterminal orintermediate abutmentsupport for fixedbridgework. The J2ADental Implant Systemis for single and twostage surgicalprocedures. The systemis intended for delayedloading.	overdenturerestorations, andterminal orintermediate abutmentsupport for fixedbridgework. The J2CDental Implant Systemis for single and twostage surgicalprocedures. The systemis intended for delayedloading.	screw retained, oroverdenturerestorations, andterminal orintermediate abutmentsupport for fixedbridgework. The HEROII Dental ImplantSystem is for single andtwo stage surgicalprocedures. The systemis intended for delayedloading.	and final or temporaryabutment support forfixed bridgework. It isintended for delayedloading.TS Fixture System iscompatible withabutment in the ET/SSImplantSystem.	The GS II System is for singleand two stage surgicalprocedures.It is not for immediate load.
Design	• Implant Type: BoneLevel Implant• Connection Type:Internal Hexagon• Neck Design:Straight walled neck• Body Design:Tapered design	• Implant Type: BoneLevel Implant• Connection Type:Internal Hexagon• Neck Design:Straight walled neckwith micro-thread	• Implant Type: BoneLevel Implant• Connection Type:Internal Hexagon• Neck Design:Straight walled neck• Body Design:Tapered design	• Implant Type: BoneLevel Implant• Connection Type:Internal Hexagon• Neck Design: Straightwalled neck• Body Design:Tapered design	• Implant Type: Bone LevelImplant• Connection Type:Internal Hexagon• Neck Design: Straightwalled neck with micro-thread• Body Design:Tapered design
Appearance	Image: Implant 1	Image: Implant 2	Image: Implant 3	Image: Implant 4	Image: Implant 5
EndosseousImplant Material	Ti 6Al 4V ELI, ASTMF136	Ti 6Al 4V ELI, ASTMF136	Ti 6Al 4V ELI, ASTMF136	Grade 4 Pure Titanium(ASTM F67)	Grade 4 Pure Titanium(ASTM F67)
SurfaceTreatment	RBM Treatment	RBM Treatment	RBM Treatment	SA Treatment	SA Treatment
SterilizationMethod	Same - Nomodification	Same - Nomodification	Gamma	Gamma	Gamma
ImplantDiameters	3.75mm, 4.0mm,4.3mm, 4.5mm, 5.0mm, 5.5mm, 6.0mm	3.75mm, 4.0mm,4.3mm, 4.5mm, 5.0mm, 5.5mm, 6.0mm	3.75mm, 4.0mm,4.5mm, 5.0 mm,6.0mm	3.75mm, 3.77mm,4.2mm, 4.25mm,4.6mm, 4.63mm,4.65mm, 5.05mm,5.08mm, 5.1mm	3.75mm~5.1mm
Implant Lengths	7.0mm - 15.0 mm	7.0mm - 15.0 mm	8.5mm - 15.0 mm	7.0mm - 15.0 mm	7.0 - 15.0 mm
Cover Screw	Image: Ti 6Al 4V ELI, ASTM F136	Image: Ti 6Al 4V ELI, ASTM F136	Image: Ti 6Al 4V ELI, ASTM F136	Image: Ti 6Al 4V ELI, ASTM F136/Anodizing	-

510(k) Submission.

510(k) summary , 4 / 9 page

{7}------------------------------------------------

510(k) Submission.

510(k) summary , 5 / 9 page

{8}------------------------------------------------

7.2. Abutments

The I2A and J2C Abutments have the same intentified predicate devices. They are similar in fundamental scientific technology and design. The subject and the predicate devices offer one-piece as well as two-piece type abutments.

The manufacturing facility, raw materials for the surface treatments (TiN coating), surface treatment method, manufacturing process, and cleaning process of the J2A and J2C Abutments are identical to the predicate device (Hero I and IS Dental Implant System, K121047).

Item	Subject Device(Modified Device)	Primary Predicate Device(Unmodified Device)	Reference Predicate Device
510(K) Number	K150060	K121047	K121995
Device Name	J2A and J2C Dental Implant System	HERO II Dental Implant System	TS Fixture System

510(k) Submission.

{9}------------------------------------------------

Manufacturer	KJ Meditech Co., Ltd.	KJ Meditech Co., Ltd.	OSSTEM IMPLANT CO.,LTD
Indications forUse	The J2A and J2C Dental ImplantSystems are indicated for use inpartially or fully edentulousmandibles and maxillae, in supportof single or multiple-unitrestorations including; cementedretained, screw retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework. TheJ2A and J2C Dental ImplantSystems are for single and two stagesurgical procedures. The system isintended for delayed loading.	The HERO II Dental Implant Systemis indicated for use in partially or fullyedentulous mandibles and maxillae, insupport of single or multiple-unitrestorations including; cementedretained, screw retained, oroverdenture restorations, and terminalor intermediate abutment support forfixed bridgework. The HERO II DentalImplant System is for single and twostage surgical procedures. The systemis intended for delayed loading.	The TS Fixture System is indicatedfor use in partially or fullyedentulous mandibles and maxillae,in support of single or multiple-unitrestorations including; cementedretained, screw retained, oroverdenture restorations, and finalor temporary abutment support forfixed bridgework. It is intended fordelayed loading.TS Fixture System is compatiblewith abutment in the ET/SS ImplantSystem.
One PieceAbutment	• Ti 6Al 4V ELI, ASTM F136 /TiN Coating (Entire body)• Diameter: Ø4mm ~ Ø7mmCuff: 1mm~~5mmHeight: 4.0mm~~7.0mm	• Ti 6Al 4V ELI, ASTM F136 / TiNCoating (Partial)• Diameter: Ø4mm ~ Ø6mmCuff: 1mm~~4mmHeight: 4.0mm~~7.0mm	• Ti 6Al 4V ELI, ASTM F136 /TiN Coating (Partial)• Diameter: Ø4mm ~ Ø7mmCuff: 1mm~~5mmHeight: 4.0mm~~7.0mm

{10}------------------------------------------------

Two PieceAbutment	Image: Dental abutment and screwTi 6Al 4V ELI, ASTM F136 /TiN Coating (Entire body) Diameter: Ø4mm ~ Ø7mm Cuff: 1mm~~5mm Height: 4.0mm~~7.0mm	Image: Dental abutment and screwTi 6Al 4V ELI, ASTM F136 / TiNCoating (Entire body) Diameter: Ø4mm ~ Ø7mm Cuff: 1mm~~4mm Height: 4.0mm~~7.0mm	Image: Dental abutment and screwTi 6Al 4V ELI, ASTM F136 /TiN Coating (Entire body) Diameter: Ø4mm ~ Ø7mm Cuff: 1mm~~5mm Height: 4.0mm~~7.0mm
-----------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------

{11}------------------------------------------------

8. Non-Clinical Testing

Risk analysis was conducted according to ISO14971 to demonstrate that the following modifications to the company's own predicate, Hero II Dental Implant System (K121047) is substantially equivalent:

Fixture thread design change ●
. Fixture size addition
Coating area expansion for one-piece type abutments
Abutment size addition .

Additional predicate devices of similar design and dimensions were identified to determine substantial equivalence. In addition, based on the risk analysis the shelf-life, sterilization, biocompatibility, and performance testing of the predicate, Hero II Dental Implant System (K121047), is applicable to the subject device.

9. Conclusion

The subject devices and the predicate device have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of commercially pure titanium and have the same surface treatments.

Overall, the J2A Dental Implant system and the J2C Dental Implant system have the following similarities to the predicate device:

- have the same intended use,
- use the same operating principle,
- incorporate the same basic design,
- incorporate the same material and the surface treatment.

Based on the similarities, we conclude that the J2A Dental Implant system and the J2C Dental Implant system are substantially equivalent to the predicate devices.

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.