Stella

K221752 · Shinhung Mst Co., Ltd. · DZE · Jun 4, 2023 · Dental

Device Facts

• Record ID: K221752
• Device Name: Stella
• Applicant: Shinhung Mst Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jun 4, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.

Device Story

Stella is a dental implant system consisting of a titanium fixture and various abutments (healing, simple, duo, contour, angled, temporary) and screws. The fixture is surgically implanted into the jawbone to support prosthetic restorations. It features a tissue-level, self-tapping design with an internal octagonal connection. The device is used by dental surgeons in clinical settings. The fixture is surface-treated via alumina blasting and pickling to enhance osseointegration. The system restores chewing function for patients with tooth loss. Clinical decision-making is supported by the implant's ability to provide stable anchorage for prosthetics, with options for delayed or immediate loading based on primary stability. Benefits include restoration of masticatory function and dental aesthetics.

Clinical Evidence

Bench testing only. Evidence includes fatigue testing per ISO 14801, biocompatibility, shelf-life, sterilization validation (gamma radiation/moist heat), and packaging integrity. MRI safety was evaluated via scientific literature and established standards (ASTM F2052, F2213, F2182, F2119) to assess displacement, torque, heating, and artifacts.

Technological Characteristics

Materials: Pure Titanium Grade 4 (ASTM F67) and Titanium Alloy Ti-6Al-4V (ASTM F136). Design: Tissue-level, self-tapping, internal octagonal connection, tapered body. Surface: SLA (Al2O3 blasted and pickled). Sterilization: Gamma radiation (fixtures/screws) or user-sterilized (abutments). Connectivity: Mechanical dental implant system.

Indications for Use

Indicated for patients with partial or total tooth loss requiring dental implants in the upper or lower jawbone to support prosthetic restorations (artificial teeth, overdentures, or partial dentures).

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

• SSII/III SA Fixture by OSSTEM Implant Co., Ltd. (K120847)
• Luna Dental Implant System by SHINHUNG MST CO., LTD. (K123155)
• Luna Dental Implant System by SHINHUNG MST CO., LTD. (K160106)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

#### SHINHUNG MST CO., LTD.

% Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. Suite 160 Irvine, California 92612

Re: K221752

Trade/Device Name: Stella Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 28, 2023 Received: March 6, 2023

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 ([e-mail]) or phone [phone] 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) K221752

Device Name Stella

#### Indications for Use (Describe)

The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading.

The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|--|
| <span style="font-size:12pt;">☑</span> 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 (K221752)

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

Date: 6/02/2023

### 1. Submitter

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

Tel: [phone]

## 2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman STE 160, Irvine CA 92612 Fax: [phone] Phone: [phone] Email: [e-mail]

### 3. Device

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

### 4. Predicate Device:

SSII/III SA Fixture by OSSTEM Implant Co., Ltd. (K120847) Luna Dental Implant System by SHINHUNG MST CO., LTD. (K123155 / K160106)

## 5. Description:

Stella is a dental implant fixture that is implanted in the jawbone to support and maintain prosthetic restoration teeth or dentures in case of partial or total loss of teeth as a material for dental surgery. The fixture is made of titanium (ASTM F67, Grade 4), and the retention area is surface treated by spraying with Al2O3 (alumina) powder and then

{4}------------------------------------------------

pickling to roughen the surface.

The system incudes Healing Abutment, Simple Abutment, Duo Abutment, Contour Abutment, Angled Abutment, and Temporary Abutment.

#### 6. Indication for use:

The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.

### 7. Basis for Substantial Equivalence

### Comparison Chart

| Device Name | Subject Device | Predicate Device | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SHINHUNG MST CO.,<br>LTD. | Osstem Implant Co., Ltd.<br>SHINHUNG MST CO.,<br>LTD. | |
| Device Name | Stella | SSII/III SA Fixture<br>Luna Dental Implant<br>System | |
| Design | Image: Stella Implant | Image: SSII/III SA Fixture | Image: Luna Dental Implant System |
| 510(k) Number | K221752 | K120847 | K123155 / K160106 |
| Intended use | The Stella is intended to be<br>surgically placed in the<br>upper or lower jawbone to<br>provide support for<br>prosthetic devices, such as<br>artificial teeth, restoring<br>the patient's chewing<br>capabilities. The Stella is<br>intended for delayed<br>loading and immediate<br>loading is possible when<br>good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading.<br>The Stella Abutment is<br>intended to be connected<br>to the dental implant to<br>retain the overdenture or | ET/SS Implant System is<br>indicated for use in<br>partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple-unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is intended<br>for delayed loading. The<br>abutment is intended for<br>use with a dental implant<br>fixture to provide support<br>for prosthetic restorations<br>such as crowns, bridges, or | The Luna Dental Implant<br>System is intended to be<br>surgically placed in the<br>bone of the upper or lower<br>jaw arches to provide<br>support for prosthetic<br>devices, such as artificial<br>teeth, and to restore the<br>patient's chewing function. |
| | partial denture. | overdenture. | |
| Structure | - Tissue level fixture<br>- Self tapping<br>- Internal Octagonal<br>connection<br>- Taper body shape | - Tissue level fixture<br>- Self tapping<br>- Internal Octagonal<br>connection<br>- Straight / Taper body<br>shape | - Bone level fixture<br>- Self tapping<br>- Internal Hexagonal<br>connection<br>- Taper body shape |
| Platform<br>Diameter<br>(D) (mm) | 4.8, 6.0 | 4.8, 6.0 | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0,<br>7.0 |
| Body Diameter<br>(D) (mm) | 3.7, 4.2, 4.7, 5.2 | 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.7, 4.2, 4.7, 5.2, 5.7, 6.0,<br>7.0 |
| Length (mm) | 7.0, 8.5, 10.0, 11.5, 13.0,<br>15.0<br>*The following size<br>configurations are not<br>included.<br>· 4.8mm platform diameter<br>x 3.7mm body diameter x<br>7.0mm length.<br>· 4.8mm platform diameter<br>x 5.2mm body diameter x<br>all length.<br>· 6.0mm platform diameter<br>x 3.7 mm body diameter x<br>all length.<br>· 6.0mm platform diameter<br>x 4.2 mm body diameter x<br>all length. | 6.0, 7.0, 8.5, 10.0, 11.5,<br>13.0<br>*The following size<br>configurations are not<br>included.<br>· 4.8mm platform diameter<br>x 3.5mm body diameter x<br>7.0mm length.<br>· 4.8mm platform diameter<br>x all body diameter x<br>6.0mm length.<br>· 4.8mm platform diameter<br>x 5.0mm body diameter x<br>all length.<br>· 4.8mm platform diameter<br>x 6.0mm body diameter x<br>all length.<br>· 4.8mm platform diameter<br>x 7.0mm body diameter x<br>all length.<br>· 6.0mm platform diameter<br>x 3.5mm body diameter x<br>all length.<br>· 6.0mm platform diameter<br>x 4.0mm body diameter x<br>all length.<br>· 6.0mm platform diameter<br>x 4.5mm body diameter x<br>6.0mm length. | 7.0, 8.5, 10.0, 11.5, 13.0,<br>15.0<br>*The following size<br>configurations are not<br>included.<br>· 3.7mm body diameter x<br>7.0mm length.<br>· 5.7mm body diameter x<br>15.0mm length.<br>· 6.0mm body diameter x<br>15.0mm length.<br>· 7.0mm body diameter x<br>15.0mm length. |
| Material | Pure Titanium Gr 4<br>(ASTM F67) | Pure Titanium Gr 4<br>(ASTM F67) | Pure Titanium Gr 4<br>(ASTM F67) |
| Surface | S.L.A. | S.L.A. | S.L.A. |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |

- Dental fixture

{5}------------------------------------------------

{6}------------------------------------------------

| | This product has the same intended use as the predicate device, and its main purpose is to restore the masticatory function by implanting it in the toothless areas of the upper and lower jaws. It is a non-submerged fixture identical to Osstem's SSII/III SA Fixture (K120847), and there is a groove for self-tapping at the end of the body. The diameter of the platform is the same as that of the Osstem. The diameter of the body is similar to that of the Osstem, and the safety of the 3.7mm diameter has been proven in the Luna Dental Implant System. In addition, it was confirmed that there was no strength problem through the fatigue test on the fixture diameter 3.7mm. The length of the product is within the range of the length of the Osstem product. The connection to the abutment is also made of an internal octagonal structure. The raw material was made of Pure Titanium Grade 4 (ASTM F67) in the same way as the predicate device, and the surface treatment was SA-treated. It is manufactured through the same raw materials and manufacturing process as our previously licensed Luna Dental Implant Systems (K123155 / K160106). Sterilization is also provided through gamma sterilization. |
|------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| S.E. | |

# ▪ Abutment

| Device Name | Subject Device | Predicate Device | |
|------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SHINHUNG MST CO.,<br>LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO.,<br>LTD. |
| Device Name | Healing Abutment | Healing Abutment | Healing Abutment |
| Design | Image: Healing Abutment | Image: Healing Abutment | Image: Healing Abutment |
| 510(k) Number | K221752 | K120847 | K123155 |
| Diameter (mm) | 4.8, 6.0 | 4.8, 6.0 | 4.0, 4.5, 5.0, 6.0 |
| Gingiva Height<br>(mm) | 2.0, 3.0, 4.0 | 2.0, 3.0, 4.0, 5.0<br>*The following size<br>configurations are not<br>included.<br>. 6.0mm diameter x 2.0mm<br>Gingiva height. | 2.0, 3.0, 4.0, 5.0, 6.0<br>*The following size<br>configurations are not<br>included.<br>. 6.0mm diameter x 6.0mm<br>Gingiva height. |
| Material | Pure Titanium Gr 4 | Titanium Alloy Ti-6Al-4V | Pure Titanium Gr 4 |

{7}------------------------------------------------

| | (ASTM F67) | (ASTM F136) | (ASTM F67) |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------|
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| S.E. | Healing Abutment is a product that is used temporarily before installing a permanent<br>superstructure. This product has the same purpose as the predicate device and has a<br>size within the product size range of Osstem. Unlike Osstem's, the raw material was<br>manufactured with Pure Titanium Grade 4 (ASTM F67), and was manufactured with<br>the same material as our previously approved product, Luna Dental Implant System<br>(K123155). It is gamma-sterilized and provided to the user. | | |

| Device Name | Subject Device | Predicate Device | |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------|
| Manufacturer | SHINHUNG MST CO.,<br>LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO.,<br>LTD. |
| Device Name | Simple Abutment | Solid Abutment | Simple Abutment |
| Design | Image: Simple Abutment | Image: Solid Abutment | Image: Simple Abutment |
| 510(k) Number | K221752 | K120847 | K123155 |
| Diameter (mm) | 4.8, 6.0 | 4.8, 6.0 | 4.1, 4.6, 5.1, 6.1 |
| Post Height<br>(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 |
| Material | Titanium Alloy Ti-6Al-4V<br>(ASTM F136) | Titanium Alloy Ti-6Al-4V<br>(ASTM F136) | Titanium Alloy Ti-6Al-4V<br>(ASTM F136) |
| Sterilization | User sterile | User sterile | User sterile |
| S.E. | Simple abutments can be used in both anterior and posterior areas of the mouth for<br>cement retained crown and bridge restorations. This product has the same purpose as<br>the predicate device and has a size within the product size range of Osstem. The raw<br>material is the same as the predicate device. In addition, it is manufactured through the<br>same manufacturing process as our Luna Dental Implant System. Our previously<br>approved product, Luna Dental Implant System (k123155), uses the same raw<br>materials as the applied product, but only a part of it is coated with TiN. However, the<br>whole is not coated with TiN, and it can be seen that the portion with TiN coating is<br>the worst case in terms of biocompatibility. Thus, the safety of the raw material is<br>demonstrated. This product is sterilized by the user by the method described in the<br>user manual. | | |

| Device Name | Subject Device | Predicate Device | |
|--------------|---------------------------|--------------------------|---------------------------|
| Manufacturer | SHINHUNG MST CO.,<br>LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO.,<br>LTD. |
| Device Name | Duo Abutment | ComOcta Abutment | Duo Abutment |

{8}------------------------------------------------

| Design | Image: Abutment design | Image: Abutment design | Image: Abutment design |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|----------------------------------|
| 510(k) Number | K221752 | K120847 | K123155 |
| Diameter (mm) | 4.8, 6.0 | 4.8, 6.0 | 4.6, 5.1, 6.1 |
| Post Height<br>(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 |
| Material | Pure Titanium Gr 4<br>(ASTM F67) | Titanium Alloy Ti-6Al-4V<br>(ASTM F136) | Pure Titanium Gr 4<br>(ASTM F67) |
| Sterilization | User sterile | User sterile | User sterile |
| S.E. | Duo abutment can be used in both anterior and posterior areas of the mouth for cement<br>retained crown and bridge restorations. This product has the same purpose as the<br>predicate device and has a size within the product size range of Osstem. The raw<br>material is the same as the predicate device. In addition, it is manufactured through the<br>same manufacturing process as our Luna Dental Implant System. Our previously<br>approved product, Luna Dental Implant System (k123155), uses the same raw<br>materials as the applied product, but only a part of it is coated with TiN. However, the<br>whole is not coated with TiN, and it can be seen that the portion with TiN coating is<br>the worst case in terms of biocompatibility. Thus, the safety of the raw material is<br>demonstrated. This product is sterilized by the user by the method described in the<br>user manual. | | |

| Device Name | Subject Device | Predicate Device | Predicate Device | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|----------------------------------|--|
| Manufacturer | SHINHUNG MST CO.,<br>LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO.,<br>LTD. | |
| Device Name | Contour Abutment | ComOcta Milling<br>Abutment | Contour Abutment | |
| Design | Image: Contour Abutment | Image: ComOcta Milling Abutment | Image: Contour Abutment | |
| 510(k) Number | K221752 | K120847 | K123155 | |
| Diameter (mm) | 5.5, 6.7 | 4.8, 6.0 | 4.1, 5.6 | |
| Gingiva Height<br>(mm) | 2.0, 4.0 | 2.0 | 1.5, 3.0 | |
| Material | Pure Titanium Gr 4<br>(ASTM F67) | Titanium Alloy Ti-6Al-4V<br>(ASTM F136) | Pure Titanium Gr 4<br>(ASTM F67) | |
| Sterilization | User sterile | User sterile | User sterile | |
| S.E. | This product has the same purpose as the predicate device and has a size within the<br>product size range of Osstem. The raw material is the same as the predicate device<br>(K123155). In addition, it is manufactured through the same manufacturing process as<br>our Luna Dental Implant System. Our previously approved product, Luna Dental<br>Implant System (k123155), uses the same raw materials as the applied product, but<br>only a part of it is coated with TiN. However, the whole is not coated with TiN, and it | | | |

{9}------------------------------------------------

can be seen that the portion with TiN coating is the worst case in terms of biocompatibility. Thus, the safety of the raw material is demonstrated. This product is sterilized by the user by the method described in the user manual.

| Device Name | Subject Device | Predicate Device | Predicate Device | |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|----------------------------------|--|
| Manufacturer | SHINHUNG MST CO.,<br>LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO.,<br>LTD. | |
| Device Name | Angled Abutment | ComOcta Angled<br>Abutment | Angled Abutment | |
| Design | Image: angled abutment | Image: angled abutment | Image: angled abutment | |
| 510(k) Number | K221752 | K120847 | K123155 / K160106 | |
| Angle (°) | 15, 20 | 15, 20 | 15, 25 | |
| Diameter(mm) | 3.7, 4.8 | 4.8, 6.0 | 4.6, 5.6 | |
| Material | Pure Titanium Gr 4<br>(ASTM F67) | Titanium Alloy Ti-6Al-4V<br>(ASTM F136) | Pure Titanium Gr 4<br>(ASTM F67) | |
| Sterilization | User sterile | User sterile | User sterile | |
| S.E. | This product has the same purpose as the predicate device and has a size within the<br>product size range of Osstem. The raw material is the same as the predicate device<br>(K123155). In addition, it is manufactured through the same manufacturing process as<br>our Luna Dental Implant System. Our previously approved product, Luna Dental<br>Implant System (k123155), uses the same raw materials as the applied product, but<br>only a part of it is coated with TiN. However, the whole is not coated with TiN, and it<br>can be seen that the portion with TiN coating is the worst case in terms of<br>biocompatibility. Thus, the safety of the raw material is demonstrated. This product is<br>sterilized by the user by the method described in the user manual. | | | |

| Device Name | Subject Device | Predicate Device | |
|---------------|------------------------------|--------------------------------|--------------------------------------|
| Manufacturer | SHINHUNG MST CO.,<br>LTD. | Osstem Implant Co., Ltd. | SHINHUNG MST CO.,<br>LTD. |
| Device Name | Temporary Abutment | ComOcta Temporary<br>Abutment | Temporary Abutment |
| Design | Image: Subject Device Design | Image: Predicate Device Design | Image: SHINHUNG MST CO., LTD. Design |
| 510(k) Number | K221752 | K120847 | K123155 |
| Diameter (mm) | 5.3, 6.5 | 4.8, 6.0 | 4.1, 4.6 |

{10}------------------------------------------------

| Gingiva Height<br>(mm) | 1.0 | 0, 2.0 | 1.0, 3.0 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Length (mm) | 12.25, 13.55 | 10.0…