Jplant 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.

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 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.

AI/ML Overview

This document, a 510(k) summary for the Jplant endosseous dental implant, does not describe a study that proves the device meets specific acceptance criteria related to its performance in a clinical setting or against an AI-driven benchmark.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, not on proving device performance against detailed acceptance criteria in the manner of an AI/ML device study.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as they pertain to clinical or AI performance studies that were not conducted or described here.

Here's a breakdown of what can be extracted based on the provided text, indicating "Not Applicable (N/A)" for information that isn't present or relevant to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify performance-based acceptance criteria for a device, nor does it provide performance metrics in the way an AI/ML device would (e.g., sensitivity, specificity, accuracy). Instead, it establishes substantial equivalence to predicate devices based on design, materials, manufacturing, and intended use.

Acceptance Criteria Category	Acceptance Criteria (Not Explicitly Stated as Numerical AC)	Reported Device Performance (as demonstrated for Substantial Equivalence)
Intended Use	Same as predicate device	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. (Matches predicate)
Technological Characteristics	Similar to predicate devices (e.g., threaded, root form implants, titanium, SLA roughened surfaces, bone-level, similar body shape)	Internal Hexagon connection, self-tapping cutting edge threads; Made of Titanium (ASTM F67); SLA Surface treatment; Radiation Sterile. (Demonstrated to be similar to predicates)
Safety - Biocompatibility	Meets ISO 10993 standards and other relevant standards specified in predicate K160536.	Biocompatibility information leveraged from K160536, including tests for Cytotoxicity, Acute Systemic Toxicity, Intracutaneous Reactivity, Pyrogen, Local Lymph Node Assay (LLNA), and Bone Implantation. Endotoxin testing will be conducted.
Safety - Sterilization	In accordance with ISO 11137.	Sterilization validating testing performed in accordance with ISO 11137.
Safety - Shelf Life	5-year shelf life validated per specified ASTM/ISO standards.	Five-year shelf life validated through accelerating testing in accordance with ASTM F1980-07, ASTM F88, ISO 11607, and ISO 11737-2.
Material Characterization	Surface characteristics evaluated.	XPS and SEM performed to evaluate fixture surface characteristics after SLA treatment.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

N/A. The document does not describe a clinical test set or a dataset for performance evaluation. The "tests" mentioned are non-clinical (e.g., sterilization, shelf life, biocompatibility) and do not involve patient data in a "test set" context for device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This information is not relevant to the type of non-clinical testing and substantial equivalence demonstration presented.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. No test set or expert adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This device is an endosseous dental implant, not an AI/ML diagnostic or assistive device for human readers. No MRMC study was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A. As above, this is not an AI/ML algorithm-driven device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

N/A. For the non-clinical tests, "ground truth" would be the standard scientific methods and established procedures for evaluating materials, sterilization, and biocompatibility, as defined by the referenced ISO and ASTM standards. There is no "ground truth" related to clinical outcomes or expert consensus on findings as would be seen in an AI performance study.

8. The sample size for the training set

N/A. There is no training set mentioned or implied for this mechanical implant device.

9. How the ground truth for the training set was established

N/A. There is no training set for this device.

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). 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.

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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) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com

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:

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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:

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 ●

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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)Number	K211978	K160536	K153639
DeviceName	Jplant	CHAORUM Implant System	OneQ-SL s-Clean Implant System
Manu-facturer	JJ MEDICAL Co., Ltd.	MEDIMECCA Co., Ltd.	Dentis Co., Ltd.
Indicationsfor Use	JFT Implant System is intended foruse in partially or fully edentulousmandibles and maxilla, in supportof single or multiple-unitrestorations including; cementedretained, screw retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework.JFT Implant Systemis for single stage and two stagesurgical procedures. This system isintended for delayed loading.	CHAORUM Implant System isintended for use in partially or fullyedentulous mandibles and maxilla,insupport of single of multiple-unitrestorations including; cementedretained, screw retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework.CHAORUM Implant Systemis for single stage and two stagesurgical procedures. This system isintended for delayed loading.	The OneQ-SL s-Clean ImplantSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, in supportof single or multiple unitrestorations including; cementedretained, screw retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework. Thissystem is dedicated for one and twostage surgical procedures. Thissystem is intended for delayedloading.
Design/PrincipleofOperation	Image: JFT Implant System- Internal Hexagon connection- Self-tapping cutting edge threads	Image: CHAORUM Implant System	Image: OneQ-SL s-Clean Implant System- Internal Hex-connected -
			Tapered & straight body - 3 sidedcutting edge with self-tapping
		- Internal Hexagon connection- Self-tapping cutting edge threads
EndosseousImplantMaterial	Titanium(ASTM F67)	Titanium(ASTM F136, ASTM F67)	Titanium(ASTM F67)
SurfaceTreatment	SLA	RBM,SLA	SLA
ImplantSterilizationMethod	Radiation Sterile	Radiation Sterile	Radiation Sterile
ImplantDiametersxImplantLengths	3.90mm Dia. x 7.0mm (L)3.90mm Dia. x 8.0mm (L)3.90mm Dia. x 10.0mm (L)3.90mm Dia. x 12.0mm (L)3.90mm Dia. x 14.0mm (L)	3.25mm Dia. x 8.0mm(L)3.25mm Dia. x 8.5mm(L)3.25mm Dia. x 10.0mm(L)3.25mm Dia. x 12.0mm(L)3.25mm Dia. x 14.0mm(L)3.25mm Dia. x 15.0mm(L)3.25mm Dia. x 15.5mm(L)	3.7mm Dia. x 7.0mm (L)3.7mm Dia. x 8.0mm (L)3.7mm Dia. x 10.0mm (L)3.7mm Dia. x 12.0mm (L)3.7mm Dia. x 14.0mm (L)
	4.21mm Dia. x 7.0mm (L)4.21mm Dia. x 8.0mm (L)4.21mm Dia. x 10.0mm (L)4.21mm Dia. x 12.0mm (L)4.21mm Dia. x 14.0mm (L)4.67mm Dia. x 7.0mm (L)4.67mm Dia. x 8.0mm (L)	3.89mm Dia. x 8.0mm(L)3.89mm Dia. x 10.0mm(L)3.89mm Dia. x 12.0mm(L)3.89mm Dia. x 14.0mm(L)	3.9mm Dia. x 7.0mm (L)3.9mm Dia. x 8.0mm (L)3.9mm Dia. x 10.0mm (L)3.9mm Dia. x 12.0mm (L)3.9mm Dia. x 14.0mm (L)4.2mm Dia. x 7.0mm (L)4.2mm Dia. x 8.0mm (L)
	4.67mm Dia. x 10.0mm (L)4.67mm Dia. x 12.0mm (L)4.67mm Dia. x 14.0mm (L)	3.89mm Dia. x 8.0mm(L)3.89mm Dia. x 10.0mm(L)3.89mm Dia. x 12.0mm(L)3.89mm Dia. x 14.0mm(L)	4.2mm Dia. x 10.0mm (L)4.2mm Dia. x 12.0mm (L)4.2mm Dia. x 14.0mm (L)
	5.14mm Dia. x 7.0mm (L)5.14mm Dia. x 8.0mm (L)5.14mm Dia. x 10.0mm (L)5.14mm Dia. x 12.0mm (L)5.14mm Dia. x 14.0mm (L)	4.28mm Dia. x 8.0mm(L)4.28mm Dia. x 10.0mm(L)4.28mm Dia. x 12.0mm(L)4.28mm Dia. x 14.0mm(L)	4.7mm Dia. x 7.0mm (L)4.7mm Dia. x 8.0mm (L)4.7mm Dia. x 10.0mm (L)4.7mm Dia. x 12.0mm (L)4.7mm Dia. x 14.0mm (L)
	6.20mm Dia. x 7.0mm (L)6.20mm Dia. x 8.0mm (L)6.20mm Dia. x 10.0mm (L)6.20mm Dia. x 12.0mm (L)	4.78mm Dia. x 8.0mm(L)4.78mm Dia. x 10.0mm(L)4.78mm Dia. x 12.0mm(L)4.78mm Dia. x 14.0mm(L)	5.2mm Dia. x 7.0mm (L)5.2mm Dia. x 8.0mm (L)5.2mm Dia. x 10.0mm (L)5.2mm Dia. x 12.0mm (L)5.2mm Dia. x 14.0mm (L)
7.20mm Dia. x 7.0mm (L)7.20mm Dia. x 8.0mm (L)7.20mm Dia. x 10.0mm (L)7.20mm Dia. x 12.0mm (L)	5.28mm Dia. x 8.0mm(L)5.28mm Dia. x 10.0mm(L)5.28mm Dia. x 12.0mm(L)5.28mm Dia. x 14.0mm(L)	6.0mm Dia. x 7.0mm (L)6.0mm Dia. x 8.0mm (L)6.0mm Dia. x 10.0mm (L)6.0mm Dia. x 12.0mm (L)
	6.28mm Dia. x 8.0mm(L)6.28mm Dia. x 10.0mm(L)6.28mm Dia. x 12.0mm(L)6.28mm Dia. x 14.0mm(L)	7.0mm Dia. x 7.0mm (L)7.0mm Dia. x 8.0mm (L)7.0mm Dia. x 10.0mm (L)7.0mm Dia. x 12.0mm (L)

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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.

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.