The Luna Dental Implant System 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, and to restore the patient s chewing function

Device Description

The Luna Dental Implant System is a device of pure titanium(ASTM F67) and titanium alloy(ASTM F136) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw. The fixture's surface is S.L.A(Sand-Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System fixture and healing abutment are supplied with gamma sterilization.

Fixtures consisted of mount type and mount free type. Abutments consisted of simple abutment, hex and non-hex duo abutment, hex and non-hex angled abutment (15° & 25°), hex and non-hex contour abutment, hex and non-hex temporary abutment screw abutment with titanium cylinder, ball abutment with socket assembly, healing abutment, screw abutment screw, and abutment screw. Fixture dimension is 3.7mm x 8.5-15mm and 4.2mm - 5.7mm x 7.0mm - 15mm and Abutment diameter is 4.0mm ~ 6.0mm

AI/ML Overview

The Luna Dental Implant System, an endosseous dental implant, established substantial equivalence by comparing its performance to predicate devices (Dentium Implantium K041368 and Implantium Prosthetics K052957). The device, made of pure titanium and titanium alloy, is designed for surgical placement in the jaw to support prosthetic devices and restore chewing function.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance testing conducted to demonstrate compliance with ISO standards and confirm performance characteristics. The specific quantitative acceptance criteria or thresholds for these tests are not explicitly stated. Instead, the document generally asserts that the device met the established specifications necessary for consistent performance.

Test Category	Specific Test	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance
Biocompatibility	ISO Cytotoxicity	(Implicit: Non-toxic)	Materials are non-toxic to biological tissues.
	ISO Systemic toxicity	(Implicit: Non-toxic)	Materials are non-toxic to biological tissues.
	ISO Pyrogenicity	(Implicit: Non-pyrogenic)	Materials are non-pyrogenic.
	ISO Sensitization	(Implicit: Non-sensitizing)	Materials are non-sensitizing to biological tissues.
	ISO Intracutaneous reactivity	(Implicit: Non-reactive)	Materials are non-reactive.
	ISO Implantation	(Implicit: Biocompatible)	Materials are consistent with intended use.
Mechanical/Physical	ISO Static compressive	(Implicit: Meets specified strength/load limits)	Confirmed performance characteristics.
	ISO Fatigue	(Implicit: Meets specified fatigue life)	Confirmed performance characteristics.
	Torque Force	(Implicit: Meets specified torque requirements)	Confirmed performance characteristics.
	Adaptation Accuracy	(Implicit: Meets specified fit/accuracy)	Confirmed performance characteristics.
	Rotational shear strength	(Implicit: Meets specified shear strength)	Confirmed performance characteristics.
	Loosening torque	(Implicit: Meets specified loosening resistance)	Confirmed performance characteristics.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample sizes used for any of the performance tests (biocompatibility or mechanical/physical). It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective). However, the submission is from a South Korean company (SHINHUNG MST Co., Ltd in the Republic of Korea), suggesting that the testing and data likely originated in South Korea. The nature of the tests (bench testing and biocompatibility) suggests they are laboratory-based and controlled studies, rather than clinical trials with human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This section is not applicable to the provided document. The performance tests described (biocompatibility, mechanical bench testing) do not involve expert interpretation or subjective assessment of a test set in a clinical context to establish 'ground truth' in the way a diagnostic AI device would. The "ground truth" for these tests would be objective measurements against established engineering and biological standards.

4. Adjudication Method for the Test Set:

This section is not applicable as the testing described does not involve methods requiring expert adjudication for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. The Luna Dental Implant System is a physical medical device, not a diagnostic AI tool, so this type of study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This section is not applicable. The Luna Dental Implant System is a physical dental implant, not an algorithm or AI system. Its performance is evaluated through bench testing and biocompatibility assessments, not through algorithmic performance.

7. The Type of Ground Truth Used:

The ground truth for the Luna Dental Implant System's performance testing is based on:

Established ISO Standards: For biocompatibility (ISO 7405) and presumably for mechanical/physical properties, the 'ground truth' refers to compliance with the specific criteria and methodologies outlined in these international standards.
Material Specifications: The chemical composition and physical properties of titanium and titanium alloy (ASTM F67 and ASTM F136) are known and serve as a baseline for material quality.
Engineering Specifications: For mechanical tests, the 'ground truth' is determined by meeting predefined engineering specifications for strength, fatigue, torque, accuracy, etc., which are derived from industry standards and clinical requirements for dental implants.

8. The Sample Size for the Training Set:

This section is not applicable. The Luna Dental Implant System is a physical device being evaluated through performance testing, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This section is not applicable as there is no training set for a physical medical device like the Luna Dental Implant System.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Submitted by :

Oct /31/2013

Sunbyung, Lee / Manager / Quality assurance team SHINHUNG MST Co., Ltd 1642-8, Donghwa-Ri, Munmak-Eup, Wonju-Si, Gangwon-Do, 220-878, South Korea Phone : +82-33-730-1900 Fax : +82-33-730-1919

2. Device Name :

Trade Name	:	Luna Dental Implant System
Common Names	:	Endosseous Dental Implant
Classification Name	:	Implant, Endosseous, Root-Form

3. Predicate Device :

3.1 Dentium Implantium (K041368) Manufactured by Dentium Co., Ltd 3.2 Implantium Prosthetics(K052957) Manufactured by Dentium Co., Ltd

OCT 3 1 2013

4. Device Description :

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assembly, healing abutment, screw abutment screw, and abutment screw. Fixture dimension is 3.7mm x 8.5-15mm and 4.2mm - 5.7mm x 7.0mm - 15mm and Abutment diameter is 4.0mm ~ 6.0mm

5. Intended For Use :

6. Substantial Equivalence :

Device Name	Subject Device	Predicate Device
Manufacturer	SHINHUNG MST Co., Ltd	Dentium Co., Ltd	Dentium Co., Ltd
510(k) Number	New	K041368	K052957
Materials	Titanium, Titanium Alloy	Titanium, Titanium Alloy	Titanium, Titanium alloy, Gold alloy
Form	Implant, Endosseous, Root-Form	Implant, Endosseous, Root-Form	Abutment, Dental,Endosseous, implants
Indications foruse	The Luna Dental ImplantSystem is intended to besurgically placed in the boneof the upper or lower jawarches to provide supportfor prosthetic devices, suchas artificial teeth, and torestore the patient's chewingfunction	The Dentium Co., LtdImplantium is intended to besurgically placed in the boneof the upper or lower jawarches to provide supportfor prosthetic devices, suchas artificial teeth, and torestore the patient's chewingfunction	Intended for use as an aid inprosthetic rehabilitation.
Use	Prescription	Prescription	Prescription
Sterilization	It is supplied sterile(Gammaradiation)	It is supplied sterile(Gammaradiation)	It is supplied Non-sterile

The comparison between Luna Dental Implant System and other predicated devices is claimed to be substantially equivalence in terms of indication for use, materials, product form, technology, and performance specifications.

The difference between Luna Dental Implant System and predicate devices are the product shape and slight mechanical and physical characteristics. However, the slight differences do not affect to the application of the device. Therefore, we state that Luna Dental Implant System is substantially equivalent to the predicate devices

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SHINHUNG MST

7. Performance Testing

Biocompatibility testing on the proposed Luna Dental Implant System has been completed. Requirements for biological evaluation of the proposed device were based on the ISO7405(2008), "Dentistry-Evaluation of biocompatibility of medical devices used in dentistry." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed

-ISO Cytotoxicity	-ISO Systemic toxicity
-ISO Pyrogenicity	-ISO Sensitization
-ISO Intracutaneous reactivity	-ISO Implantation

The proposed -ISO Sensitization was evaluated using the following performance bench testing to confirm the performance characteristics:

-ISO Static compressive	-ISO Fatigue
-Torque Force	-Adaptation Accuracy
-Rotational shear strength	-Loosening torque

8. Review

All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Luna Dental Implant System met the established specifications necessary for consistent performance according to its intended use.

Luna Dental Implant System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

9. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification SHINHUNG MST Co., Ltd concludes that the Luna Dental Implant System is substantially equivalent to the predicate devices as described herein.

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

October 31, 2013

SHINHUNG MST Company, Limited Sunbyung Lee Team Leader 1642-8, Donghwa-Ri, Munmak-Eup Wonju-Si. Gangwon-Do 220-878 REPUBLIC OF KOREA

Re: K123155

Trade/Device Name: Luna Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE, NHA Dated: August 26, 2013 Received: August 30, 2013

Dear Mr. Lee:

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 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

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Page 2 - Mr. Lee

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

MarySTBuner-S

Kwame Ulmer M.S. Acting Division 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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Indication for use Statement

K123155 510(k) Number ( If known ) :

Device Name : Luna Dental Implant System

Indication for use :

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter _ (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Indication for use statement

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.