(252 days)
No
The 510(k) summary describes a dental implant made of titanium alloy with a specific surface treatment. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven decision-making process. The performance studies focus on material properties, sterilization, shelf-life, and biocompatibility, which are standard for this type of device.
Yes
The device is intended to treat missing teeth and restore chewing function by supporting prosthetic devices, which aligns with the definition of a therapeutic device.
No
The device is described as an implantable medical device (dental implant) intended to restore chewing function by supporting prosthetic devices. Its purpose is therapeutic and restorative, not diagnostic.
No
The device description clearly states the device is made of Titanium Alloy and is surgically implanted, indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- S-Mono Function: The S-Mono is a dental implant. It is surgically implanted into the patient's jawbone to support a prosthetic tooth. Its function is to restore chewing function, not to diagnose a condition or provide information about a patient's health through testing of bodily samples.
The description clearly outlines a surgically implanted device used for structural support, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular central and lateral incisors (alveolar bone of the mandibular anterior region)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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) |
|---|
| ------------------------------------------------- |
| 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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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.