Who is the manufacturer of S-Mono?

Shinhung Mst Co., Ltd. filed the 510(k) submission for S-Mono (K221317).

What is the FDA product code for S-Mono?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for S-Mono?

510(k) clearance (submission type: Traditional).

What are the predicate devices for S-Mono?

MS SYSTEM by OSSTEM Implant Co., Ltd. (K083067); MS System (Narrow Ridge) by OSSTEM Implant Co., Ltd. (K080594).

Who can help prepare an FDA 510(k) submission like S-Mono?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

S-Mono

K221317 · Shinhung Mst Co., Ltd. · DZE · Jan 13, 2023 · Dental

Device Facts

Record ID	K221317
Device Name	S-Mono
Applicant	Shinhung Mst Co., Ltd.
Product Code	DZE · Dental
Decision Date	Jan 13, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

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 Story

S-Mono is a one-body endosseous dental implant system comprising a fixture and abutment; manufactured from titanium alloy (ASTM F136). Fixture surface treated via Resorbable Blast Media (RBM) process (hydroxyapatite blasting, nitric acid pickling). Includes a POM (Polyoxy Methylene) temporary cap to protect the abutment and reduce foreign body sensation during prosthesis fabrication. Used by dental clinicians in clinical settings; surgically implanted into the mandibular anterior alveolar bone. Device supports artificial teeth to restore chewing function. Clinical benefit includes restoration of masticatory function in patients with narrow tooth gaps. Output is a stable foundation for dental prosthetics. Device is MR conditional.

Clinical Evidence

Bench testing only. Evidence includes sterilization validation (ISO 11137, ISO 17665), shelf-life testing (ASTM F1980, F1929), surface characterization (EDS, SEM, roughness analysis), and biocompatibility (ISO 10993 series). MRI safety evaluated via scientific literature and rationale per FDA guidance for magnetic displacement, torque, RF heating, and image artifacts.

Technological Characteristics

One-body dental implant; Titanium alloy (ASTM F136); RBM surface treatment (hydroxyapatite/nitric acid). Temporary cap: POM (ASTM 1855). Threaded body design; diameters 2.5/3.0mm; lengths 8.5-13.0mm. Sterilization: Radiation (fixture), User sterile (cap). MR Conditional.

Indications for Use

Indicated for partially edentulous patients with missing mandibular central and lateral incisors requiring prosthetic support to restore chewing function. Intended for delayed loading; single use only.

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

MS SYSTEM by OSSTEM Implant Co., Ltd. (K083067)
MS System (Narrow Ridge) by OSSTEM Implant Co., Ltd. (K080594)

Reference Devices

MS SA IMPLANT SYSTEM by OSSTEM Implant Co., Ltd. (K122171)

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {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 (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 {2}------------------------------------------------ ## 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) | |-------------------------------------------------| |-------------------------------------------------| | <div style="display:flex; align-items:center;"> <svg class="bi bi-check" fill="currentColor" height="1em" style="margin-right: 5px;" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M13.854 3.646a.5.5 0 0 1 0 .708l-7 7a.5.5 0 0 1-.708 0l-3-3a.5.5 0 0 1 .708-.708L6.5 10.293l6.646-6.647a.5.5 0 0 1 .708 0z" fill-rule="evenodd"></path> </svg> Remediation Use (Per 21 CFR 201.321 Subpart D) </div> | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"> <svg class="bi bi-square" fill="currentColor" height="1em" style="margin-right: 5px;" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 201.66) </div> | > Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) #### 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 (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) {4}------------------------------------------------ #### 5. 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. #### 6. Indication for use: 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. #### 7. Basis for Substantial Equivalence | Device Name | Subject Device | Primary Predicate Device | Reference Predicate Device | |---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | SHINHUNG MST CO., LTD. | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. | | Device Name | S-Mono | MS System (Narrow Ridge) | MS SA IMPLANT SYSTEM (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 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 | The MS System (Narrow Ridge) 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 | The MS SA System (Narrow Ridge) 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. MS SA System (Narrow Ridge) is | - Dental Implant System {5}------------------------------------------------ | | delayed loading. | edentulous patients. MS System (Narrow Ridge) is intended for single use only. It is not for immediate loading. | intended for single use only. It is intended for delayed loading. | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Structure | - R.B.M (Resorbable Blasting Media). - Threaded Body Design - One Body Implant | - R.B.M (Resorbable Blasting Media). - Threaded Body Design - One Body Implant | - SA (Sandblasting and acid etching). - Threaded Body Design - One Body Implant | | Thread body Diameter (D) | 2.5, 3.0 | 2.5, 3.0 | 2.5, 2.9 | | Length (mm) of thread | 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 Blasting Media) | R.B.M (Resorbable Blasting Media) | SA (Sandblasting and acid etching) | | Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | | S.E. | The S-Mono has the same intended use, material, and technological characteristics as the predicate device. There is a difference in wording between the subject device and the primary predicate device which is "It is not for immediate loading" vs "It is intended for delayed loading". However, the revision in wording does not change the device indications. There might be some other differences in design, however, the differences are minor and do not raise a question in safety and performance for its intended use. Based on the information provided in this submission, we conclude that the subject device is substantially 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 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 not for immediate loading. | The MS System (Narrow Ridge) 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. MS System (Narrow Ridge) are intended for single use only and not for immediate loading. | {6}------------------------------------------------ | 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 characteristics as the predicate device. There might be some differences in design, however, the differences are minor and do not raise a question in safety and performance for its intended use. Based on the information provided in this submission, we conclude that 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 {7}------------------------------------------------ Based on the similarities, we conclude that the S-Mono is substantially equivalent to the predicate devices.

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