Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a dental implant system and its components. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The performance studies focus on mechanical properties, sterilization, shelf-life, MRI compatibility, bacterial endotoxin, and biocompatibility, which are standard evaluations for this type of medical device.

Therapeutic

Yes.

Explanation: The device is an implant system designed to support dental prostheses in edentulous mandibles and maxillae, which directly treats a medical condition (edentulism) by restoring function and aesthetics.

Diagnostic

No

This device is a dental implant system used to support restorations; it does not diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "surgical component that interfaces with the bone of the jaw" and mentions "fixture, abutment and prosthetic components and tools," indicating it is a physical medical device, not software.

IVD (In Vitro Diagnostic)

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.
Device Description: The SNUCONE Bone Level Implant System is a surgical component that is implanted into the bone of the jaw to support dental prostheses. This is an invasive procedure performed within the body.
Intended Use: The intended use describes supporting dental restorations in the mouth, not performing diagnostic tests on bodily samples.

The provided information clearly describes a surgically implanted medical device, not a device used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

SNUCONE Bone 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 Bone Level 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.

Product codes

DZE, NHA

Device Description

SNUCONE Implant System Fixture, also known as an endosseous implant, is surgical component that interfaces with the bone of the jaw 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.

Fixtures and Cover Screw
There are 1 type of fixture and the dimensions and specification are as following:

Product: AF+B
Appearance: Image: AF+B Implant
Platform Diameter: Ø3.5, Ø4.0, Ø4.3, Ø4.8, Ø5.3, Ø5.8, Ø6.3, Ø6.8
Implant Length:
Ø3.5: 7,8,9,10,11,12,13,14mm
Ø4.0: 7,8,9,10,11,12,13,14mm
Ø4.3: 7,8,9,10,11,12,13,14mm
Ø4.8: 7,8,9,10,11,12,13,14mm
Ø5.3: 7,8,9,10,11,12,13,14mm
Ø5.8: 7,8,9,10,11,12,13,14mm
Ø6.3: 7,8,9,10,11,12,13,14mm
Ø6.8: 7,8,9,10,11,12,13,14mm
Surface Treatment: Acid etching
Implant-to-Abutment connection: Internal Hex
Material: Titanium Gr4 (ASTM F67)
Sterilization: Gamma irradiation
Shelf life: 5years

Product: Cover Screw
Appearance: Image: Cover Screws
Diameter: Ø3.3/Ø3.6
Length: 5.3/6.6mm
Surface Treatment: Anodizing
Material: Ti 6Al-4V ELI (ASTM F136)
Sterilization: Gamma irradiation
Shelf life: 5years

Tolerance of dimension shall be within ± 1% range.

Abutment and Component
2-1) Abutment
Dimensions and features of abutment are as following:

Abutment: Abiding Healing Abutment
Picture: Image: Abiding Healing Abutment
Use: This device is used to connect with Fixture to help gum tissue around the implant site heal faster.
Profile Diameter: Ø4.4 Ø4.9 Ø5.4 Ø5.9 Ø6.9 Ø7.9 Ø8.9 Ø9.9
Gingival Height: 1.0~5.5mm
Post Height: 2.0/2.5/3.0
Angle(°): N/A
Anodizing: Pink, Blue
Prosthetic retention: -
Restoration: -
Material: Ti 6Al-4V ELI (ASTM F136)
Sterilization: End-user sterilized
Shelf life: N/A

Abutment: Abiding Solo Abutment
Picture: Image: Abiding Solo Abutment
Use: This device is a one-piece abutment that is secured to the Fixture without other component.
Profile Diameter: Ø4.0 Ø4.5 Ø5.5 Ø6.5
Gingival Height: 1.0~5.5mm
Post Height: 4.0/5.5/7.0
Angle(°): N/A
Anodizing: N/A
Prosthetic retention: Cement-retained
Restoration: Single-unit Multi-unit
Material: Ti 6Al-4V ELI (ASTM F136)
Sterilization: End-user sterilized
Shelf life: N/A

Abutment: Abiding Couple Abutment
Picture: Image: Abiding Couple Abutment
Use: This device is a two-piece abutment that is secured to the Fixture with an abutment screw.
Profile Diameter: Ø4.0 Ø4.5 Ø5.0 Ø5.5 Ø6.5
Gingival Height: 1.0~7.5mm
Post Height: 5.5/7.0
Angle(°): N/A
Anodizing: N/A
Prosthetic retention: Cement-retained
Restoration: Single-unit Multi-unit
Material: Ti 6Al-4V ELI (ASTM F136)
Sterilization: End-user sterilized
Shelf life: N/A

Abutment: Abiding Couple Angled Abutment
Picture: Image: Abiding Couple Angled Abutment
Use: This device is a two-piece abutment that is secured to the Fixture with an abutment screw.
Profile Diameter: Ø4.0 Ø4.5 Ø5.0 Ø5.5 Ø6.5
Gingival Height: 1.0~6.0mm
Post Height: 7.0
Angle(°): 15°, 25°
Anodizing: Yellow
Prosthetic retention: Cement-retained
Restoration: Single-unit Multi-unit
Material: Ti 6Al-4V ELI (ASTM F136)
Sterilization: End-user sterilized
Shelf life: N/A

Abutment: Abiding Ti-Temporary Abutment
Picture: Image: Abiding Ti-Temporary Abutment
Use: This device is a two-piece abutment that is temporarily fixed to the Fixture with an abutment screw. This device is intended to be used for a maximum timeframe of 6 months.
Profile Diameter: Ø4.0 Ø4.5
Gingival Height: 1.0mm
Post Height: 10.0mm
Angle(°): N/A
Anodizing: N/A
Prosthetic retention: Screw-retained
Restoration: Single-unit Multi-unit
Material: Ti 6Al-4V ELI (ASTM F136)
Sterilization: End-user sterilized
Shelf life: N/A

Abutment: Abiding Screw Abutment
Picture: Image: Abiding Screw Abutment
Use: This device is a one-piece abutment and Abiding Screw Abutment is always to be used with the Ti-Cylinder for single-unit restorations.
Profile Diameter: Ø4.9
Gingival Height: 1.0~4.0mm
Post Height: -
Angle(°): N/A
Anodizing: Yellow
Prosthetic retention: Screw-retained
Restoration: Single-unit Multi-unit
Material: Ti 6Al-4V ELI (ASTM F136)
Sterilization: End-user sterilized
Shelf life: N/A

Tolerance of dimension shall be within ± 1% range.

2-2) Abutment Screw
Dimensions and features of abutment screw are as following:

Abutment Screw: Abiding Retaining Screw
Use: This product is a screw used to connect Abiding screw Abutment to Screw Ti-cylinder.
Size: D : Ø2.0, Ø2.05, Ø2.3 / L : 4.4~6.0mm
Material: Ti 6Al-4V ELI (ASTM F136)
Sterilization: End-user sterilized

Abutment Screw: Abiding Abutment Screw
Use: This product is a screw used to connect both two-piece Abutment to the Fixture
Size: D : Ø2.2, Ø2.25 / L : 9.4~10.6mm
Material: Ti 6Al-4V ELI (ASTM F136)
Sterilization: End-user sterilized

Tolerance of dimension shall be within ± 1% range.

2-3) Component - Cylinder
Dimensions and features of Ti-Cylinder are as following:

Cylinder: Screw Abutment Ti-Cylinder
Picture: Image: Screw Abutment Ti-Cylinder
Use: This product is a two-piece cylinder that is secured to the Abiding Screw Abutment with retaining screw.
Size: D: Ø4.9 L: 12.7mm
Minimum Post Height: 4mm
Material: Ti 6Al-4V ELI (ASTM F136)
Sterilization: End-user sterilized

Tolerance of dimension shall be within ± 1% range.

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Mandibles and maxillae

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)

Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device with the following standards:

The subject device was tested to evaluate its substantial equivalence according to the following standards.

Mechanical Performance
- Fatigue testing for Mini and Regular platform implant bodies with 25° Abiding Couple Angled Abutments was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and "ISO 14801:2016 Dentistry -Fatigue test for endosseous dental implants" under the worst case scenario.
- SEM/EDS analysis for worst-case implant body was conducted to confirm removal of the surface treatment media according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.".
Sterilization, Shelf-life and Packaging for Sterile Product
- End User Sterilization Validation according to ISO 17665-1:2006, ISO 17665-2:2009, ISO 11737-1:2006, and ISO 11737-2:2009
- Gamma sterilization validation according to ISO 11737-1:2006, and ISO 11737-2:2009
- Accelerating aging test according to ASTM F1980-16, ASTM F1140-13, ASTM F1140-13, ASTM F1929-15, and ASTM F2096-11
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic SNUCONE Bone Level Implant System devices in the MRI environment using scientific rationale 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): 783-775), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Bacterial Endotoxin
- ANSI/AAMI ST72:2019 Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing
Biocompatibility
Subject device has been evaluated for biocompatibility according to ISO 10993

The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K181138

Reference Device(s)

K141159, K193234, K203554

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & 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.

SNUCONE Co., LTD. % Sanglok Lee Manager Wise Company Inc. #507, #508, 166 Gasan digital 2-ro Geumcheon-gu, Seou 08503 KOREA, SOUTH

Re: K210354

Trade/Device Name: SNUCONE Bone Level Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 8, 2022 Received: June 10, 2022

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

1

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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,

for Andrew 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 Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K210354

Device Name SNUCONE Bone Level Implant System

Indications for Use (Describe)

SNUCONE Bone 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 Bone Level 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)
--------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

The assigned 510(k) Number: K210354

01. Date Prepared: July 12, 2022

02. Applicant

Company name: SNUCONE Co., LTD. Address: 5, Seongseo-ro 75-gil, Dalseo-gu, Daegu, Korea TEL: 82.53.592.7525 FAX: 82.53.592.7524 Email: snucone@naver.com

03. Submission Correspondent

Sanglok, Lee Wise COMPANY Inc. #303, 142, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org

04. Proposed Device Identification

Trade Name: SNUCONE Bone 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 Bone 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 Bone Level 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

K181138, IS-III active System manufactured by NEOBIOTECH CO., LTD.

Reference devices

K141159, KONUS DENTAL IMPLANT SYSTEM by Argon Med Productions & Vertriebs Gesellschaft mbH&Co.KG
K193234, NUVO IF Implant System by JJGC Indústria e Comércio de Materiais Dentários S.A.
K203554, AnyOne External 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 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 are 1 type of fixture and the dimensions and specification are as following:

Product	AF+B
Appearance	Image: AF+B Implant
Platform Diameter	Ø3.5, Ø4.0, Ø4.3, Ø4.8, Ø5.3, Ø5.8, Ø6.3, Ø6.8
Implant Length	Ø3.5: 7,8,9,10,11,12,13,14mm
Ø4.0: 7,8,9,10,11,12,13,14mm
Ø4.3: 7,8,9,10,11,12,13,14mm
Ø4.8: 7,8,9,10,11,12,13,14mm
Ø5.3: 7,8,9,10,11,12,13,14mm
Ø5.8: 7,8,9,10,11,12,13,14mm
Ø6.3: 7,8,9,10,11,12,13,14mm
Ø6.8: 7,8,9,10,11,12,13,14mm
Surface
Treatment	Acid etching
Implant-to-
Abutment
connection	Internal Hex
Material	Titanium Gr4 (ASTM F67)
Sterilization	Gamma irradiation
Shelf life	5years
Product	Cover Screw
Appearance	Image: Cover Screws
Diameter	Ø3.3/Ø3.6
Length	5.3/6.6mm
Surface
Treatment	Anodizing
Material	Ti 6Al-4V ELI (ASTM F136)
Sterilization	Gamma irradiation
Shelf life	5years

Tolerance of dimension shall be within ± 1% range.

5

2) Abutment and Component

2-1) Abutment

Dimensions and features of abutment are as following:

| Abutment | Abiding Healing Abutment | Abiding Solo Abutment | Abiding Couple Abutment | Abiding Couple Angled
Abutment |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Picture | Image: Abiding Healing Abutment | Image: Abiding Solo Abutment | Image: Abiding Couple Abutment | Image: Abiding Couple Angled Abutment |
| Use | This device is used to
connect with Fixture to
help gum tissue around the
implant site heal faster. | This device is a one-piece
abutment that is secured to
the Fixture without other
component. | This device is a two-piece
abutment that is secured to
the Fixture with an
abutment screw. | This device is a two-piece
abutment that is secured to
the Fixture with an
abutment screw. |
| Profile Diameter | Ø4.4 Ø4.9 Ø5.4 Ø5.9
Ø6.9 Ø7.9 Ø8.9 Ø9.9 | Ø4.0 Ø4.5 Ø5.5 Ø6.5 | Ø4.0 Ø4.5 Ø5.0
Ø5.5 Ø6.5 | Ø4.0 Ø4.5 Ø5.0
Ø5.5 Ø6.5 |
| Gingival Height | 1.0~~5.5mm | 1.0~~5.5mm | 1.0~~7.5mm | 1.0~~6.0mm |
| Post Height | 2.0/2.5/3.0 | 4.0/5.5/7.0 | 5.5/7.0 | 7.0 |
| Angle(°) | N/A | N/A | N/A | 15°, 25° |
| Anodizing | Pink, Blue | N/A | N/A | Yellow |
| Prosthetic
retention | - | Cement-retained | Cement-retained | Cement-retained |
| Restoration | - | Single-unit
Multi-unit | Single-unit
Multi-unit | Single-unit
Multi-unit |
| Material | Ti 6Al-4V ELI
(ASTM F136) | Ti 6Al-4V ELI
(ASTM F136) | Ti 6Al-4V ELI
(ASTM F136) | Ti 6Al-4V ELI
(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 | Abiding Ti-Temporary
Abutment | Abiding Screw Abutment | | |
| Picture | Image: Abiding Ti-Temporary Abutment | Image: Abiding Screw Abutment | | |
| Use | This device is a two-piece
abutment that is
temporarily fixed to the
Fixture with an abutment
screw. This device is
intended to be used for a
maximum timeframe of 6
months. | This device is a one-piece
abutment and Abiding
Screw Abutment is always
to be used with the Ti-
Cylinder for single-unit
restorations. | | |
| Profile Diameter | Ø4.0 Ø4.5 | Ø4.9 | | |
| Gingival Height | 1.0mm | 1.0~4.0mm | | |
| Post Height | 10.0mm | - | | |
| Angle(°) | N/A | N/A | | |
| Anodizing | N/A | Yellow | | |
| Prosthetic
retention | Screw-retained | Screw-retained | | |
| Restoration | Single-unit
Multi-unit | Single-unit
Multi-unit | | |
| Material | Ti 6Al-4V ELI
(ASTM F136) | Ti 6Al-4V ELI
(ASTM F136) | | |
| Sterilization | End-user sterilized | End-user sterilized | | |
| Shelf life | N/A | N/A | | |

6

Tolerance of dimension shall be within ± 1% range.

2-2) Abutment Screw

Dimensions and features of abutment screw are as following:

Abutment Screw	Abiding Retaining Screw	Abiding Abutment Screw
Picture
Use	This product is a screw used to connect Abiding
screw Abutment to Screw Ti-cylinder.	This product is a screw used to connect both two-
piece Abutment to the Fixture
Size	D : Ø2.0, Ø2.05, Ø2.3 / L : 4.4~6.0mm	D : Ø2.2, Ø2.25 / L : 9.4~10.6mm
Material	Ti 6Al-4V ELI (ASTM F136)	Ti 6Al-4V ELI (ASTM F136)
Sterilization	End-user sterilized	End-user sterilized

Tolerance of dimension shall be within ± 1% range.

2-3) Component - Cylinder

Dimensions and features of Ti-Cylinder are as following:

Cylinder	Screw Abutment Ti-Cylinder
Picture	Image: Screw Abutment Ti-Cylinder
Use	This product is a two-piece cylinder that is secured
to the Abiding Screw Abutment with retaining
screw.
Size	D: Ø4.9
L: 12.7mm
Minimum Post
Height	4mm
Material	Ti 6Al-4V ELI (ASTM F136)
Sterilization	End-user sterilized

Tolerance of dimension shall be within ± 1% range.

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

7

08. Substantial Equivalence Comparison

Fixture

Subject Device	Primary Predicate		Reference device		Design	Image: Implant	Image: Implant	Image: Implant	Image: Implant	Image: Implant
Company	SNUCONE Co., LTD.	Neobiotech Co., Ltd	Argon Med Productions&Vertriebs
Gesellschaft mbH&Co.KG	JJGC Indústria e Comércio de
Materiais
Dentários S.A.	MegaGen Implant Co., Ltd.	Connection	Internal Hex	Internal Hex	Internal Hex	Internal Hex	External Hex
Device Name	AF+B Fixture
for SNUCONE Bone Level
Implant System	IS-III active System	K3Pro Konus Dental Implant
System	NUVO IF Implant System	AnyOne Esxternal Fixture	Diameters(Ø)	Ø3.5, Ø4.0, Ø4.3, Ø4.8,
Ø5.3, Ø5.8, Ø6.3, Ø6.8	3.5/4.0/4.5/5.0/5.5/6.0/7.0	3.0-6.0mm	3.5mm, 3.75mm, 4.3mm, 5.0mm	Ø3.9 x 7.0, 8.0, 9.5, 11.0, 12.5,
14.5mm
Ø4.3 x 7.0, 8.0, 9.5, 11.0, 12.5,
14.5mm
Ø4.8 x 7.0, 8.0, 9.5, 11.0, 12.5,
14.5mm
Ø5.3 x 7.0, 8.0, 9.5, 11.0, 12.5,
14.5mm
Ø5.8 x 7.0, 8.0, 9.5, 11.0, 12.5,
14.5mm
Ø6.3 x 7.0, 8.0, 9.5, 11.0, 12.5,
14.5mm
Ø6.8 x 7.0, 8.0, 9.5, 11.0, 12.5,
14.5mm
510(k) Number	K210354	K181138	K141159	K193234	K203554	Lengths(mm)	Ø3.5: 7,8,9,10,11,12,13,14mm
Ø4.0: 7,8,9,10,11,12,13,14mm
Ø4.3: 7,8,9,10,11,12,13,14mm
Ø4.8: 7,8,9,10,11,12,13,14mm
Ø5.3: 7,8,9,10,11,12,13,14mm
Ø5.8: 7,8,9,10,11,12,13,14mm
Ø6.3: 7,8,9,10,11,12,13,14mm
Ø6.8: 7,8,9,10,11,12,13,14mm	7.3/8.5/10.0/11.5/13.0/15.0	7.5-17mm	3.5mm: 7,10,11.5,13,16,18mm
3.75mm: 7,10,11.5,13,16,18mm
4.3mm: 7,10,11.5,13,16,18mm
5.0mm: 7,10,11.5,13,16mm	Ø3.9 x 7.0, 8.0, 9.5, 11.0, 12.5,
14.5mm
Ø4.3 x 7.0, 8.0, 9.5, 11.0, 12.5,
14.5mm
Ø4.8 x 7.0, 8.0, 9.5, 11.0, 12.5,
14.5mm
Ø5.3 x 7.0, 8.0, 9.5, 11.0, 12.5,
14.5mm
Ø5.8 x 7.0, 8.0, 9.5, 11.0, 12.5,
14.5mm
Ø6.3 x 7.0, 8.0, 9.5, 11.0, 12.5,
14.5mm
Ø6.8 x 7.0, 8.0, 9.5, 11.0, 12.5,
14.5mm
Device
Classification
Name	Implant, Endosseous,
Root-Form	Implant, Endosseous,
Root-Form	Implant, Endosseous,
Root-Form	Implant, Endosseous,
Root-Form	Implant, Endosseous, Root-Form	Surface
Treatment	Acid etching	SLA	Acid etched	Sand blasted and acid etched	Sand-blasted, Large grit, Acid-
etched (SLA)
Product Code	DZE	DZE	DZE	DZE	DZE	Sterilization	Gamma Sterilization	Gamma Sterilization	Gamma Sterilization	Gamma Irradiation to an SAL of
$1 \times 10^{-6}$	Gamma sterilization
Regulation
Number	872.3640	872.3640	872.3640	872.3640	872.3640	Principle of
Operation	This product is a root-type fixture
which is inserted in the alveolar
bone. It replaces the functions of
the missing teeth as a dental
implant fixture.	This product is a root-type fixture
which is inserted in the alveolar
bone. It replaces the functions of
the missing teeth as a dental
implant fixture.	Unknown	Unknown	It is a tapered body fixture which is
inserted in the alveolar bone. It
replaces the functions of the
missing teeth as a dental implant
fixture,
Indications for
Use	SNUCONE Bone 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, screw retained, or
overdenture restorations and
terminal or intermediate
Abutment support for fixed bridge
work. SNUCONE Bone Level
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.	The IS-III active System is
indicated for use in partially or
fully edentulous mandibles and
maxillae, in support of single or
multiple-unit restorations
including; cemented retained,
screw retained, or overdenture
restorations, and terminal or
intermediate Abutment support
for fixed bridgework. IS-III active
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.	The Konus K3Pro and K3Pro
Rapid Implant is designed for use
in edentulous sites in the mandible
or maxilla for support of a
complete denture prosthesis, a
terminal or intermediate abutment
for fixed bridgework or for partial
dentures, or as a single tooth
replacement.	The NUVO IF Implant System is
intended to be surgically placed in
the maxilla or mandible to provide
support for prosthetic devices such
as artificial teeth in order to restore
chewing function. It may be used
with single-stage or two-stage
procedures, for single or multiple
unit restorations, and may be
loaded immediately when good
primary stability is achieved and
with appropriate occlusal loading.
Multiple tooth applications may be
rigidly splinted.
The Titanium Temporary Abutment
is indicated to provide temporary
support for prosthesis structure for
up to 6 months.
The Attachment Equator and
Attachment Removable Prosthesis
abutments are indicated for the
attachment of full or partial
dentures to NUVO implants.	The AnyOne External Implant
System is intended to be surgically
placed in the maxillary or
mandibular molar areas for the
purpose providing prosthetic
support for dental restorations
(Crown, bridges, and
overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing
function. Smaller implants (less
than 6.0mm) are dedicated for
immediate loading when good
primary stability is achieved and
with appropriate occlusal loading.
Larger implants are dedicated for
the molar region and are indicated
for delayed loading.	Similarities	SNUCONE Bone Level Implant System has the same device characteristics with the Primary predicates such as diameters, Length, intended use, material, principle of operation
connection design, design, structure, sterilization method-
Material	Titanium Gr4 (ASTM F67)	TI CP4 of ASTM F67	Pure Titanium Grade 4	Commercially Pure Titanium
(Grade 4)	CP Ti Grade 4
(ASTM F67-13)	Differences	K193234 was provided as a reference device for combinations of 3.5 diameters and 7mm lengths.
K203554 was provided as a reference device for combinations of diameter and lengths except for 3.5 diameters and 7mm lengths.
In addition, the surface treatment of the is acid etched method, while the primary predicate is SLA method. To support this inconsistency, K141159 is added as a reference device
to support the difference in surface treatment method.

8

1-2) Cover Screw

	Subject Device	Primary Predicate
Company	SNUCONE Co., LTD.	Neobiotech Co., Ltd
Device Name	Cover Screw
for SNUCONE Bone Level Implant System	IS-III active System
510(k) Number	K210354	K181138

9

Material	Ti-6Al-4V ELI of ASTM F136	Ti-6Al-4V ELI of ASTM F136
Design	Image: blue and purple dental implant	Image: grey and yellow dental implant
Diameters(Ø)	Ø3.3 Ø3.6	3.45/3.6
Lengths(mm)	5.3/6.6mm	5.85/6.85/7.45/ 6.4/7.4/8.0
Anodizing	Anodizing	Anodizing/ Non-Anodizing,
Sterilization	Gamma irradiation	Gamma irradiation
Principle of
Operation	It is used for protecting inner hole and connecting part with exposed upper part of
structure during the healing period after inserting dental implant fixture. When inserting
the Abutment, Cover screw is removed.	It is used for protecting inner hole and connecting part with exposed upper part of
structure during the healing period after inserting dental implant fixture. When inserting
the Abutment, Cover screw is removed.
Similarities	The Subject device and the primary predicate have the same material, anodizing characteristics, sterilization method, and principle of operation, and the diameter and length
are similar.

2) Abutment, Abutment screw and Component

2-1) Abiding Healing Abutment

	Subject Device	Primary Predicate
Company	SNUCONE Co., LTD.	Neobiotech Co., Ltd.
Device Name	Abiding Healing Abutment
for SNUCONE Bone Level Implant System	IS-III active System
510(k) Number	K210354	K181138
Material	Ti-6Al-4V ELI of ASTM F136	Ti-6Al-4V ELI of ASTM F136
Design	Image: purple and blue abutment	Image: silver abutment
Diameters( $Ø$ )	$Ø$ 4.4 $Ø$ 4.9 $Ø$ 5.4 $Ø$ 5.9
$Ø$ 6.9 $Ø$ 7.9 $Ø$ 8.9 $Ø$ 9.9	4.0/4.5/4.8/5.5/6.0/6.8/8.0/9.0
Gingival
Height(mm)	1.0~5.5mm	2.3/2.8/3.3/3.8/4.3/4.8/5.3/5.8/6.3/6.8/7.8
Anodizing	Anodizing	N/A
Sterilization	Non-Sterilization	Gamma irradiation
Principle of	This product is healing Abutment to formation appropriate gingival shape during the	This product is healing Abutment to formation appropriate gingival shape during the

10

Operation	soft tissue healing period combined with implant. This product should be removed when the superstructure is set up.	soft tissue healing period combined with implant. This product should be removed when the superstructure is set up.
Similarities	The subject device has the same principle of operation, material, design and similar diameter and length as the reference device.

2-2) Abiding Solo Abutment

	Subject Device	Reference device
Company	SNUCONE Co., LTD.	JJGC Indústria e Comércio de Materiais
Dentários S.A.
Device Name	Abiding Solo Abutment
for SNUCONE Bone Level Implant System	NUVO IF Implant System
510(k) Number	K210354	K193234
Material	Ti-6Al-4V ELI of ASTM F136	Titanium Alloy (Ti-6Al-4V)
Design	Image: Abiding Solo Abutment	Image: NUVO IF Implant System
Diameters(Ø)	Ø4.0 Ø4.5 Ø5.5 Ø6.5	Platform Ø3.5(NP) Ø4.5(SP)
Gingival
Height(mm)	1.0~5.5mm	0.5, 1.2, 1.5, 3mm
Surface
Treatment	N/A	Machined and anodized (only NP platform)
Principle of
Operation	This Product is one-piece cement retained restoration, connected with fixture and
cemented crown on the Abutment.	Abutment designed to accept a cement-retained prosthetic.
Similarities	The subject device and reference device have the similar technological characteristic, and are made of same materials. The subject device and reference device have similar
physical dimensions, including diameter and lengths. Therefore, the subject device is substantially equivalent to the currently reference devices.

2-3) Abiding Couple / Abiding Couple Angled Abutment

	Subject Device	Primary Predicate
Company	SNUCONE Co., LTD.	Neobiotech Co., Ltd
Device Name	Abiding Couple, Couple Angled Abutment
for SNUCONE Implant System	IS-III active System
510(k) Number	K210354	K181138
Material	Ti-6Al-4V ELI of ASTM F136	Ti-6Al-4V ELI of ASTM F136

11

Design
	Hex	Non-Hex	Hex	Non-Hex	SCRP
Diameters(Ø)		Ø4.0 Ø4.5 Ø5.5 Ø6.5	4.5/5.2/5.7/6.5
Gingival
Height(mm)	1.0~7.5mm		1,2,3,4,5mm
Anodizing	Non-Anodizing		Non-Anodizing
Abiding Couple Angled Abutment
Design
	Hex, Non-Hex	Hex, Non-Hex	Hex		Non-Hex
Diameters(Ø)	Ø4.0 Ø4.5 Ø5.0 Ø5.5 Ø6.5		4.5/5.2/5.7
Gingival
Height(mm)	1.0~6.0mm		2,3,4mm
Angle (°)	15°, 25°		15/25
Anodizing	Non-Anodizing, Anodizing		Non-Anodizing
Principle of
Operation	This product is two-piece abutment that is indicated for screw-retained single tooth or
cement retained single tooth and bridge restorations.		It is indicated for screw-retained single tooth or cement retained single tooth and bridge
restorations.
Similarities	They are substantially equivalent in material, design, dimension, connection, functions. Subject device is similar in fundamental scientific technology to the primary predicate in
that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and
endosseous dental implant abutments.

2-4) Abiding Ti-Temporary Abutment

	Subject Device	Primary Predicate
Company	SNUCONE Co., LTD.	Neobiotech Co., Ltd
Device Name	Abiding Ti-Temporary Abutment
for SNUCONE Implant System	IS-III active System
510(k) Number	K210354	K181138
Material	Ti-6Al-4V ELI of ASTM F136	Ti-6Al-4V ELI of ASTM F136

12

Design
	Hex	Non-Hex	Hex	Non-Hex
Diameters(Ø)	Ø4.0 Ø4.5		4.5
Gingival	1.0mm		6.0/8.0/11.5
Height(mm)
Principle of
Operation	It is dental Abutments designed to serve as a temporary dental prosthesis during the
healing process until a permanent crown is made.		It is dental Abutments designed to serve as a temporary dental prosthesis during the
healing process until a permanent crown is made.
Maximum
timeframe for
use	≤ 6 month		Expected to be less than 6 month
Similarities	The subject device and primary predicate are substantially equivalent material, connection type, design, principle of operation, and maximum timeframe for use.

2-5) Abiding Screw Abutment

	Subject Device	Reference device
Company	SNUCONE Co., LTD.	JJGC Indústria e Comércio de Materiais
Dentários S.A.
Device Name	Abiding Screw Abutment
for SNUCONE Implant System	NUVO IF Implant System
510(k) Number	K210354	K193234
Material	Ti-6Al-4V ELI of ASTM F136	Titanium Alloy (Ti-6Al-4V)
Design	Image: Subject Device Design	Image: Reference Device Design
Diameters(Ø)	Ø4.9	Platform Ø3.5&4.8mm (NP), Ø4.8mm (SP)
Gingival
Height(mm)	1.0~4.0mm	NP – 0.5/1/2/2.3/3/4/5mm
SP – 1/2/2.3/3/4/5mm
Angle (°)	0°	0°, 17°, 30°
Anodizing	Non-Anodizing, Anodizing	Machined and anodized (only NP platform)
Similarities	The subject device and the reference device have same raw materials and designs, and have similar physical sizes such as diameter and height. Therefore, the subject device
and reference device are practically the similar.

13

2-6) Abutment Screw

	Subject Device		Primary Predicate
Company	SNUCONE Co., LTD.		Neobiotech Co., Ltd
Device Name	Abiding Retaining Screw	Abiding Abutment Screw	IS-III active System
510(k) Number	K210354	K210354	K181138
Material	Ti-6Al-4V ELI of ASTM F136	Ti-6Al-4V ELI of ASTM F136	Ti-6Al-4V ELI of ASTM F136
Design	Image: Abiding Retaining Screw	Image: Abiding Abutment Screw	Image: IS-III active System
Diameters(Ø)	Ø2.0, Ø2.05, Ø2.3	Ø2.2, Ø2.25	2.3
Lengths(mm)	4.4~6.0mm	9.4~10.6mm	8.8/8.3
Surface
Treatment	N/A	N/A	N/A
Principle of
Operation	This product is a screw for connected with Abutment and fixture.		This product is a screw for connected with Abutment and fixture.
Similarities	The subject device and primary predicate have same material, design, diameter, surface treatment, and principle of operation.
Differences	Differences in length are due to proprietary subject device dimensions and are supported by bench testing.

2-7) Component – Cylinder

	Subject Device	Reference device
Company	SNUCONE Co., LTD.	JJGC Indústria e Comércio de Materiais
Dentários S.A.
Device Name	Screw Abutment Ti-Cylinder for SNUCONE Implant System	NUVO IF Implant System
510(k) Number	K210354	K193234
Material	Ti-6Al-4V ELI of ASTM F136	Titanium Alloy (Ti-6Al-4V)
Design	Image: Screw Abutment Ti-Cylinder	Image: NUVO IF Implant System
Diameters(Ø)	Ø4.9	Not Available in 510(k) Summary
Lengths(mm)	12.7mm	Not Available in 510(k) Summary

14

Anodizing	Anodizing	Not Available in 510(k) Summary
Principle of
Operation	This product is connected to a Screw Abutment, and before installing the final
prosthesis, a temporary prosthesis is made and used in various cases such as over
denture and bridges.	Not Available in 510(k) Summary
Similarities	The subject device and the reference device have same raw materials and designs and have similar physical sizes such as diameter. Therefore, the subject device and
reference device are practically the similar.

15

09. Non-Clinical Test

Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device with the following standards:

The subject device was tested to evaluate its substantial equivalence according to the following standards.

· Mechanical Performance

Fatigue testing for Mini and Regular platform implant bodies with 25° Abiding Couple Angled Abutments was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and "ISO 14801:2016 Dentistry -Fatigue test for endosseous dental implants" under the worst case scenario.
SEM/EDS analysis for worst-case implant body was conducted to confirm removal of the surface treatment media according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.".

= Sterilization, Shelf-life and Packaging for Sterile Product

End User Sterilization Validation according to ISO 17665-1:2006, ISO 17665-2:2009, ISO 11737-1:2006, and ISO 11737-2:2009
Gamma sterilization validation according to ISO 11737-1:2006, and ISO 11737-2:2009
Accelerating aging test according to ASTM F1980-16, ASTM F1140-13, ASTM F1140-13, ASTM F1929-15, and ASTM F2096-11

▪ MR Environment Condition

Non-clinical worst-case MRI review was performed to evaluate the metallic SNUCONE Bone Level Implant System devices in the MRI environment using scientific rationale 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), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

▪ Bacterial Endotoxin

ANSI/AAMI ST72:2019 Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing

· Biocompatibility

Subject device has been evaluated for biocompatibility according to ISO 10993

The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device

10. Conclusion

SNUCONE Bone Level Implant System constitutes a substantially equivalent medical device. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, SNUCONE Bone Level Implant System and its predicate device are substantially equivalent.