SNUCONE Tissue Level Implant System

K222792 · Snucone Co., Ltd. · DZE · Jun 8, 2023 · Dental

Device Facts

• Record ID: K222792
• Device Name: SNUCONE Tissue Level Implant System
• Applicant: Snucone Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jun 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SNUCONE Tissue Level Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations and terminal or intermediate Abutment support for fixed bridge work. Snucone implant system is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

Device Story

Endosseous dental implant system; consists of titanium fixtures, cover screws, abutments, and abutment screws. Fixtures inserted into alveolar bone to support dental prostheses (crowns, bridges, dentures). System utilizes internal octa connection. Used in dental clinics by dentists/oral surgeons. Fixtures and cover screws sterilized via gamma irradiation; abutments/components sterilized by end-user. Provides structural foundation for tooth replacement; enables functional restoration of mastication. Benefits include improved oral function and aesthetics for edentulous patients.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via fatigue testing (ISO 14801) and SEM/EDS analysis. Biocompatibility assessed per ISO 10993. Sterilization and shelf-life validated per ISO 17665, ISO 11737, and ASTM F1980. MRI safety evaluated via scientific rationale and literature review.

Technological Characteristics

Materials: Titanium Gr4 (ASTM F67) for fixtures, Ti-6Al-4V ELI (ASTM F136) for abutments/screws. Surface treatment: Acid etching. Connection: Internal Octa. Sterilization: Gamma irradiation (fixtures/screws) or end-user (abutments). Dimensions: Diameters 3.7-5.8mm, lengths 7-14mm. Standalone dental implant system.

Indications for Use

Indicated for partially or fully edentulous mandibles and maxillae in patients requiring single or multiple-unit restorations (cement-retained, overdenture, or fixed bridge support). Dedicated for two-stage surgical procedures and immediate loading given sufficient primary stability and occlusal load. Implants >5mm indicated for molar regions.

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

• IT-III active System (K181137)

Reference Devices

• K3Pro Konus Dental Implant System (K141159)
• TS Implant System (K121585)
• IS-III active System (K181138)
• Luna Dental Implant System-Healing Abutment (K200189)
• CSM Internal-R Implant System (K120043)
• BEGO Semados® RS/RSX Implant System (K201700)
• Fit & Brilliant Dental Implant System (K190637)
• Any One Onestage Implant System (K210161)

Submission Summary (Full Text)

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

SNUCONE Co., Ltd. % Sanglok Lee Manager Wise Company Inc. #303, 142 Gasan digital 1-ro Geumcheon-gu. Seoul 08507 REPUBLIC OF KOREA

Re: K222792

Trade/Device Name: SNUCONE Tissue Level Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 8, 2023 Received: May 8, 2023

Dear Sanglok Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 ([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

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# Indications for Use

510(k) Number (if known)

K222792

Device Name

SNUCONE Tissue Level Implant System

#### Indications for Use (Describe)

SNUCONE Tissue Level Implant System is inticated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations and terminal or internediate Abutment support for fixed bridge work. Snucone implant system is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# The assigned 510(k) Number: K222792

## 01. Date Prepared: May 29, 2023

#### 02. Applicant

Company name: SNUCONE Co., LTD. Address: 5, Seongseo-ro 75-gil, Dalseo-qu, Daegu, Korea TEL: [phone] FAX: [phone] Email: [e-mail]

#### 03. Submission Correspondent

Sanglok, Lee Wise COMPANY Inc. #303, 142, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: [phone] FAX: [phone] Email: [e-mail]

## 04. Proposed Device Identification

Trade Name: SNUCONE Tissue Level Implant System Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Primary Product Code: DZE Secondary Product Code: NHA Panel: Dental Regulation Number: 21 CFR 872.3640 Device Class: Class II

#### 05. Indication for use

SNUCONE Tissue Level Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture and terminal or intermediate Abutment support for fixed bridge work. Snucone implant system is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

#### 06. Predicate and Reference Devices

Primary Predicate

- K181137, IT-III active System manufactured by NEOBIOTECH CO., LTD
#### Reference Devices

- K141159, K3Pro Konus Dental Implant System. Argon Med. Productions & Vertriebs Gesellschaft mbh & Co. KG
- K121585, TS Implant System by Osstem Implant Co., Ltd.
- K181138, IS-III active System manufactured by NEOBIOTECH CO., LTD
- K200189, Luna Dental Implant System-Healing Abutment, Shinhung MST CO., LTD
- K120043, CSM Internal-R Implant System, CSM Implant
- K201700, BEGO Semados® RS/RSX Implant System by BEGO Implant Systems GmbH & Co. KG
- K190637, Fit & Brilliant Dental Implant System, F&B Technology CO., LTD
- K210161, Any One Onestage Implant System by MegaGen Implant Co., Ltd.

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# 07. Device Description

SNUCONE Implant System Fixture, also known as an endosseous implant, is surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis such as a crown, bridge, denture. Snucone's abutment and prosthetic components and tools are compatible with the Snucone's fixture only.

1) Fixtures and Cover Screw

There is 1 type of fixture, and the dimensions and specification are as following:

| Product | EF | Cover Screw |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Picture | Image: EF Implant | Image: Cover Screws |
| Diameter | Ø3.7, Ø3.8, Ø4.1, Ø4.3,<br>Ø4.8, Ø5.3, Ø5.5, Ø5.8 | Ø5.5 / Ø6.7 |
| Length | Ø3.7: 7,8,9,10,11,12,13,14mm<br>Ø3.8: 7,8,9,10,11,12,13,14mm<br>Ø4.1: 7,8,9,10,11,12,13,14mm<br>Ø4.3: 7,8,9,10,11,12,13,14mm<br>Ø4.8: 7,8,9,10,11,12,13,14mm<br>Ø5.3: 7,8,9,10,11,12,13,14mm<br>Ø5.5: 7,8,9,10,11,12,13,14mm<br>Ø5.8: 7,8,9,10,11,12,13,14mm | 8mm |
| Surface<br>Treatment | Acid etching | Anodizing |
| Connection | Internal Octa | N/A |
| Material | Titanium Gr4 (ASTM F67) | Ti 6Al-4V ELI (ASTM F136) |
| Sterilization | Gamma irradiation | Gamma irradiation |
| Shelf Life | 5 years | 5 years |

Tolerance of dimension shall be within ± 1% range.

#### 2) Abutment and Component

2-1) Abutment

Dimensions and features of abutment are as following:

Tolerance of dimension shall be within ± 1% range.

| Abutment | Solid Abutment | InOcta Closing Screw | InOcta Healing Abutment | InOcta Abutment |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Picture | Image: Solid Abutment | Image: InOcta Closing Screw | Image: InOcta Healing Abutment | Image: InOcta Abutment |
| Use | This device is a one-piece<br>abutment that is secured<br>to the Fixture without other<br>component. | This device is connected to<br>the Fixture and is used<br>during healing period. | This device is used to<br>connect with Fixture to<br>help gum tissue around<br>the implant site heal faster. | This device is a two-piece<br>abutment that is secured<br>to the Fixture with an<br>abutment screw. |
| Principle of | This product is a | This device is used for | This product is healing | This product is a |
| Operation | superstructure which is<br>connects with the fixture. It<br>is a one-body type<br>Abutment of screw-<br>retained that does not<br>require an Abutment<br>screw. It replaces the<br>functions of the missing<br>teeth as a dental<br>Abutment. | protecting inner hole and<br>connecting part with<br>exposed upper part of<br>structure during the healing<br>period after inserting dental<br>implant fixture. When<br>inserting the Abutment, This<br>product is removed. | Abutment to formation<br>appropriate gingival shape<br>during the soft tissue<br>healing period combined<br>with implant. This product<br>should be removed when<br>the superstructure is set<br>up. | superstructure which is<br>connects with the fixture<br>using the enclosed<br>Abutment screw. It<br>replaces the functions of<br>the missing teeth as a<br>dental abutment. |
| Diameter | Ø3.5, Ø4.3 | Ø3.5 | Ø5.5, Ø6.1, Ø6.3 | Ø4.8, Ø5.2, Ø6.2 |
| Total Length | 9.5~13.0mm | 5.9mm | 9.0~11.5mm | 6.0~13.0mm |
| Gingival Height | - | - | 4.0~6.5mm | 0.0~4.0mm |
| Post Height | 4.0~7.0mm | - | - | 4.0~7.0mm |
| Angle(°) | N/A | N/A | N/A | N/A |
| Anodizing | N/A | Yellow | Yellow | N/A |
| Prosthetic<br>retention | Cement-retained | - | - | Cement-retained |
| Restoration | Single-unit<br>Multi-unit | - | - | Single-unit<br>Multi-unit |
| Material | Ti 6Al-4V ELI<br>(ASTM F136) | Ti 6Al-4V ELI<br>(ASTM F136) | Ti 6Al-4V ELI<br>(ASTM F136) | Ti 6Al-4V ELI<br>(ASTM F136) |
| Sterilization | End user sterilized | End user sterilized | End user sterilized | End user sterilized |
| Shelf Life | N/A | N/A | N/A | N/A |
| Abutment | InOcta Angled<br>Abutment | InOcta Temporary Abutment | Platform Switching<br>Abutment | - |
| Picture | Image: InOcta Angled Abutment | Image: InOcta Temporary Abutment | Image: Platform Switching Abutment | - |
| Use | This device is a two-piece<br>abutment that is secured<br>to the Fixture with an<br>abutment screw. | This device is a two-piece<br>abutment that is temporarily<br>fixed to the Fixture with an<br>abutment screw. This device<br>is intended to be used for a<br>maximum timeframe of 6<br>months. | This device is a one-piece<br>abutment that is secured<br>to the Fixture without other<br>component. | - |
| Principle of<br>Operation | This product is a<br>superstructure which is<br>connects with the fixture<br>using the enclosed<br>Abutment screw. It<br>replaces the functions of<br>the missing teeth as a<br>dental abutment. | It is dental Abutments<br>designed to serve as a<br>temporary dental prosthesis<br>during the healing process<br>until a permanent crown is<br>made. | This product is a<br>superstructure which is<br>connects with the fixture<br>using the enclosed<br>Abutment screw. It<br>replaces the functions of<br>the missing teeth as a<br>dental abutment. | |
| Diameter | Ø3.8 | Ø5.2 | Ø4.5, Ø5.5, Ø6.5 | - |
| Total Length | 9.5mm | 12.5~14.5mm | 9.9~16.9mm | |
| Gingival Height | - | 1.0~3.0mm | 0.0~5.5mm | |
| Post Height | 7.0mm | 9.5mm | 5.5mm | - |
| Angle(°) | 15° 25° | N/A | N/A | - |
| Anodizing | N/A | N/A | N/A | - |
| Prosthetic<br>retention | Cement-retained | Cement-retained | Cement-retained | |
| Restoration | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit | |
| Material | Ti 6Al-4V ELI<br>(ASTM F136) | Ti 6Al-4V ELI<br>(ASTM F136) | Ti 6Al-4V ELI<br>(ASTM F136) | |
| Sterilization | End user sterilized | End user sterilized | End user sterilized | |
| Shelf Life | N/A | N/A | N/A | - |

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# 2-2) Abutment Screw

Dimensions and features of component are as following:

| Abutment Screw | InOcta Abutment Screw |
|---------------------------|-----------------------------------------------------------------------------------|
| Picture | Image: Abutment Screw |
| Use | This product is a screw used to connect both two-piece<br>Abutment to the Fixture |
| Principle of<br>Operation | This product is a screw for connected with Abutment<br>and fixture. |
| Size | D : Ø2.5 / L : 4.5~8.0mm |
| Material | Ti 6Al-4V ELI (ASTM F136) |
| Sterilization | End user sterilized |

Tolerance of dimension for InOcta Abutment screw shall be within ± 1% range.

Fixture is packaged with Cover Screw, Abutment is packaged with single-packing or components, in some cases.

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# 08. Substantial Equivalence Comparison

1) Fixture

| | Subject Device | Primary Predicate | Reference Device |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd | Argon Med Productions&Vertriebs Gesellschaft<br>mbH&Co.KG |
| Device Name | EF Fixture for SNUCONE Tissue Level Implant System | IT-III active System | K3Pro Konus Dental Implant |
| 510(k) Number | Not Assigned Yet. | K181137 | K141159 |
| Device<br>Classification<br>Name | Implant, Endosseous,<br>Root-Form | Implant, Endosseous,<br>Root-Form | Implant, Endosseous,<br>Root-Form |
| Product Code | DZE | DZE | DZE |
| Regulation Number | 872.3640 | 872.3640 | 872.3640 |
| Indications for Use | SNUCONE Tissue Level Implant System is indicated for<br>use in partially or fully edentulous mandibles and<br>maxillae, in support of single or multiple-unit restorations<br>including; cemented retained, or overdenture<br>restorations and terminal or intermediate Abutment<br>support for fixed bridge work. Snucone implant system<br>is dedicated for two stage surgical procedures and for<br>immediate loading when there is good primary stability<br>and an appropriate occlusal load. Also, implants with<br>diameters larger than 5mm are indicated for molar<br>regions. | The IT-III active system is indicated for use in partially or<br>fully edentulous mandibles and maxillae, in support of<br>single or multiple-unit restorations including; cemented<br>retained, or overdenture restorations and terminal or<br>intermediate Abutment support for fixed bridge work. IT-<br>III active system is dedicated for two stage surgical<br>procedures and for immediate loading when there is<br>good primary stability and an appropriate occlusal<br>loading. | The Konus K3Pro and K3Pro Rapid Implant is designed<br>for use in edentulous sites in the mandible or maxilla for<br>support of a complete denture prosthesis, a terminal or<br>intermediate abutment for fixed bridgework or for partial<br>dentures, or as a single tooth replacement. |
| Material | Titanium Gr4 (ASTM F67) | Pure Titanium of ASTM F67 | Pure Titanium Grade 4 |
| Design | Image: Two titanium implants | Image: Two titanium implants | Image: Two titanium implants |
| Connection | Internal Octa | Internal Octa | Internal Hex |
| Diameters(ø) | $Ø$ 3.7, $Ø$ 3.8, $Ø$ 4.1, $Ø$ 4.3, $Ø$ 4.8, $Ø$ 5.3, $Ø$ 5.5, $Ø$ 5.8 | 3.5/4.0/4.5/5.0/5.5/6.0/7.0 | 3.0-6.0mm |
| Lengths(mm) | $Ø$ 3.7: 7,8,9,10,11,12,13,14mm<br>$Ø$ 3.8: 7,8,9,10,11,12,13,14mm<br>$Ø$ 4.1: 7,8,9,10,11,12,13,14mm<br>$Ø$ 4.3: 7,8,9,10,11,12,13,14mm<br>$Ø$ 4.8: 7,8,9,10,11,12,13,14mm | 7.0/8.5/10.0/11.5/13.0/15.0 | 7.5-17mm |
| | Ø5.3: 7,8,9,10,11,12,13,14mm | | |
| | Ø5.5: 7,8,9,10,11,12,13,14mm | | |
| | Ø5.8: 7,8,9,10,11,12,13,14mm | | |
| Surface Treatment | Acid etching | SLA | Acid etching |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Principle of<br>Operation | This product is a root-type fixture which is inserted in the<br>alveolar bone. It replaces the functions of the missing<br>teeth as a dental implant fixture. | This product is a root-type fixture which is inserted in the<br>alveolar bone. It replaces the functions of the missing<br>teeth as a dental implant fixture. | Unknown |
| Similarities | SNUCONE Tissue Level Fixture has the same device characteristics with the primary predicate such as Indication for use, material, design, connection, diameter, length,<br>sterilization method, and principle of operation.<br>The surface treatment is applied to the threaded part only of the subject device and primary predicate. The upper portion of EF Fixture is pure titanium without surface<br>treatment | | |
| Differences | The difference between the subject device and the Predicate device are surface treatment. The surface treatment method of the subject fixture is Acid etching while the<br>primary predicate is SLA. To support this inconsistency, K141159 is added as a reference device to support the difference in surface treatment method. | | |

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# 1-2) Cover Screw

| | Subject Device | Primary Predicate | Reference Device |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd | Osstem Implant Co., Ltd. |
| Device Name | Cover screw for SNUCONE Tissue Level Implant<br>System | IT-III active System | TS Implant System |
| 510(k) Number | Not Assigned Yet. | K181137 | K121585 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Yellow and blue cover screw | Image: Gray cover screw | Image: Green cover screw |
| Diameters(ø) | Yellow: Ø5.5<br>Sky blue: Ø6.7 | 5.5/6.9 | 4.0/4.5/5.0/6.0/7.0 |
| Height (mm) | 3.0mm | Cuff Length: 6.0 | Height: 0.4, 1.4, 2.0 |
| Anodizing | Anodizing | Non-Anodizing | Anodizing |
| Sterilization | Gamma irradiation…