KJ ZIRCONIA Implant System

K173116 · Kj Meditech Co., Ltd. · DZE · Jun 28, 2018 · Dental

Device Facts

• Record ID: K173116
• Device Name: KJ ZIRCONIA Implant System
• Applicant: Kj Meditech Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jun 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

KJ ZIRCONIA Implant System is a one-piece endosseous dental implant; manufactured from zirconia; surgically placed into upper or lower jaw bone to support prosthetic devices. Device features threaded body; available in two types (BL and BS) differing by abutment length. Intended for delayed loading in partially edentulous patients. Used by dental clinicians in clinical settings. Provides structural support for artificial teeth; restores mastication function. Benefits patient by replacing missing teeth with biocompatible ceramic material.

Clinical Evidence

No clinical data. Evidence is based on bench testing, including sterilization validation (ISO 11137, EN 552), real-time shelf-life testing (3 years), packaging integrity (ASTM F88, ISO 11607-1), microbial challenge (ISO 11737-2), biocompatibility (ISO 10993-3, ISO 10993-6), and endotoxin testing (USP 39 <85>).

Technological Characteristics

Material: Zirconia (ISO 13356). Design: One-piece (monotype) threaded endosseous implant. Dimensions: Diameters 3.5-5.0mm; Lengths 8-16mm. Sterilization: Gamma radiation. No surface treatment. Standalone device.

Indications for Use

Indicated for partially edentulous patients requiring treatment of missing teeth to support prosthetic devices (e.g., artificial teeth) for restoration of mastication. For delayed loading.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Nobel Biocare (K061971)

Reference Devices

• PURE Ceramic Implant (K151328)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone]Fax: [phone] Email: [e-mail]

#### 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.

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

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| | | | PURE Ceramic Implant<br>(Monotype) for up to 30 |
|--------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|
| | | | days. |
| Implant Design | • Implant Type: One<br>Piece Type<br>· Body Design:<br>Threaded body | • Implant Type: One<br>Piece Type<br>· Body Design:<br>Threaded body | • Implant Type: One<br>Piece Type<br>· Body Design:<br>Threaded body |
| | | | |
| Implant/Abutment<br>Connection | 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,<br>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.