The S-Mono is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is intended for delayed loading.

Device Description

The S-Mono is made of Titanium Alloy (ASTM F136) as the raw material. This device supports dental prosthesis such as an artificial tooth by surgically implanting it in the alveolar bone of the mandibular anterior region with a narrow tooth gap, and is intended to restore the patient's chewing function. It is one-body type which includes fixture and abutment. The surface of the fixture is treated using RBM (Resorbable Blast Media). It is roughened by blasting with hydroxyapatite powder and then pickling with nitric acid. The Temporary Cap is made of POM (Polyoxy Methylene) and intended to relieve the patient's foreign body sensation and protect the abutment part while the dental prosthesis is being manufactured. This cap is placed over the abutment part and is used temporarily before the dental prosthesis is placed. The material, dimension, and intended use of the subject devices are similar to devices currently marketed worldwide.

AI/ML Overview

This document describes a 510(k) premarket notification for a dental implant system called S-Mono. The provided text, however, does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or performance study involving human subjects or AI algorithm performance metrics.

The document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of proving the device meets certain performance metrics through standalone testing, the manufacturer compares the new device (S-Mono) to existing, legally marketed devices (predicates) and argues that it is as safe and effective because of similar intended use, materials, and technological characteristics.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details because this information is not present in the provided text.

The "Non-Clinical Testing" section describes several tests performed on the S-Mono, but these are primarily material, sterilization, shelf-life, and biocompatibility tests, not performance studies that would typically define "acceptance criteria" through clinical outcomes or diagnostic accuracy.

Non-Clinical Testing Information Provided:

Sterilization validation testing: Performed according to ISO 11137 (gamma sterilization) and ISO 11737, ISO 17665-1, ISO 17665-2 (steam sterilization).
Shelf-life testing: Performed according to ASTM F1980, ASTM F1929, and ISO 11737-2.
Fixture surface characteristics evaluation: EDS (Energy-dispersive X-ray spectroscopy), SEM Analysis, and Surface Roughness Analysis were performed after RBM treatment.
Biocompatibility tests: Performed according to ISO 10993-1, 3, 5, 6, 10, 11, 12, and 33.
MR Conditional labeling: A non-clinical worst-case MRI review was conducted using scientific evidence and published literature (Woods, Terry O., et al., 2019). Titanium alloy (Ti-6A1-4V, ELI) properties were assessed according to magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119).

In summary, the provided text describes the regulatory filing for a dental implant and focuses on demonstrating substantial equivalence, not on providing the results of a performance study with acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K221317

Trade/Device Name: S-Mono Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 13, 2022 Received: December 15, 2022

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 -S

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) K221317

Device Name S-Mono

Indications for Use (Describe)

The S-Mono is intended to use in the treatment of missing mandibular central incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is intended for delayed loading.

Type of Use (Select one or both, as applicable)
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Remediation Use (Per 21 CFR 201.321 Subpart D)
Over-The-Counter Use (21 CFR 201.66)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (K221317)

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

Date: 1/12/2023

1. Submitter

SHINHUNG MST CO., LTD. 110-2, Donghwagondan-ro, Munmak-eup, Wonju-si, Gangwon-do, Republic of Korea, 26365

Tel: +82-33-730-1901

2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman STE 160, Irvine CA 92612 Fax: 714-409-3357 Phone: 714-202-5789 Email: juhee.c@lkconsultinggroup.com

3. Device

Trade Name: S-Mono
Common Name: Dental Implant System ●
Classification Name: Endosseous Dental Implant ●
Product Code: DZE, NHA
Classification regulation: 21CFR 872.3640

4. Predicate Device:

. Primary Predicate: MS SYSTEM by OSSTEM Implant Co., Ltd. (K083067)
. Reference Devices: MS SA IMPLANT SYSTEM by OSSTEM Implant Co., Ltd. (K122171) MS System (Narrow Ridge) by OSSTEM Implant Co., Ltd. (K080594)

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5. Description:

6. Indication for use:

7. Basis for Substantial Equivalence

Device Name	Subject Device	Primary PredicateDevice	Reference PredicateDevice
Manufacturer	SHINHUNG MST CO.,LTD.	OSSTEM Implant Co.,Ltd.	OSSTEM Implant Co., Ltd.
Device Name	S-Mono	MS System(Narrow Ridge)	MS SA IMPLANTSYSTEM(Narrow Ridge)
510(k) Number	K221317	K083067	K122171
Design	Image: S-Mono Design	Image: MS System (Narrow Ridge) Design	Image: MS SA IMPLANT SYSTEM (Narrow Ridge) Design
Intended use	The S-Mono is intended touse in the treatment ofmissing mandibular centraland lateral incisors tosupport prosthetic device,such as artificial teeth, inorder to restore chewingfunction in partiallyedentulous patients. S-Mono is intended for singleuse only. It is intended for	The MS System(Narrow Ridge) isintended to use in thetreatment of missingmandibular central andlateral incisors tosupport prostheticdevice, such asartificial teeth, in orderto restore chewingfunction in partially	The MS SA System(Narrow Ridge) is intendedto use in the treatment ofmissing mandibular centraland lateral incisors tosupport prosthetic device,such as artificial teeth, inorder to restore chewingfunction in partiallyedentulous patients. MS SASystem (Narrow Ridge) is

Dental Implant System

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	delayed loading.	edentulous patients.MS System(Narrow Ridge) isintended for single useonly. It is not forimmediate loading.	intended for single use only.It is intended for delayedloading.
Structure	- R.B.M (ResorbableBlasting Media).- Threaded Body Design- One Body Implant	- R.B.M (ResorbableBlasting Media).- Threaded BodyDesign- One Body Implant	- SA (Sandblasting and acidetching).- Threaded Body Design- One Body Implant
Thread bodyDiameter (D)	2.5, 3.0	2.5, 3.0	2.5, 2.9
Length (mm) ofthread	8.5, 10.0, 11.5, 13.0	10.0, 11.5, 13.0	8.5, 10.0, 11.5, 13.0
Material	Titanium alloy Ti-6Al-4V(ASTM F136)	Titanium alloy Ti-6Al-4V(ASTM F136)	Titanium alloy Ti-6Al-4V(ASTM F136)
Surface	R.B.M (Resorbable BlastingMedia)	R.B.M (ResorbableBlasting Media)	SA (Sandblasting and acidetching)
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile
S.E.	The S-Mono has the same intended use, material, and technological characteristics asthe predicate device. There is a difference in wording between the subject device andthe primary predicate device which is "It is not for immediate loading" vs "It isintended for delayed loading". However, the revision in wording does not change thedevice indications.There might be some other differences in design, however, the differences are minorand do not raise a question in safety and performance for its intended use. Based onthe information provided in this submission, we conclude that the subject device issubstantially equivalent to the predicate device.

Temporary Cap

Device Name	Subject Device	Predicate Device
Manufacturer	SHINHUNG MST CO., LTD.	OSSTEM Implant Co., Ltd.
Device Name	S-Mono	MS System(Narrow Ridge)
Design	Image: S-Mono design	Image: MS System (Narrow Ridge) design
510(k) Number	K221317	K080594
Intended use	The S-Mono is intended to use in thetreatment of missing mandibular centraland lateral incisors to support prostheticdevice, such as artificial teeth, in orderto restore chewing function in partiallyedentulous patients. S-Mono is intendedfor single use only. It is not forimmediate loading.	The MS System (Narrow Ridge) isintended to use in the treatment ofmissing mandibular central and lateralincisors to support prosthetic device,such as artificial teeth, in order torestore chewing function in partiallyedentulous patients. MS System(Narrow Ridge) are intended for singleuse only and not for immediate loading.

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Structure	One-touch locking design	One-touch locking design
Material	POM (Polyoxy Methylene)ASTM 1855	POM (Polyoxy Methylene)ASTM 1855
Sterilization	User sterile	User sterile
S.E.	The S-Mono has the same intended use, material, and technological characteristicsas the predicate device. There might be some differences in design, however, thedifferences are minor and do not raise a question in safety and performance for itsintended use. Based on the information provided in this submission, we concludethat the subject device is substantially equivalent to the predicate device.

8. Non-Clinical Testing

. Sterilization validating testing has been performed in accordance with ISO 11137 for gamma sterilization and ISO 11737, ISO 17665-1, and ISO 17665-2 for steam sterilization.
. Shelf-life testing has been performed in according with ASTM F1980, ASTM F1929, and ISO 11737-2.
EDS (Energy-dispersive X-ray spectroscopy), SEM Analysis, and Surface Roughness ● Analysis were performed to evaluate the fixture surface characteristics after RBM treatment.
Biocompatibility Tests were performed in accordance with ISO 10993-1, 3, 5, 6, 10, ● 11, 12, and 33.
. MR Conditional labeling

A non-clinical worst-case MRI review was conducted to evaluate the S-Mono Implant System device in an MRI environment using scientific evidence and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795). Titanium alloy (Ti-6A1-4V, ELI) was assessed according to magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119) by T. O. Woods et al. Based on that rationale, we have addressed parameters per FDA guidance " Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetic induced displacement force and torque.

9. Conclusion

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

Overall, the S-Mono 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

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Based on the similarities, we conclude that the S-Mono 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.