K Number

Device Name

KJ SUBMERGED SYSTEM

Manufacturer

KJ MEDITECH CO., LTD

Date Cleared

2011-09-14

(259 days)

Product Code

DZE

Regulation Number

872.3640

Intended 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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K101849, K092035, K073368, K062044, K050712, K042637, K010185, K994037, K972417

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a mechanical dental implant system made of titanium alloy, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

Yes.
The device is used to replace a missing tooth and supports various dental restorations, indicating its role in treating a medical condition (edentulism) by restoring function and structure.

Diagnostic

No
The device, the KJ Submerged System, is an implantable dental device (replacing the root of a missing tooth) used to support restorations. Its description and intended use indicate it is a therapeutic or restorative device, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description explicitly states the device is made from surgical grade titanium alloy and is comprised of physical components (implant and abutment).

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 that the device is used in partially or fully edentulous mandibles and maxillae to support dental restorations. This is a surgical and prosthetic application within the human body.
Device Description: The description details a dental implant system made of titanium alloy, designed to be surgically placed in the jaw bone.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used outside the body to analyze biological samples. This device is surgically implanted within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DZE

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Mandibles and Maxillae

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)

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.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K101849, K092035, K073368, K062044, K050712, K042637, K010185, K994037, K972417

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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

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	K972417
Bicon Implant System
Manufacturer	KJ Meditech Co., Ltd.	Bicon LLC.
Product Code	DZE	DZE
Indications for Use	Mandible and Maxilla
Endosseous Dental Implant &
Accessories	Mandible and Maxilla
Endosseous Dental Implant &
Accessories
	Design	Fin design
Sloping shoulder
Locking taper	Fin design
Sloping shoulder
Locking taper
Material		Ti 6A1 4V ELI, Gr.23	Ti 6Al 4V ELI, Gr.23
Surface Treatment		RBM Treatment and
HA Coating on the fixture body
No surface treatment on
abutments	RBM Treatment and
HA Coating on the fixture body
No surface treatment on
abutments

510(k) Submission.

| Attachments | Various abutments and
components | Various abutments and
components |

-------------	-------------------------------------	-------------------------------------

6. Non-Clinical Testing

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.

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.

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

Indications for Use

610380 510(k) Number (if known):

Device Name: KJ Submerged System

Indications For Use:

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