The KJ Submerged 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. This system is dedicated for one and two stage surgical procedures and not dedicated for immediate loading.

Device Description

The KJ Submerged System replaces the root of a missing tooth and is made from surgical grade titanium alloy(Ti-6Al-4V) to exacting specifications. The KJ Submerged system is comprised of only two components, implant, which is the portion that goes into the jaw bone, and the abutment, which fits into the implant and provides a solid base for a crown or a denture. KJ Submerged System's locking taper provides a tight seal at the implant to abutment interface, minimizing the gap. The sloping shoulder affords felxibility at time of implant placement.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "KJ Submerged System," which is a dental implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria tied to human or AI performance. Therefore, many of the requested elements for a study proving device performance against acceptance criteria for AI/human reader performance are not applicable here.

However, I can extract the relevant information regarding the non-clinical testing performed and the basis for substantial equivalence.

Here's a breakdown of the requested information based on the provided text, with explanations for why certain sections are not applicable:

Acceptance Criteria and Study Details for KJ Submerged System (Dental Implant)

This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of characteristics, rather than a clinical study with detailed acceptance criteria for diagnostic performance or AI effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Strength appropriate for intended use (conformance to ISO 14801)	Results confirmed the strength of the system. (Implied acceptance based on conformance to standard)
Same intended use as predicate device	Has the same intended use (Confirmed through comparison)
Same operating principle as predicate device	Uses the same operating principle (Confirmed through comparison)
Same basic design as predicate device	Incorporates the same basic design (Confirmed through comparison)
Same material and surface treatment as predicate device	Incorporates the same material and the surface treatment (Confirmed through comparison)
Similar range of physical dimensions to predicate device	Encompass the similar range of physical dimensions, including diameter and length of the implants, and diameter and height of the abutments (Confirmed through comparison)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a "test set" in the context of a clinical study or AI model evaluation. The "testing" referred to is non-clinical, specifically mechanical fatigue testing. The sample size for ISO 14801 Dentistry - Implants - Dynamic fatigue tests is not explicitly stated in the provided text, but such standards typically prescribe a minimum number of samples.
Data Provenance: Not applicable as this is a non-clinical, in-vitro mechanical test, not data from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth in this context would refer to objective measurements from mechanical testing, not expert interpretation of diagnostic images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. There was no adjudication of expert opinions; the testing was mechanical.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not performed. This device is a dental implant, and the submission is for substantial equivalence based on non-clinical testing and comparison to predicate devices, not an evaluation of human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This is a physical medical device (dental implant), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was objective physical measurements and adherence to specified performance metrics as defined by the ISO 14801 standard for dynamic fatigue tests of endosseous dental implants.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in this context, as it's a physical device and not an AI or machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device submission.

Summary

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K1038/0

510(k) Summary

1 4 2011 SEP

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

Date: 08/15/2011

l. 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

U.S Agent/Contact Person

LK Consulting Group 951 Starbuck St. Unit J, Fullerton, CA 92833 Priscilla Juhee Chung Phone: 714.869.3080 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

Device

Trade Name: KJ Submerged System Common Name: Dental Implant Classification Name: Endosseous Dental Implant System Product Code: DZE Classification regulation: 21CFR872.3640

2. Predicate Device:

Bicon Implant System by Bicon LLC. (K101849, K092035, K073368, K062044, K050712, K042637, K010185, K994037, K972417)

1. Description:
  The KJ Submerged System replaces the root of a missing tooth and is made from

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surgical grade titanium alloy(Ti-6Al-4V) to exacting specifications. The KJ Submerged system is comprised of only two components, implant, which is the portion that goes into the jaw bone, and the abutment, which fits into the implant and provides a solid base for a crown or a denture. KJ Submerged System's locking taper provides a tight seal at the implant to abutment interface, minimizing the gap. The sloping shoulder affords felxibility at time of implant placement.

1. Indication for use:
  The KJ Submerged 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. This system is dedicated for one and two stage surgical procedures and not dedicated for immediate loading.

Basis for Substantial Equivalence

The KJ Submerged System has same material and indication for use and similar design and technological characteristics as the predicate devices. The KJ Submerged System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

	Subject Device	Predicate Device
510(K) Number	N/A	K101849
		K092035
		K073368
		K062044
		K050712
		K042637
		K010185
		K994037
Device Name	KJ Submerged System	K972417Bicon Implant System
Manufacturer	KJ Meditech Co., Ltd.	Bicon LLC.
Product Code	DZE	DZE
Indications for Use	Mandible and MaxillaEndosseous Dental Implant &Accessories	Mandible and MaxillaEndosseous Dental Implant &Accessories
	Design	Fin designSloping shoulderLocking taper	Fin designSloping shoulderLocking taper
Material		Ti 6A1 4V ELI, Gr.23	Ti 6Al 4V ELI, Gr.23
Surface Treatment		RBM Treatment andHA Coating on the fixture bodyNo surface treatment onabutments	RBM Treatment andHA Coating on the fixture bodyNo surface treatment onabutments

510(k) Submission.

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Attachments	Various abutments andcomponents	Various abutments andcomponents
-------------	-------------------------------------	-------------------------------------

6. Non-Clinical Testing

Testing was performed in conformance to ISO 14801 Dentistry - Implants - Dynamic fatigue tests for endosseous dental implants to ensure that the strength of the KJ Submerged System is appropriate for the intended use. Results confirmed the strength of the system.

7. Conclusion

The subject device 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. The subject and predicate device encompass the similar range of physical dimensions, including diameter and length of the implants, and diameter and height of the abuments.

Overall, KJ Submerged System has the following similarities to the predicate device:

- has the same intended use,
- uses the same operating principle,
- incorporates the same basic design,
- incorporates the same material and the surface treatment.

Based on the similarities and the test result of the fatigue test, we conclude that the KJ Submerged System is as safe and effective for its intended use and performs as well as the predicate device.

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

KJ Meditech Company, Limited C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group 951 Starbuck Street. Unit J Fullerton, California 92833

1 4 2011

Re: K103810

Trade/Device Name: KJ Submerged System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 9, 2011 Received: September 13, 2011

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 111 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 531-342 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm1.15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

610380 510(k) Number (if known):

Device Name: KJ Submerged System

Indications For Use:

The KJ Submerged System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented mandlord, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures and not dedicated for immediate loading.

Prescription Use V (Per 21 CFR 801 Subpart D)

AND

Over-The Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103800

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.