The KJ ZIRCONIA Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. It is for delayed loading.

Device Description

KJ ZIRCONIA Implant System is a dental implant system made of ZIRCONIA intended to be surgically placed in the bone of the upper or lower jaw arches. It is one piece type implant which the implant and the abutment are manufactured as one piece. It offers two types: BL type and BS type, and the difference is only in the length of the abutment part.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a dental implant system. It primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting performance data from a clinical or algorithm-based study for an AI/ML device. Therefore, it does not contain the information needed to answer your request about acceptance criteria and study proving performance for an AI/ML device.

Here's why the document doesn't provide the requested information:

Device Type: The "KJ ZIRCONIA Implant System" is a physical medical device (a dental implant), not an AI/ML software device.
Regulatory Pathway: A 510(k) submission for this type of device typically demonstrates equivalency to existing predicate devices based on design, materials, and intended use, supported by non-clinical testing (e.g., sterilization, biocompatibility, mechanical properties). It does not usually involve clinical performance studies in the way an AI/ML diagnostic or prognostic device would.
Absence of AI/ML Specifics: There is no mention of algorithms, machine learning models, test sets, ground truth establishment by experts, or MRMC studies, which are all pertinent to evaluating AI/ML product performance.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set details) from this document as it pertains to an AI/ML device.

Summary

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June 28, 2018

KJ Meditech Co., Ltd % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine, California 92620

Re: K173116

Trade/Device Name: KJ ZIRCONIA Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: May 24, 2018 Received: May 30, 2018

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.

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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 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.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K173116

Device Name KJ ZIRCONIA Implant System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X 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)

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510(k) Summary (K173116)

Date: 06/28/2018

1. Submitter

KJ Meditech Co., Ltd. 21, Cheomdan Venture-ro 40 Beon-gil, Buk-gu Gwangju, Jeonranamdo, Republic of Korea 500-470

2. U.S Agent/Contact Person

Priscilla Chung / Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Phone: 714.202.5789Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

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

4. Predicate Device

Predicate Device: ● Nobel Biocare (K061971) by Novel Biocare Co., Ltd.
Reference Device: PURE Ceramic Implant (K151328) by Staumann USA

5. Description

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6. Indication for Use

7. Basis for Substantial Equivalence

The indications for use statement of the subject device does not use exactly the same words as the predicate and the reference devices; however, the statements have the same indications for use which is treatment of missing teeth.

The subject device is substantially equivalent to the predicate and the reference devices in terms of design and material. The size range of the predicate device covers that of the subject device.

	Subject Device	Predicate Device	Reference Device
Device Name	KJ ZIRCONIA ImplantSystem	Nobel biocare	PURE Ceramic implant
510k #	K173116	K061971	K151328
Applicant	KJ Meditech Co., Ltd.	Novel biocareCo., Ltd.	Staumann USA
Indications for Use	The KJ ZIRCONIAImplant System isintended to use in thetreatment of missing teethto support prostheticdevice, such as artificialteeth, in order to restoremastication in partiallyedentulous patients.It is for delayed loading.	Nobel Biocare's ZirconiaImplants are root-formendosseous dentalimplants intended tobe surgically placed inthe bone of the upper orlower jaw arches toprovide support forprosthetic devices, suchas an artificial tooth, inorder to restore patientesthetics andchewing function. NobelBiocare's ZirconiaImplants are indicated forsingle or multipleunit restorations insplinted or non-splintedapplications. NobelBiocare ZirconiaImplantsmay be placedimmediately and put intoimmediate functionproviding that the initialstability requirementsdetailed in the surgicalmanual are satisfied.	The Straumann® PURECeramic Implant(Monotype) is indicatedfor restoration in singletooth gaps and in anedentulous or partiallyedentulous jaw. Theprosthetic restorationsused are single crowns,fixed partial or fulldentures, which areconnected to the implantsthrough thecorrespondingcomponents.The ø3.3 mm reduceddiameter implants arerecommended for centraland lateral incisors only.The Straumann® PURECeramic ImplantProtective Cap isintended to protect theStraumann® PURECeramic Implant(Monotype) during thehealing phase afterimplant placement for upto 6 months.Temporary copings areintended to serve as abase for temporary crownor bridge restorationfor the Straumann®

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			PURE Ceramic Implant(Monotype) for up to 30
			days.
Implant Design	• Implant Type: OnePiece Type· Body Design:Threaded body	• Implant Type: OnePiece Type· Body Design:Threaded body	• Implant Type: OnePiece Type· Body Design:Threaded body

Implant/AbutmentConnection	None (Monotype)	None (Monotype)	None (Monotype)
Allowable Angulation	Angulation not allowed	Angulation not allowed	Angulation not allowed
Appearance
Material	Zirconia (ISO 13356)	Zirconia	Zirconia
Surface Treatment	N/A	N/A	N/A
Implant Sterile	Yes	Yes	Yes
Sterilization Method	Gamma	Gamma	Gamma
Implant Diameters	3.5, 4.0, 4.5, 5.0	3.5, 4.3 , 5.0	3.3, 4.1
Implant Lengths	8, 9, 10, 11, 12, 13, 14,15,16mm	10, 13, 16mm	8,10,12,14mm
Implant Neck Dimensions	2.6, 2.8, 3.0	3.5, 4.3, 5.0	3.5 , 48
Thread Pitch	1.0mm
Product Code	DZE	DZE	DZE

8. Non-Clinical Testing

Sterilization validating testing in accordance with ISO11137 VDmax25, EN552, and ISO 11137
Real time shelf tests to validate the sterility of the device through the proposed shelf . life have been conducted for three (3) years. The testing includes visual, label, seal inspections (ASTM F88), dye penetration (ISO 11607-1) and microbial challenge (ISO11737-2).
Biocompatibility tests in accordance with ISO 10993-3 and ISO 10993-6 ●
Endotoxin Testing in accordance with USP 39 <85> on the endotoxin limit which is ● 0.5 EU/mL

The tests above support that the differences which the subject device might have when comparing to the predicate devices such as in sterilization parameters, packaging configuration, and manufacturing processes do not raise a question in substantial equivalence.

9. Conclusion

Based on the information provided, the subject device is 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.