J2A SLA Dental Implant System

K161923 · Kj Meditech Co., Ltd. · DZE · Nov 9, 2017 · Dental

Device Facts

• Record ID: K161923
• Device Name: J2A SLA Dental Implant System
• Applicant: Kj Meditech Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Nov 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The J2A SLA Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The J2A SLA Dental Implant System is for single and two stage surgical procedures. These systems are intended for delayed loading.

Device Story

Internal hexagon dental implant system; surgically placed in maxilla or mandible bone; replaces missing teeth; supports single/multiple-unit restorations or fixed bridgework. Device features titanium alloy body with SLA (sandblasted, large-grit, acid-etched) surface treatment. Used by dental surgeons in clinical settings for single or two-stage surgical procedures; requires delayed loading. Provides structural foundation for prosthetic restorations; improves patient masticatory function and aesthetics.

Clinical Evidence

Bench testing only. Evidence includes SEM surface analysis, EDS surface chemistry, biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity per ISO 10993), sterilization validation (ISO 11137), and shelf-life testing (ASTM F88, ISO 11607). Endotoxin levels verified below 0.5 EU/mL per USP <85>.

Technological Characteristics

Material: Titanium 6Al 4V ELI (ASTM F136). Design: Internal hexagon, bone-level, tapered body. Surface: SLA (sandblasted, large-grit, acid-etched). Sterilization: Gamma radiation. Dimensions: 3.75mm–6.0mm diameter; 7mm–15mm length.

Indications for Use

Indicated for partially or fully edentulous adult patients requiring single or multiple-unit dental restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support.

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

• J2A Dental Implant System, J2C Dental Implant System (K150060)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and health.

Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 9, 2017

KJ Meditech Co., Ltd. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, California 92620

Re: K161923

Trade/Device Name: J2A SLA Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 7, 2017 Received: October 10, 2017

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.

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

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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 devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mary S. Runner -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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## Indications for Use

510(k) Number (if known) K161923

Device Name J2A SLA Dental Implant System

#### Indications for Use (Describe)

The J2A SLA Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The J2A SLA Dental Implant System is for single and two stage surgical procedures. These systems are intended for delayed loading.

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

| <span style="font-size:100%;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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#### 510(k) Summary (K161923)

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

Date: 11/09/2017

#### 1. Submitter

| | Submitter |
|---------|---------------------------------------------------------------------------------------------------|
| Name | KJ Meditech Co., Ltd. |
| Address | 21, Cheomdan Venture-ro<br>40 Beon-gil, Buk-gu<br>Gwangju, Jeonranamdo, Republic of Korea 500-470 |
| Phone | [phone] |
| Fax | [phone] |
| Contact | Huykki Moon, CEO |

### 2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine CA 92620 Phone: [phone] Fax: [phone] Email: [e-mail]

### 3. Device

- Trade Name: J2A SLA Dental Implant System ●
- Common Name: Dental Implant System
- Classification Name: Endosseous Dental Implant System ●
- Product Code: DZE, NHA ●
- . Classification regulation: 21CFR872.3640

### 4. Predicate Device:

J2A Dental Implant System, J2C Dental Implant System (K150060) by KJ Meditech Co., Ltd.

### 5. Description:

The J2A SLA Dental Implant System is internal hexagon type dental implant systems made

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of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the system has been treated with SLA (sandblasted, Large- grit, Acid-etched). The size information is as below.

- · 3.75mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- · 4.00mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- · 4.30mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- · 4.50mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- 5.00mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L) · 5.50mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- · 6.00mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)

#### 6. Indication for use:

The J2A SLA Dental Implant 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. The J2A SLA Dental Implant System is for single and two stage surgical procedures. The system is intended for delayed loading.

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### 7. Basis for Substantial Equivalence

| Item | Subject Device | Predicate Device | Appearance | Image: Dental implants with SLA Treatment | Image: Dental implants with RBM Treatment |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------------------------------------------------------|---------------------------------------------------------|
| 510(K) Number | - | K150060 | Endosseous Implant<br>Material | Ti 6A1 4V ELI, ASTM F136 | Ti 6Al 4V ELI, ASTM F136 |
| Device Name | J2A SLA Dental Implant | J2A Dental Implant System,<br>J2C Dental Implant System | Surface Treatment | SLA Treatment | RBM Treatment |
| Manufacturer | KJ Meditech Co., Ltd. | KJ Meditech Co., Ltd. | Sterilization Method | Gamma | Gamma |
| Indications for Use | The J2A SLA Dental Implant<br>System is indicated for use in<br>partially or fully edentulous<br>mandibles and maxillae, in<br>support of single or multiple-<br>unit restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal or<br>intermediate abutment<br>support for fixed bridgework.<br>The J2A SLA Dental Implant<br>is for single and two stage<br>surgical procedures. The<br>system is intended for<br>delayed loading. | The J2A Dental Implant<br>System, J2C Dental Implant<br>System are indicated for use<br>in partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple-unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal or<br>intermediate abutment<br>support for fixed<br>bridgework. The J2A Dental<br>Implant System, J2C Dental<br>Implant System are for<br>single and two stage surgical<br>procedures. These systems<br>are intended for delayed<br>loading. | Implant Diameters | 3.75mm, 4.0mm, 4.3mm,<br>4.5mm, 5.0 mm, 5.5mm,<br>6.0mm | 3.75mm, 4.0mm, 4.3mm,<br>4.5mm, 5.0 mm, 5.5mm,<br>6.0mm |
| Design | • Implant Type: Bone Level<br>Implant<br>• Connection Type: Internal<br>Hexagon<br>• Neck Design: Straight<br>walled neck<br>• Body Design: Tapered<br>design | • Implant Type: Bone Level<br>Implant<br>• Connection Type: Internal<br>Hexagon<br>• Neck Design: Straight<br>walled neck with micro-<br>thread<br>• Body Design: Tapered<br>design | Implant Lengths | 7mm – 15.0 mm | 7mm – 15.0 mm |

The J2A SLA Dental Implant System has the same intended use and technical characteristics as the unmodified device. They are exactly identical except the surface treatment.

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### 8. Non-Clinical Testing

Risk analysis was conducted according to ISO14971 to evaluate the effect of the modification which is surface treatment change from RBM to SLA for fixtures. Through risk analysis and the following validation/verification tests, we conclude that the J2ASLA Dental Implant System is substantially equivalent to the unmodified device.

The following tests were carried out:

- SEM surface analysis
- EDS Surface chemistry analysis
- Cytotoxicity test (10993-5)
- Skin sensitization test (10993-10)
- Intracutaneous reactivity test (10993-10)
- Sterilization validation test (ISO 11137-1 & ISO 11137-2)

- Shelf life validation test: visual inspection, label, seal inspections (ASTMF88), dye penetration (ISO 11607-1 & 11607-2) and microbial challenge (ISO11737-2). Fatigue testing was not conducted because the subject device does not have an angled abutment.

The USP <85> test method will be used to evaluate pyrogen limit specifications for the subject device. The endotoxin testing will be conducted on every batch for the subject device and the testing limit will be below 0.5 EU/mL. We referenced the USP 39 <85> to device on the endotoxin limit which is 0.5 EU/mL.

### 9. Conclusion

The subject devices and the predicate device have the same intended use and have the same technological characteristics.

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Overall, the J2A SLA Dental Implant system has the following similarities to the predicate device:

- * have the same intended use,
- * use the same operating principle,
- * incorporate the same design,
- * incorporate the same material and the sterilization method.

Based on the similarities, we conclude that the J2A SLA Dental Implant system is substantially equivalent to the predicate device.