LW Implant System

K223924 · Ossvis Co., Ltd. · DZE · Aug 8, 2023 · Dental

Device Facts

• Record ID: K223924
• Device Name: LW Implant System
• Applicant: Ossvis Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Aug 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LW 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 bridgework. The LW Implant System is dedicated for two stage surgical procedures and is intended for delayed loading. Also, implants with diameters larger than 5mm are indicated for molar regions.

Device Story

Endosseous dental implant system; includes fixtures, cover screws, healing abutments, and various abutment types (solid, angled, Vis, temporary). Fixtures feature internal hex connection, submerged design, tapered/straight body, and SLA surface treatment. Used by dental clinicians in clinical settings to replace missing teeth and restore chewing function. Fixtures, cover screws, and healing abutments provided sterile; other components provided non-sterile for end-user sterilization. System supports prosthetic restorations via mechanical connection between fixture and abutment. Benefits include restoration of masticatory function and esthetics for edentulous patients.

Clinical Evidence

Bench testing only. Includes ISO 14801 dynamic fatigue and static compression testing, ISO 10993-5 cytotoxicity, USP <85>/<161> bacterial endotoxin testing, and sterilization validation (ISO 11137/17665). Surface modification (SLA) verified via SEM, surface roughness, and ICP analysis. MRI safety evaluated via scientific rationale and literature.

Technological Characteristics

Materials: CP Ti Grade 4 (ASTM F67) for fixtures/cover screws/healing abutments; Ti-6Al-4V-ELI (ASTM F136) for abutments. Design: Internal hex, submerged, tapered/straight body, SLA surface treatment. Sterilization: Gamma irradiation (sterile components) or moist heat (non-sterile components).

Indications for Use

Indicated for partially or fully edentulous adult patients requiring single or multiple-unit dental restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support. Dedicated for two-stage surgical procedures with delayed loading. Implants >5mm diameter 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

• IS-III active System (K181138)

Reference Devices

• OneQ-SL s-Clean Implant System (K153639)
• Xpeed AnyRidge Internal Implant System (K140091)
• HIOSSEN Implant System (K140934)
• IBS Implant System (K153350)
• OSSTEM Implant System – Abutment (K161689)
• Osstem Abutment System (K182091)
• ZENEX Implant System (K211090)
• URIS OMNI System (K172100)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Ossvis Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K223924

Trade/Device Name: LW Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 5, 2023 Received: July 5, 2023

Dear April 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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542 of the Act); 21 CFR 1000-1050.

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-

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 mediation-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) K223924

Device Name LW Implant System

#### Indications for Use (Describe)

The LW Implant System is indicated for use in partially or fully edentulous mandbles and maxillae, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The LW Implant System is dedicated for two stage surgical procedures and is intended for delayed loading. Also, implants with diameters larger than 5mm are indicated for molar regions.

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

| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(K) Summary

#### Submitter

Ossvis Co., Ltd. Young Jae Kim 7F and B1. 38. Burim-ro 170beon-gil. Dongan-gu. Anyang-si, Gyeonggi-do, Republic of Korea Email: [e-mail] Tel. [phone] Fax. [phone]

# Device Information

- Trade Name: LW 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
- Date Prepared: 08/08/2023

#### Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

#### Primary Predicate

- K181138, IS-III active System by Neobiotech Co., Ltd. ●
#### Reference Device

- K153639, OneQ-SL s-Clean Implant System by Dentis Co., Ltd.
- K140091, Xpeed AnyRidge Internal Implant System by MegaGen Implant Co., Ltd. ●
- K140934, HIOSSEN Implant System by HiOSSEN Inc.
- K153350, IBS Implant System by Innobiosurg Co., Ltd.
- K161689, OSSTEM Implant System – Abutment by OSSTEM Implant Co., Ltd.
- K182091, Osstem Abutment System by OSSTEM Implant Co., Ltd.
- K211090, ZENEX Implant System by Izenimplant Co., Ltd.
- K172100, URIS OMNI System by TruAbutment Inc. ●

#### Indication for Use:

The LW 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 bridgework. The LW Implant System is dedicated for two stage surgical procedures and is intended for delayed loading. Also, implants with diameters larger than 5mm are indicated for molar regions.

# Official Correspondent

Withus Group Inc. April Lee 106 Superior. Irvine, CA 92620 USA Email: [e-mail] Phone: [phone] Fax: [phone]

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# Device Description:

The LW Implant System consists of a fixture, cover screw, healing abutments, and abutment screw.

The Fixture is made of CP Ti Grade 4(ASTM F67) with the surface treated by the SLA method. It has several design characteristics: internal hex connection, submerged type, tapered body, sided cutting edge. The Cover Screw and Healing Abutment are made of CP Ti Grade 4(ASTM F67) without any surface treatment.

The Abutments consist of the LW Solid, LW Angled, LW Vis and LW Temporary Abutment, and LW Abutment Screw. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136).

| Name | Uses | Surface Treatment | Fixture<br>Connection |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------------------------------------------------|
| LW Cover Screw | The Cover Screw is used for protecting the inner<br>hole of a fixture during the healing period. | N/A | |
| LW Healing<br>Abutment | The Healing Abutment is used for protecting<br>inner hole of a fixture and adjusting the<br>appropriate gingival shape during the healing<br>period | N/A | Non-Hex |
| LW Solid Abutment<br>LW Angled<br>Abutment<br>LW Vis Abutment | The Abutment is used as a support of prosthesis<br>to restore the patient's chewing function. | N/A | Non-Hex<br>Hex 2.48<br>/ Non-Hex<br>Hex 2.48<br>/ Non-Hex |
| LW Temporary<br>Abutment | The Temporary Abutment is used temporarily<br>until making the final prosthesis to immediately<br>restore a patient's chewing function after<br>implantation as well as maintain an esthetic<br>appearance. Maximum duration of Temporary<br>Abutment is less than 6 months. | N/A | Hex 2.48<br>/ Non-Hex |
| LW Abutment Screw | The Abutment Screw is used for connect fixture<br>and abutment | N/A | Non-Hex |

The LW Fixture, LW Cover Screw and LW Healing Abutment are provided sterile. The LW Solid Abutment, LW Angled Abutment, LW Vis Abutment, LW Temporary Abutment and LW Abutment Screw are provided non-sterile, which are required to be sterilized by the end-user before use.

| No | Device Name | Dimension |
|----|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | LW Fixture | Ø 4.2 x 7.0, 8.5, 10.0, 11.5, 13.0, 15.0 mm (L)<br>Ø 4.55 x 10.0, 11.5, 13.0, 15.0 mm (L)<br>Ø 4.60 x 7.0, 8.5 mm (L)<br>Ø 5.00 x 10.0, 11.5, 13.0, 15.0 mm (L)<br>Ø 5.05 x 8.5 mm (L)<br>Ø 5.07 x 7.0 mm (L)<br>Ø 5.40 x 10.0, 11.5, 13.0, 15.0 mm (L)<br>Ø 5.45 x 7.0, 8.5 mm (L)<br>Ø 5.90 x 9.5, 11.0, 12.5 mm (L)<br>Ø 5.95 x 7.0, 8.0 mm (L)<br>Ø 6.55 x 9.5, 11.0, 12.5 mm (L) |

The dimensions of subject devices are as following:

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| | | Ø 6.60 x 7.0, 8.0 mm (L)<br>Ø 6.80 x 9.5, 11.0, 12.5 mm (L)<br>Ø 6.85 x 7.0, 8.0 mm (L)<br>Ø 7.25 x 11.0, 12.5 mm (L)<br>Ø 7.30 x 9.5 mm (L)<br>Ø 7.35 x 7.0, 8.0 mm (L)<br>Ø 7.75 x 11.0, 12.5 mm (L)<br>Ø 7.80 x 9.5 mm (L)<br>Ø 7.85 x 7.0, 8.0 mm (L) |
|---|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | LW Cover Screw | Ø 3.6 (D) x 5.9 mm (H)<br>Ø 3.75 (D) x 6.9 mm (H)<br>Ø 3.9 (D) x 7.5 mm (H) |
| 3 | LW Healing Abutment | Ø 4.3, 4.8, 4.9, 5.3, 5.8, 6.3, 6.8, 7.3, 7.8, 8.3 (D)<br>x 2.9 / 3.9 / 4.9 / 5.9 / 6.9 / 7.9 / 8.9<br>3.0 / 4.0 / 5.0 / 6.0 / 7.0 / 8.0 / 9.0 mm (H) |
| 4 | LW Solid Abutment | Ø 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 (D)<br>x 1.0, 2.0, 3.0, 4.0, 5.0 (G/H)<br>x 4.0, 5.5, 7.0 mm (Post/H) |
| 5 | LW Angled Abutment | 15, 17, 25, 30° (Angle)<br>Ø 4.5, 5.0, 6.0 (D) x 2.0, 4.0 mm (G/H) |
| 6 | LW Vis Abutment | Ø 4.5, 4.6, 5.0, 6.0, 7.0 (D)<br>x 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 mm (G/H)<br>x 4.0, 5.5, 7.0 (Post/H) |
| 7 | LW Temporary<br>Abutment | Ø 4.5 (D)<br>x 1.0, 3.0 mm (G/H)<br>x 10 mm (Post/H) |
| 8 | LW Abutment Screw | Ø 2.3 (D) x 8.34 mm (L) |

# Materials:

- The LW fixtures, Healing Abutment, and Cover Screw are fabricated from Pure titanium of ASTM . F67
- LW abutments are fabricated from Ti-6Al-4V of ASTM F136 ●

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# Summaries of Technological Characteristics & Substantial Equivalence Discussion

# LW Fixture

| | Subject Device | Primary Predicate | Reference Device | Reference Device |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | N/A | K181138 | K153639 | K140091 |
| Device Name | LW Implant System | IS-III active System | OneQ-SL s Clean Implant System | Xpeed AnyRidge Internal Implant<br>System |
| Manufacturer | Ossvis Co., Ltd. | Neobiotech Co., Ltd. | Dentis Co., Ltd. | MegaGen Implant Co., Ltd. |
| Product Code | DZE | DZE | DZE | DZE |
| Regulation | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 |
| Appearance | | | | |
| Indications for<br>Use Statement | The LW Implant System is<br>indicated for use in partially or<br>fully edentulous mandibles and<br>maxillae, in support of single or<br>multiple-unit restorations including;<br>cemented retained, screw retained,<br>or overdenture restorations, and<br>terminal or intermediate abutment<br>support for fixed bridgework. The<br>LW Implant System is dedicated for<br>two stage surgical procedures and is<br>intended for delayed loading. Also,<br>implants with diameters larger than<br>5mm are indicated for molar<br>regions. | The IS-III active System is<br>indicated for use in partially or<br>fully edentulous mandibles and<br>maxillae, in support of single or<br>multiple-unit restorations<br>including; cemented retained,<br>screw retained, or overdenture<br>restorations, and terminal or<br>intermediate abutment support for<br>fixed bridgework. IS-III active<br>System is dedicated for two stage<br>surgical procedures and for<br>immediate loading when there is<br>good primary stability and an<br>appropriate occlusal load. Also,<br>implants with diameters larger<br>than 5mm are indicated for molar<br>regions. | The OneQ-SL s Clean Implant<br>System is indicated for use in<br>partially or fully edentulous<br>mandibles and maxillae, in<br>support of single or multiple-unit<br>restorations including; cemented<br>retained, screw retained, or<br>overdenture restorations, and<br>terminal or intermediate abutment<br>support for fixed bridgework. This<br>system is dedicated for one and<br>two stage surgical procedures.<br>This system is intended for<br>delayed loading. | The product is intended to be<br>surgically placed in the maxillary<br>or mandibular molar areas for the<br>purpose providing prosthetic<br>support for dental restorations<br>(Crown, bridges, and<br>overdentures) in partially of fully<br>edentulous individuals.<br>It is used to restore a patient's<br>chewing function. Smaller<br>implants (less than 6.0mm) are<br>dedicated for immediate loading<br>when good primary stability is<br>achieved and with appropriate<br>occlusal loading. Larger implants<br>are dedicated for the molar region<br>and are indicated for delayed<br>loading. |
| Structure | • Internal Hex Connection<br>• Submerged Fixture<br>• Tapered & Straight body shape<br>• sided cutting edge with self<br>tapping | • Internal Hex Connection<br>• Submerged Fixture<br>• Tapered & Straight body shape<br>• sided cutting edge with self-<br>tapping | • Internal Hex Connection<br>• Submerged Fixture<br>• Tapered & Straight body shape<br>• sided cutting edge with self-<br>tapping | • Internal Hex Connection<br>• Submerged Fixture<br>• Tapered & Straight body shape |
| Diameter (Ø) | 4.2, 4.55, 4.6, 5.0, 5.05, 5.07, 5.4,<br>5.45, 5.9, 5.95, 6.55, 6.6, 6.8, 6.85,<br>7.25, 7.3 7.35, 7.75, 7.8, 7.85 | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular: 3.7, 3.9, 4.2, 4.7, 5.2<br>Wide: 6.0, 7.0, 8.0 | 4.0, 4.4, 4.9, 5.4, 5.9<br>(For normal ridge)<br>6.4, 6.9, 7.4, 7.9, 8.4<br>(For low ridge) |
| Length (mm) | 7.0, 8.0, 8.5, 9.5, 10.0, 11.0,<br>11.5, 12.5, 13.0, 15.0 | 8.5, 10.0, 11.5, 13.0, 15.0<br>(For a diameter of 3.5) | Regular: 7.0, 8.0, 10.0, 12.0, 14.0<br>Wide: 7.0, 8.0, 10.0, 12.0 | 7.7, 9.2, 10.7, 12.2, 14.2, 17.2<br>(For normal ridge) |
| | (For diameters of 4.2 – 5.45)<br>7.0, 8.0, 8.5, 9.5, 10.0, 11.0,<br>11.5, 12.5<br>(For diameters of 5.9 – 7.85) | 7.3, 8.5, 10.0, 11.5, 13.0, 15.0<br>(For a diameter of 4.0 – 5.5)<br>7.3, 8.5, 10.0, 11.5, 13.0<br>(For a diameter of 6.0 – 7.0) | | 7.9, 9.4, 10.9, 12.4, 14.4<br>(For low ridge) |
| Material | Pure Titanium Grade 4<br>(ASTM F67) | Pure Titanium Grade 4<br>(ASTM F67) | Pure Titanium Grade 4<br>(ASTM F67) | Pure Titanium Grade 4<br>(ASTM F67) |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Surface treatment | SLA | SLA | SLA | SLA |
| Substantial Equivalence Discussion | | | | |
| The LW Fixture has the same indication for use, material, design feature, structure, surface treatment, and sterilization as the primary predicate. The difference between | | | | |

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the subject and primary predicate, K181138 is dimensions. The predicate device does not include all dimensional combinations of the such as the fixture with diameter 4.2 x length 7.0 mm and fixtures with 1.0mm. However, the difference is covered by the reference is covered by the reference devices such as K 15639 and K 14091 which have a wider range of diament and issue in performance or safety. Therefore, it is substantialy equivalent.

#### LW Cover Screw

| | Subject Device | Reference Predicate | Reference Device |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|---------------------------------------|-------------------------------------|
| 510(k) # | N/A | K153639 | K140934 |
| Device Name | LW Implant System | OneQ-SL s-Clean Implant System | HIOSSEN Implant System |
| Manufacturer | Ossvis Co., Ltd. | Dentis Co., Ltd. | HIOSSEN Inc. |
| Product Code | NHA | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: Subject Device Appearance | Image: Reference Predicate Appearance | Image: Reference Device Appearance |
| Diameter (Ø) | 3.6, 3.75, 3.9 | 3.6 | 3.03, 3.58, 3.25, 3.4, 3.75, 3.9 |
| Height (mm) | 5.9, 6.9, 7.5 | 5.9 | 5.25, 5.9, 6.25, 6.85, 6.9, 7.5 |
| Material | Pure Titanium Grade 4<br>(ASTM F67) | Pure Titanium Grade 4<br>(ASTM F67) | Pure Titanium Grade 4<br>(ASTM F67) |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Surface treatment | N/A | N/A | Anodizing |
| Substantial Equivalence Discussion | | | |
| The LW Cover Screw has the same indications for use, material, sterilization, and similar design as the primary predicate. The difference between | | | |
| subject and primary predicate is dimension. The subject device has a wider range of diameters and lengths. The reference device, K140934 was added since it | | | |
| encompasses the dimension range of the subject device and supports substantial equivalence. | | | |

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#### LW Healing Abutment

| | Subject Device | Reference Device | Reference Device |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|------------------------------------------|----------------------------------------|
| 510(k) # | N/A | K140934 | K211090 |
| Device Name | LW Implant System | HIOSSEN Implant System | ZENEX Implant System |
| Manufacturer | Ossvis Co., Ltd. | HiOSSEN Inc. | Izenimplant Co., Ltd. |
| Product Code | NHA | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: LW Implant System Appearance | Image: HIOSSEN Implant System Appearance | Image: ZENEX Implant System Appearance |
| Diameter (Ø) | 4.3, 4.8, 4.9, 5.3, 5.8, 6.3, 6.8, 7.3, 7.8, 8.3 | 4.3, 4.8, 5.3, 6.3, 7.3 | 4.3 ~ 9.0 |
| Height (mm) | 2.9 – 9.0 | 3.0, 4.0, 5.0, 7.0 | 2.0 ~ 9.0 |
| Material | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) | Ti 6Al 4V ELI (ASTM F136) |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Surface treatment | N/A | N/A | N/A |
| Substantial Equivalence Discussion | | | |
| The LW Healing Abutment has the same intended use, material, surface treatment, sterilization and similar design as the reference device (K140934).<br>The difference between subject and reference device, K140934 is the dimensions. The subject device has a wider range of diameters and heights. The wider range of<br>dimensions is intended to meet the needs of each patient and does not raise an issue in safety and performance of the device. The reference device (K211090). | | | |

encompasses the diameter range of the subject device and supports substantial equivalence.

#### LW Solid Abutment

| | Subject Device | Reference Device | Reference Device |
|---------------|-----------------------------------|----------------------------------|--------------------------------|
| 510(k) # | N/A | K161689 | K172100 |
| Device Name | LW Implant System | OSSTEM Implant System - Abutment | URIS OMNI System |
| Abutment Name | LW Solid Abutment | Rigid Abutment | D Basis Abutment – Direct Type |
| Manufacturer | Ossvis Co., Ltd. | OSSTEM Implant Co., Ltd. | TruAbutment Korea Co., Ltd. |
| Product Code | NHA | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: LW Solid Abutment | Image: Rigid Abutment | Image: D Basis Abutment |
| Diameter (Ø) | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 | 4.0, 4.6, 5.0, 6.0, 7.0 | 4.0, 4.5, 5.5, 6.5 |
| G/H (mm) | 1.0, 2.0, 3.0, 4.0, 5.0 | 1.0, 2.0, 3.0, 4.0, 5.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 |
| P/H (mm) | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm |

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

| Material | Ti 6Al 4V ELI<br>(ASTM F136) | Ti 6Al 4V ELI<br>(ASTM F136) | Ti 6Al 4V ELI<br>(ASTM F136) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------|------------------------------|
| Surface treatment | Non-coating | TiN-coating | Non-coating |
| <b>Substantial Equivalence Discussion</b> | | | |
| The intended use, material, sterilization, dimension, and general design of the LW Solid Abutment are same as the reference devices, K161689. The difference between<br>the two devices is surface treatment. To support this discrepancy, K172100 was added. Therefore, it is substantially equivalent. | | | |

#### LW Angled Abutment

| LW Angled Abutment | Subject Device | Reference Device | Reference Device |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-------------------------------|------------------------------|
| 510(k) # | N/A | K182091 | K153350 |
| Device Name | LW Implant System | Osstem Abutment System | IBS Implant System |
| Abutment Name | LW Angled Abutment | Angled Abutment | Angled Abutment |
| Manufacturer | Ossvis Co., Ltd. | OSSTEM Implant Co., Ltd. | Innobiosurg Co., Ltd. |
| Product Code | NHA | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: LW Angled Abutment | Image: Osstem Abutment System | Image: IBS Implant System |
| Connection Type | Hex, Non-Hex | Hex, Non-Hex | Internal Hex |
| Diameter (Ø) | 4.5, 5.0, 6.0 | 4.0, 4.5, 5.0, 6.0 | 4.0, 4.5, 5.0 |
| G/H (mm)…