Jplant

K211978 · Jj Medical Co., Ltd. · DZE · Jan 5, 2022 · Dental

Device Facts

• Record ID: K211978
• Device Name: Jplant
• Applicant: Jj Medical Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jan 5, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Jplant is intended for use in partially or fully edentulous mandibles and maxilla, 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. Jplant is for single stage and two stage surgical procedures. This system is intended for delayed loading.

Device Story

Jplant is a titanium alloy endosseous dental implant; surgically placed in jaw bone to support prosthetic devices (artificial teeth) and restore chewing function. Device features threaded, root-form design with internal hexagon connection and self-tapping cutting edge threads. Used by dental professionals in clinical settings for single or two-stage surgical procedures. System requires delayed loading. Provides structural foundation for abutments and final restorations. Benefits patient by replacing missing teeth and restoring oral function.

Clinical Evidence

Bench testing only. Includes sterilization validation (ISO 11137), shelf-life validation (ASTM F1980-07, ASTM F88, ISO 11607, ISO 11737-2), surface characterization (XPS, SEM), and biocompatibility testing (ISO 10993-5, -11, -10, -6). Endotoxin testing follows ANSI/AAMI ST72:2011.

Technological Characteristics

Material: Titanium alloy (ASTM F67). Surface: SLA roughened. Connection: Internal hexagon. Design: Threaded, root-form, straight-walled neck, tapered body. Sterilization: Radiation. Dimensions: Various diameters (3.90mm–8.0mm) and lengths (7.0mm–14.0mm).

Indications for Use

Indicated for partially or fully edentulous patients (maxilla/mandible) requiring single or multiple-unit restorations (cemented, screw-retained, or overdenture) or fixed bridgework support. Contraindications not specified.

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

• CHAORUM Implant System (K160536)

Reference Devices

• OneQ-SL s-Clean Implant System (K153639)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

JJ Medical Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine. California 92612

Re: K211978

Trade/Device Name: Jplant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 22, 2021 Received: October 7, 2021

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K211978

Device Name Jplant

Indications for Use (Describe)

Iplant is intended for use in partially or fully edentulous maxilla, in support of single of multiple-unit restorations including cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Jplant is for single stage surgical procedures. This system is intended for delayed loading.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |
| | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

(K211978)

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

# 1. Date: 1/4/2022

## 2. Applicant / Submitter

JJ Medical Co., Ltd. Daeryung Techno Town 3 409 Gasan-Dong, 115, Gasan Digital 2-Ro, Geumcheon-Gu Seoul, Republic of Korea, 08505

## 3. U.S. Designated Agent

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 Tel: [phone] Fax: [phone] Email: [e-mail]

#### 4. Trade/Proprietary Name:

Jplant

#### 5. Common Name:

Endosseous dental implant

#### 6. Classification:

Endosseous dental implant (21CFR 872.3640, Product code DZE, Class 2, Dental)

#### 7. Device Description:

The Jplant is dental implant which is made of titanium alloy 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, and to restore the patients chewing function. The fixture has the following sizes.

{4}------------------------------------------------

Size RP (Regular Platform) Connection Type Fixture 3.90mm Dia. x 7.0mm(L) / 8.0mm (L) / 10.0mm (L) /12.0mm (L) / 14.0mm (L) 4.21mm Dia. x 7.0mm(L) / 8.0mm (L) / 10.0mm (L) / 12.0mm (L) / 14.0mm (L) 4.67mm Dia. x 7.0mm(L) / 8.0mm (L) / 10.0mm (L) / 12.0mm (L) / 14.0mm (L) 5.14mm Dia. x 7.0mm(L) / 8.0mm (L) / 10.0mm (L) /12.0mm (L) / 14.0mm (L) 6.20mm Dia. x 7.0mm(L) / 8.0mm (L) / 10.0mm (L) /12.0mm (L) 7.20mm Dia. x 7.0mm(L) / 8.0mm (L) / 10.0mm (L) /12.0mm(L)

The system includes the cover screw which is the same as the K160536 with a slight difference in size. The cover screw is made of Ti6AL4V ELI, ASTM F136 and offers the size of 3.55mm Dia. x 6.35mm (L).

The Jplant dental implant is intended to be used with abutments cleared under K160536 and manufactured by Medimecca Co., Ltd. JJ Medical Co., Ltd. is a subsidiary company of Medimecca Co., Ltd. and is under the same management, and shares the same manufacturing method and processes.

# 8. Indication for use:

Jplant is intended for use in partially or fully edentulous mandibles and maxilla, 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. Jplant is for single stage and two stage surgical procedures. This system is intended for delayed loading.

#### 9. Predicate Devices:

#### Primary Predicate Device

- Manufacturer: MEDIMECCA Co., Ltd. ●
- Device: CHAORUM Implant System
- 510(k) Number: K160536

# Reference Device

- Manufacturer: Dentis Co., Ltd. ●
- Device: OneQ-SL s-Clean Implant System
- 510(k) Number: K153639 ●

{5}------------------------------------------------

# 10. Substantial Equivalence:

The Jplant has the same intended use as the identified predicate devices. They are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium SLA roughened surfaces. The subject and predicate devices are both bone-level implants that share similar body shape design such as straight walled neck and tapered body design. We identified reference device which covers the size range of the subject device. Based on the information provided herein, we conclude that the subject device is substantially equivalent to the predicate devices.

| Item | Subject Device | Primary Predicate Device | Reference Device |
|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)<br>Number | K211978 | K160536 | K153639 |
| Device<br>Name | Jplant | CHAORUM Implant System | OneQ-SL s-Clean Implant System |
| Manu-<br>facturer | JJ MEDICAL Co., Ltd. | MEDIMECCA Co., Ltd. | Dentis Co., Ltd. |
| Indications<br>for Use | JFT Implant System is intended for<br>use in partially or fully edentulous<br>mandibles and maxilla, in support<br>of single or multiple-unit<br>restorations including; cemented<br>retained, screw retained, or<br>overdenture restorations, and<br>terminal or intermediate abutment<br>support for fixed bridgework.<br>JFT Implant System<br>is for single stage and two stage<br>surgical procedures. This system is<br>intended for delayed loading. | CHAORUM Implant System is<br>intended for use in partially or fully<br>edentulous mandibles and maxilla,<br>in<br>support of single of multiple-unit<br>restorations including; cemented<br>retained, screw retained, or<br>overdenture restorations, and<br>terminal or intermediate abutment<br>support for fixed bridgework.<br>CHAORUM Implant System<br>is for single stage and two stage<br>surgical procedures. This system is<br>intended for delayed loading. | The OneQ-SL s-Clean Implant<br>System is indicated for use in<br>partially or fully edentulous<br>mandibles and maxillae, in support<br>of single or multiple unit<br>restorations including; cemented<br>retained, screw retained, or<br>overdenture restorations, and<br>terminal or intermediate abutment<br>support for fixed bridgework. This<br>system is dedicated for one and two<br>stage surgical procedures. This<br>system is intended for delayed<br>loading. |
| Design<br>/Principle<br>of<br>Operation | Image: JFT Implant System<br>- Internal Hexagon connection<br>- Self-tapping cutting edge threads | Image: CHAORUM Implant System | Image: OneQ-SL s-Clean Implant System<br>- Internal Hex-connected - |
| | | | Tapered & straight body - 3 sided<br>cutting edge with self-tapping |
| | | - Internal Hexagon connection<br>- Self-tapping cutting edge threads | |
| Endosseous<br>Implant<br>Material | Titanium<br>(ASTM F67) | Titanium<br>(ASTM F136, ASTM F67) | Titanium<br>(ASTM F67) |
| Surface<br>Treatment | SLA | RBM,<br>SLA | SLA |
| Implant<br>Sterilization<br>Method | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Implant<br>Diameters<br>x<br>Implant<br>Lengths | 3.90mm Dia. x 7.0mm (L)<br>3.90mm Dia. x 8.0mm (L)<br>3.90mm Dia. x 10.0mm (L)<br>3.90mm Dia. x 12.0mm (L)<br>3.90mm Dia. x 14.0mm (L) | 3.25mm Dia. x 8.0mm(L)<br>3.25mm Dia. x 8.5mm(L)<br>3.25mm Dia. x 10.0mm(L)<br>3.25mm Dia. x 12.0mm(L)<br>3.25mm Dia. x 14.0mm(L)<br>3.25mm Dia. x 15.0mm(L)<br>3.25mm Dia. x 15.5mm(L) | 3.7mm Dia. x 7.0mm (L)<br>3.7mm Dia. x 8.0mm (L)<br>3.7mm Dia. x 10.0mm (L)<br>3.7mm Dia. x 12.0mm (L)<br>3.7mm Dia. x 14.0mm (L) |
| | 4.21mm Dia. x 7.0mm (L)<br>4.21mm Dia. x 8.0mm (L)<br>4.21mm Dia. x 10.0mm (L)<br>4.21mm Dia. x 12.0mm (L)<br>4.21mm Dia. x 14.0mm (L)<br>4.67mm Dia. x 7.0mm (L)<br>4.67mm Dia. x 8.0mm (L) | 3.89mm Dia. x 8.0mm(L)<br>3.89mm Dia. x 10.0mm(L)<br>3.89mm Dia. x 12.0mm(L)<br>3.89mm Dia. x 14.0mm(L) | 3.9mm Dia. x 7.0mm (L)<br>3.9mm Dia. x 8.0mm (L)<br>3.9mm Dia. x 10.0mm (L)<br>3.9mm Dia. x 12.0mm (L)<br>3.9mm Dia. x 14.0mm (L)<br>4.2mm Dia. x 7.0mm (L)<br>4.2mm Dia. x 8.0mm (L) |
| | 4.67mm Dia. x 10.0mm (L)<br>4.67mm Dia. x 12.0mm (L)<br>4.67mm Dia. x 14.0mm (L) | 3.89mm Dia. x 8.0mm(L)<br>3.89mm Dia. x 10.0mm(L)<br>3.89mm Dia. x 12.0mm(L)<br>3.89mm Dia. x 14.0mm(L) | 4.2mm Dia. x 10.0mm (L)<br>4.2mm Dia. x 12.0mm (L)<br>4.2mm Dia. x 14.0mm (L) |
| | 5.14mm Dia. x 7.0mm (L)<br>5.14mm Dia. x 8.0mm (L)<br>5.14mm Dia. x 10.0mm (L)<br>5.14mm Dia. x 12.0mm (L)<br>5.14mm Dia. x 14.0mm (L) | 4.28mm Dia. x 8.0mm(L)<br>4.28mm Dia. x 10.0mm(L)<br>4.28mm Dia. x 12.0mm(L)<br>4.28mm Dia. x 14.0mm(L) | 4.7mm Dia. x 7.0mm (L)<br>4.7mm Dia. x 8.0mm (L)<br>4.7mm Dia. x 10.0mm (L)<br>4.7mm Dia. x 12.0mm (L)<br>4.7mm Dia. x 14.0mm (L) |
| | 6.20mm Dia. x 7.0mm (L)<br>6.20mm Dia. x 8.0mm (L)<br>6.20mm Dia. x 10.0mm (L)<br>6.20mm Dia. x 12.0mm (L) | 4.78mm Dia. x 8.0mm(L)<br>4.78mm Dia. x 10.0mm(L)<br>4.78mm Dia. x 12.0mm(L)<br>4.78mm Dia. x 14.0mm(L) | 5.2mm Dia. x 7.0mm (L)<br>5.2mm Dia. x 8.0mm (L)<br>5.2mm Dia. x 10.0mm (L)<br>5.2mm Dia. x 12.0mm (L)<br>5.2mm Dia. x 14.0mm (L) |
| 7.20mm Dia. x 7.0mm (L)<br>7.20mm Dia. x 8.0mm (L)<br>7.20mm Dia. x 10.0mm (L)<br>7.20mm Dia. x 12.0mm (L) | 5.28mm Dia. x 8.0mm(L)<br>5.28mm Dia. x 10.0mm(L)<br>5.28mm Dia. x 12.0mm(L)<br>5.28mm Dia. x 14.0mm(L) | 6.0mm Dia. x 7.0mm (L)<br>6.0mm Dia. x 8.0mm (L)<br>6.0mm Dia. x 10.0mm (L)<br>6.0mm Dia. x 12.0mm (L) | |
| | 6.28mm Dia. x 8.0mm(L)<br>6.28mm Dia. x 10.0mm(L)<br>6.28mm Dia. x 12.0mm(L)<br>6.28mm Dia. x 14.0mm(L) | 7.0mm Dia. x 7.0mm (L)<br>7.0mm Dia. x 8.0mm (L)<br>7.0mm Dia. x 10.0mm (L)<br>7.0mm Dia. x 12.0mm (L) | |

{6}------------------------------------------------

{7}------------------------------------------------

| 8.0mm Dia. x 7.0mm (L) |
|-------------------------|
| 8.0mm Dia. x 8.0mm (L) |
| 8.0mm Dia. x 10.0mm (L) |
| 8.0mm Dia. x 12.0mm (L) |

# 11. Non-Clinical Testing

- Sterilization validating testing has been performed in accordance with ISO 11137.
- Five year of shelf life has been validated through accelerating testing in accordance with ASTM F1980-07, ASTM F88, ISO 11607, and ISO 11737-2.
- XPS(X-ray Photoelectron Spectroscopy) and SEM(Scanning Electron Microscope) were performed to evaluate the fixture surface characteristics after SLA treatment.
- Biocompatibility information for the subject device is leveraged from the K160536 ● clearance. The following tests were performed under the submission.

| No | Test Title | Test Standard |
|----|-----------------------------------|------------------|
| 1 | Cytotoxicity Test | ISO10993-5:2009 |
| 2 | Acute Systemic Toxicity Test | ISO10993-11:2006 |
| 3 | Intracutaneous Reactivity Test | ISO10993-10:2010 |
| 4 | Pyrogen Test | ISO10993-11:2006 |
| 5 | Local Lymph Node Assay, LLNA Test | ISO10993-10:2010 |
| 6 | Bone Implantation Test | ISO10993-6:2007 |

- The endotoxin testing will be conducted on a random batch every two months for the subject device. We are planning to apply gel-clot technique (limit test and assay method) among currently three commonly accepted BET techniques (ANSI/AAMI ST72:2011, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing. Annex B).
# 12. Conclusion

The subject devices and the predicate device have the same intended use and have similar technological characteristics. The substantial equivalence of the different dimensions between the subject device and predicate device is supported by the reference device.

Overall, the Jplant has the following similarities to the predicate device:

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

Based on the similarities, we conclude that the Jplant is substantially equivalent to the predicate devices.