Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental implant system made of ZIRCONIA and does not mention any AI or ML components or functionalities.

Therapeutic

No
The device restores mastication, but this is a functional restoration rather than a therapeutic treatment for a disease or condition. Its purpose is to support a prosthetic device, not directly treat a medical condition.

Diagnostic

No

Explanation: The device is a dental implant system used to support prosthetic devices for restoring mastication. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a dental implant system made of ZIRCONIA, intended to be surgically placed in bone. This describes a physical hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the KJ ZIRCONIA Implant System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that the device is for the treatment of missing teeth to support prosthetic devices and restore mastication. This is a surgical and restorative procedure performed directly on the patient's body.
Device Description: The device is described as a dental implant system made of ZIRCONIA, surgically placed in the bone. This is a physical implant, not a reagent, instrument, or system intended for use in vitro (outside the body) for the examination of specimens derived from the human body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in the body, or providing diagnostic information based on in vitro testing.

IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases, monitor health, or screen for conditions. The KJ ZIRCONIA Implant System is a medical device used for surgical implantation and prosthetic support.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DZE

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bone of the upper or lower jaw arches

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

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 on the endotoxin limit which is 0.5 EU/mL

Key Metrics

Not Found

Predicate Device(s)

K061971

Reference Device(s)

K151328

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure. The FDA part of the logo has the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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)

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.

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

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.

4

6. Indication for Use

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.

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 Implant
System	Nobel biocare	PURE Ceramic implant
510k #	K173116	K061971	K151328
Applicant	KJ Meditech Co., Ltd.	Novel biocare
Co., Ltd.	Staumann USA
Indications for Use	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.	Nobel Biocare's Zirconia
Implants are root-form
endosseous dental
implants intended to
be surgically placed in
the bone of the upper or
lower jaw arches to
provide support for
prosthetic devices, such
as an artificial tooth, in
order to restore patient
esthetics and
chewing function. Nobel
Biocare's Zirconia
Implants are indicated for
single or multiple
unit restorations in
splinted or non-splinted
applications. Nobel
Biocare Zirconia
Implants
may be placed
immediately and put into
immediate function
providing that the initial
stability requirements
detailed in the surgical
manual are satisfied.	The Straumann® PURE
Ceramic Implant
(Monotype) is indicated
for restoration in single
tooth gaps and in an
edentulous or partially
edentulous jaw. The
prosthetic restorations
used are single crowns,
fixed partial or full
dentures, which are
connected to the implants
through the
corresponding
components.
The ø3.3 mm reduced
diameter implants are
recommended for central
and lateral incisors only.
The Straumann® PURE
Ceramic Implant
Protective Cap is
intended to protect the
Straumann® PURE
Ceramic Implant
(Monotype) during the
healing phase after
implant placement for up
to 6 months.
Temporary copings are
intended to serve as a
base for temporary crown
or bridge restoration
for the Straumann®

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| (Monotype) for up to 30 |--------------------------- | | Implant Design Piece Type
· Body Design:
Threaded body | • Piece Type
· Body Design:
Threaded body | • Piece Type
· Body Design:
Threaded body |
| | Implant/Abutment
Connection | None (Monotype) | Allowable Angulation | Appearance | Material | Surface Treatment | Implant Sterile | Sterilization Method | Implant Diameters | Implant Lengths 15,16mm | Implant Neck Dimensions | Thread Pitch | Product Code | | | PURE Ceramic Implant
|
-----|----------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|
| | | days. |
| • Implant Type: One
Implant Type: One
Implant Type: One
| | | |
| None (Monotype) | None (Monotype) |
| Angulation not allowed | Angulation not allowed | Angulation not allowed |
| | | |
| Zirconia (ISO 13356) | Zirconia | Zirconia |
| N/A | N/A | N/A |
| Yes | Yes | Yes |
| Gamma | Gamma | Gamma |
| 3.5, 4.0, 4.5, 5.0 | 3.5, 4.3 , 5.0 | 3.3, 4.1 |
| 8, 9, 10, 11, 12, 13, 14,
| 10, 13, 16mm | 8,10,12,14mm |
| 2.6, 2.8, 3.0 | 3.5, 4.3, 5.0 | 3.5 , 48 |
| 1.0mm | | |
| 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 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.