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 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).

AI/ML Overview

The provided text is a 510(k) Summary for the LW Implant System. It outlines substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data for this device. Therefore, a table of acceptance criteria and direct device performance is not explicitly available in the provided text in the way one would typically find for a new, de novo device or a clinical study.

The document focuses on demonstrating that the LW Implant System is "substantially equivalent" to already legally marketed predicate devices. This means that the device meets the same safety and effectiveness standards, often by showing it performs as well as, or better than, a known predicate device.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't present specific acceptance criteria and performance data in a dedicated table for the LW Implant System, as it's a 510(k) submission focused on substantial equivalence. Instead, it describes various non-clinical tests performed to demonstrate that the device meets established standards and performs comparably to predicate devices. The "acceptance criteria" are implied by adherence to relevant ISO and ASTM standards and FDA guidance documents, and the "reported device performance" is essentially that the device "met the acceptance criteria" or "demonstrated substantial equivalence."

Here's an interpretation of the implied acceptance criteria and the summary of reported performance:

Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
Gamma Sterilization Validation	Compliance with ISO 11137-1, -2, -3 to achieve a Sterility Assurance Level (SAL) of 10-6.	Validated to achieve SAL of 10-6. Results prove equivalence to predicate device.
End-User Sterilization Validation	Compliance with ISO 17665-1, -2 and FDA guidance "Reprocessing Medical Devices in Health Care Settings".	Validated. Results showed equivalence to predicate device.
Shelf-life Test	Compliance with ASTM F1980; no degradation of device functionality over specified shelf-life.	Devices function adequately for 5 years without degradation. Demonstrated equivalence to predicate devices.
Biocompatibility Tests (Cytotoxicity)	Compliance with ISO 10993-1, -5 and FDA Guidance.	Demonstrated biocompatibility of the material used.
Fatigue Test (Dynamic Fatigue & Static Compression)	Compliance with ISO 14801:2016 and FDA guidance "Class II Special Controls Guidance Document".	Expected to function properly for intended use.
Bacterial Endotoxin Testing (LAL)	Compliance with USP <85>, USP <161>, and FDA guidance for pyrogen limit specifications.	Met acceptance criteria. Demonstrated substantial equivalence with the predicate device.
Surface Treatment Evaluation (SLA)	Compliance with 'Section 11 of Class II Special Controls Guidance Document'; comparable surface roughness, composition, and SEM imaging to predicate.	Demonstrated substantial equivalence through surface roughness, composition analysis, SEM imaging, and ICP analysis.
MRI Safety Review	Compliance with FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" for magnetically induced displacement force and torque.	Performed using scientific rationale and published literature; rationale addressed parameters.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the specific sample sizes for each non-clinical test performed (e.g., how many devices were subjected to fatigue testing, or how many samples for biocompatibility). It references standards like ISO and ASTM, which inherently define sample size requirements, but the exact numbers are not reported in this summary.

Data Provenance: The tests are non-clinical (laboratory-based) and were conducted to support the safety and performance of the device against established standards and predicate device comparisons. The "country of origin of the data" is not explicitly stated for each test, but the applicant, Ossvis Co., Ltd., is based in the Republic of Korea. The data is retrospective in the sense that the tests were completed before this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to the provided document. The "ground truth" in this context is established through adherence to recognized international standards (ISO, ASTM) and national regulations (FDA guidance documents). These standards typically involve scientific and engineering principles, and the "experts" are the scientific and engineering professionals who developed these standards and those who conducted the tests in accordance with them. There is no mention of a ground truth established by a panel of clinical experts for a test set in a diagnostic or clinical performance study for this device.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of results by multiple readers (e.g., radiologists, pathologists) to establish a consensus ground truth. Since the reported studies are non-clinical performance and safety tests, a human adjudication method is not used. The "adjudication" is essentially the determination of whether the device passed the specified test according to the defined acceptance criteria in the relevant standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical performance and safety to demonstrate substantial equivalence, not on the comparative effectiveness of human readers with or without AI assistance. This device is a physical dental implant system, not an AI/software as a medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, this is not applicable. This device is a physical medical device (dental implant system), not an algorithm or software. The concept of "standalone performance" without human-in-the-loop is relevant to AI/software applications, not to this type of medical device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established scientific and engineering standards and regulatory guidance limits. For example:

Sterility: Defined by ISO 11137 with an SAL of 10-6.
Biocompatibility: Defined by ISO 10993 standards.
Fatigue: Defined by ISO 14801.
Bacterial Endotoxin: Defined by USP <85> and <161>.
Surface Characteristics: Defined by FDA special controls guidance for dental implants.

The comparison is also made against the performance and characteristics of legally marketed predicate devices, implying that their established safety and effectiveness serve as a practical "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The LW Implant System is a physical medical device. The concept of a "training set" typically applies to machine learning algorithms where data is used to train a model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no "training set" for this physical medical device.

Summary

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

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.

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) Summary

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: yjk@ossvis.com Tel. +82-31-360-0082 Fax. +82-31-360-0058

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:

Official Correspondent

Withus Group Inc. April Lee 106 Superior. Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

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

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	FixtureConnection
LW Cover Screw	The Cover Screw is used for protecting the innerhole of a fixture during the healing period.	N/A
LW HealingAbutment	The Healing Abutment is used for protectinginner hole of a fixture and adjusting theappropriate gingival shape during the healingperiod	N/A	Non-Hex
LW Solid AbutmentLW AngledAbutmentLW Vis Abutment	The Abutment is used as a support of prosthesisto restore the patient's chewing function.	N/A	Non-HexHex 2.48/ Non-HexHex 2.48/ Non-Hex
LW TemporaryAbutment	The Temporary Abutment is used temporarilyuntil making the final prosthesis to immediatelyrestore a patient's chewing function afterimplantation as well as maintain an estheticappearance. Maximum duration of TemporaryAbutment is less than 6 months.	N/A	Hex 2.48/ Non-Hex
LW Abutment Screw	The Abutment Screw is used for connect fixtureand 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)Ø 4.55 x 10.0, 11.5, 13.0, 15.0 mm (L)Ø 4.60 x 7.0, 8.5 mm (L)Ø 5.00 x 10.0, 11.5, 13.0, 15.0 mm (L)Ø 5.05 x 8.5 mm (L)Ø 5.07 x 7.0 mm (L)Ø 5.40 x 10.0, 11.5, 13.0, 15.0 mm (L)Ø 5.45 x 7.0, 8.5 mm (L)Ø 5.90 x 9.5, 11.0, 12.5 mm (L)Ø 5.95 x 7.0, 8.0 mm (L)Ø 6.55 x 9.5, 11.0, 12.5 mm (L)

The dimensions of subject devices are as following:

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

		Ø 6.60 x 7.0, 8.0 mm (L)Ø 6.80 x 9.5, 11.0, 12.5 mm (L)Ø 6.85 x 7.0, 8.0 mm (L)Ø 7.25 x 11.0, 12.5 mm (L)Ø 7.30 x 9.5 mm (L)Ø 7.35 x 7.0, 8.0 mm (L)Ø 7.75 x 11.0, 12.5 mm (L)Ø 7.80 x 9.5 mm (L)Ø 7.85 x 7.0, 8.0 mm (L)
2	LW Cover Screw	Ø 3.6 (D) x 5.9 mm (H)Ø 3.75 (D) x 6.9 mm (H)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)x 2.9 / 3.9 / 4.9 / 5.9 / 6.9 / 7.9 / 8.93.0 / 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)x 1.0, 2.0, 3.0, 4.0, 5.0 (G/H)x 4.0, 5.5, 7.0 mm (Post/H)
5	LW Angled Abutment	15, 17, 25, 30° (Angle)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)x 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 mm (G/H)x 4.0, 5.5, 7.0 (Post/H)
7	LW TemporaryAbutment	Ø 4.5 (D)x 1.0, 3.0 mm (G/H)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 ●

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

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 ImplantSystem
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 forUse Statement	The LW Implant System isindicated for use in partially orfully edentulous mandibles andmaxillae, in support of single ormultiple-unit restorations including;cemented retained, screw retained,or overdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework. TheLW Implant System is dedicated fortwo stage surgical procedures and isintended for delayed loading. Also,implants with diameters larger than5mm are indicated for molarregions.	The IS-III active System isindicated for use in partially orfully edentulous mandibles andmaxillae, in support of single ormultiple-unit restorationsincluding; cemented retained,screw retained, or overdenturerestorations, and terminal orintermediate abutment support forfixed bridgework. IS-III activeSystem is dedicated for two stagesurgical procedures and forimmediate loading when there isgood primary stability and anappropriate occlusal load. Also,implants with diameters largerthan 5mm are indicated for molarregions.	The OneQ-SL s Clean ImplantSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single or multiple-unitrestorations including; cementedretained, screw retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework. Thissystem is dedicated for one andtwo stage surgical procedures.This system is intended fordelayed loading.	The product is intended to besurgically placed in the maxillaryor mandibular molar areas for thepurpose providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially of fullyedentulous individuals.It is used to restore a patient'schewing function. Smallerimplants (less than 6.0mm) arededicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implantsare dedicated for the molar regionand are indicated for delayedloading.
Structure	• Internal Hex Connection• Submerged Fixture• Tapered & Straight body shape• sided cutting edge with selftapping	• Internal Hex Connection• Submerged Fixture• Tapered & Straight body shape• sided cutting edge with self-tapping	• Internal Hex Connection• Submerged Fixture• Tapered & Straight body shape• sided cutting edge with self-tapping	• Internal Hex Connection• Submerged Fixture• Tapered & Straight body shape
Diameter (Ø)	4.2, 4.55, 4.6, 5.0, 5.05, 5.07, 5.4,5.45, 5.9, 5.95, 6.55, 6.6, 6.8, 6.85,7.25, 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, 5.2Wide: 6.0, 7.0, 8.0	4.0, 4.4, 4.9, 5.4, 5.9(For normal ridge)6.4, 6.9, 7.4, 7.9, 8.4(For low ridge)
Length (mm)	7.0, 8.0, 8.5, 9.5, 10.0, 11.0,11.5, 12.5, 13.0, 15.0	8.5, 10.0, 11.5, 13.0, 15.0(For a diameter of 3.5)	Regular: 7.0, 8.0, 10.0, 12.0, 14.0Wide: 7.0, 8.0, 10.0, 12.0	7.7, 9.2, 10.7, 12.2, 14.2, 17.2(For normal ridge)
	(For diameters of 4.2 – 5.45)7.0, 8.0, 8.5, 9.5, 10.0, 11.0,11.5, 12.5(For diameters of 5.9 – 7.85)	7.3, 8.5, 10.0, 11.5, 13.0, 15.0(For a diameter of 4.0 – 5.5)7.3, 8.5, 10.0, 11.5, 13.0(For a diameter of 6.0 – 7.0)		7.9, 9.4, 10.9, 12.4, 14.4(For low ridge)
Material	Pure Titanium Grade 4(ASTM F67)	Pure Titanium Grade 4(ASTM F67)	Pure Titanium Grade 4(ASTM F67)	Pure Titanium Grade 4(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

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

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(ASTM F67)	Pure Titanium Grade 4(ASTM F67)	Pure Titanium Grade 4(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.

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

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).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 ofdimensions 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(ASTM F136)	Ti 6Al 4V ELI(ASTM F136)	Ti 6Al 4V ELI(ASTM F136)
Surface treatment	Non-coating	TiN-coating	Non-coating
Substantial Equivalence Discussion
The intended use, material, sterilization, dimension, and general design of the LW Solid Abutment are same as the reference devices, K161689. The difference betweenthe 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)	2.0, 4.0	2.0, 4.0	1.0, 2.0, 3.0, 4.0
P/H (mm)	8.0	8.0	1.0, 2.0, 3.0, 4.0
Angle (°)	15, 17, 25, 30°	17°	15, 25, 30°
Material	Ti 6Al 4V ELI(ASTM F136)	Ti 6Al 4V ELI(ASTM F136)	Ti 6Al 4V ELI(ASTM F136)
Surface treatment	Non-coating	TiN-coating	Non-coating
Substantial Equivalence Discussion
The LW Angled Abutment has the same intended use, material, sterilization, and similar design as the reference devices, K182091. The difference between the two

devices is angulation and surface treatment.

To support angulation and surface treatment, K153350 was added. Therefore, it is substantially equivalent.

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

LW Vis Abutment

	Subject Device	Reference Device	Reference Device
510(k) Number	N/A	K182091	K172100
Device Name	LW Implant System	Osstem Abutment System	URIS OMNI System
Abutment Name	LW Vis Abutment	Transfer Abutment	D Basis Abutment – Cemented Type
Manufacturer	Ossvis Co., Ltd.	OSSTEM Implant Co., Ltd.	TruAbutment Korea Co., Ltd.
Product Code	NHA	NHA	NHA
Regulation Number	872.3630	872.3630	21 CFR 872.3630
Appearance	Image: LW Vis Abutment	Image: Transfer Abutment	Image: D Basis Abutment
Connection Type	Hex, Non-Hex	Hex, Non-Hex	Hex, Non-Hex
Diameter (Ø)	4.5, 4.6, 5.0, 6.0, 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, 6.0, 7.0	1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0	1.0, 2.0, 3.0, 4.0, 5.0, 6.0
P/H (mm)	4.0, 5.5, 7.0	4.0, 5.5, 7.0	4.0, 5.5, 7.0 mm
Material	Ti 6Al 4V ELI (ASTM F136)	Ti 6Al 4V ELI(ASTM F136)	Ti 6Al 4V ELI(ASTM F136)
Surface treatment	Non-coating	TiN-coating	Non-coating
Substantial Equivalence Discussion
The intended use, material, sterilization, dimension, and general design of the LW Solid Abutment are same as the reference devices, K182091. The differencebetween the two devices is surface treatment. To support this discrepancy, K172100 was added. Therefore, it is substantially equivalent.

LW Temporary Abutment

	Subject Device	Reference Device
510(k) #	N/A	K161689
Device Name	LW Implant System	OSSTEM Implant System - Abutment
Abutment Name	LW Temporary Abutment	Temporary Abutment
Manufacturer	Ossvis Co., Ltd.	OSSTEM Implant Co., Ltd.
Product Code	NHA	NHA
Regulation	21 CFR 872.3630	21 CFR 872.3630
Appearance	Image: Subject Device Appearance	Image: Reference Device Appearance
Connection Type	Hex, Non-Hex	Hex, Non-Hex
Diameter (Ø)	4.5	4.0, 4.5
G/H (mm)	1.0, 3.0	1.0, 3.0
Post/H (mm)	10	10

{11}------------------------------------------------

Material	Ti 6Al 4V ELI (ASTM F136)	Ti 6Al 4V ELI (ASTM F136)
Maximum duration	Less than 6 months	Less than 6 months
Surface treatment	N/A	N/A
Substantial Equivalence Discussion
The LW Temporary Abutment has the same intended use, surface treatment, sterilization, fixture connection type and similar design as the reference device,K161689. Although the post shape differs from the reference device, we do not consider the differences between devices a serious thing that affect the safety andeffectiveness of the device since the device is temporarily used in the human body unlike other permanent abutments. Therefore, it is substantially equivalent.

LW Abutment Screw

	Subject Device	Reference Device
510(k) #	N/A	K161689
Device Name	LW Implant System	OSSTEM Implant System - Abutment
Abutment Name	LW Abutment Screw	Abutment Screw
Manufacturer	Ossvis Co., Ltd.	OSSTEM Implant Co., Ltd.
Product Code	NHA	NHA
Regulation	21 CFR 872.3630	21 CFR 872.3630
Appearance	Image: LW Abutment Screw	Image: Abutment Screw
Diameter (Ø)	2.3 mm	2.0, 2.05, 2.2, 2.3, 2.5 mm
Length (mm)	8.34mm	3.35, 5.6, 7.5, 8.35, 9.6, 10.2 mm
Material	Ti 6Al 4V ELI(ASTM F136)	Ti 6Al 4V ELI(ASTM F136)
Surface treatment	N/A	N/A
Substantial Equivalence Discussion
The LW Abutment Screw has the identical to the reference device, K161689 in intended use, design, material, and surface treatment. Device comparison shows theequivalence between the subject and predicate device.

{12}------------------------------------------------

Non-Clinical Test Data

The following non-clinical tests were conducted on the subject devices to prove the safety and performance:

Gamma Sterilization Validation Test under ISO 11137-1, ISO 11137-2, and ISO 11137-3
End User sterilization Validation under ISO 17665-1 and ISO 17665-2
. Shelf-life Test under ASTM F1980
. Biocompatibility Tests - cytotoxicity according to ISO 10993-5
. Fatigue test under ISO 14801
Bacterial Endotoxin Testing (LAL) under USP <85>, and USP <161>

The surface treatment evaluation has been performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'. The surface modification with SLA (sand-blasted, large-grit, acid-etched) was provided. To compare surface modification between the subject and predicate device (K181138), surface roughness, surface composition analysis, SEM imaging, and ICP analysis were provided, and it demonstrates substantial equivalence.

For devices delivered sterile such as Fixture, Healing Abutment, and Cover Screw, a sterility assurance level (SAL) of 10° have been validated in accordance with ISO 11137-1:2006 "Sterilization of health care products - Radiation - Part 1: Requirement, for development, validation and routine control of a sterilization process for medical devices". The validation took into account the worst-case scenario, and the results prove equivalence to the predicate device.

For devices delivered non-sterilized, the recommended sterilization condition has been validated through the end-user sterilization, according to ISO 17665-1 "Sterilization of health care products - Moist heat - part 1: Requirement, validation, and routine control of a sterilization process for medical devices", ISO 17665-2 "Sterilization of health care products -Moist heat - part 2: Guidance on the application of ISO 17665-1", and to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The worst-case scenario had been considered in the validation, and the results showed equivalence to the predicate device.

Shelf-life Testing was performed on the devices provided sterile in accordance with ASTM F1980 "Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices". The worst-case scenario was tested, and the results demonstrated that the devices are equivalent to the predicate devices. The shelf-life for the Fixture, Healing Abutment, and Cover Screw is 5 years, and the devices will function adequately as intended without any degradation during the shelf-life. Please note that the devices will not be labeled as 'non-pyrogenic' when they are marketed.

Biocompatibility Testing was performed according to ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and to the FDA Guidance document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff". Cytotoxicity testing was performed according to ISO 10993-5. The result demonstrated the biocompatibility of the material used.

To evaluate the performance of subject devices, Dynamic Fatigue and Static Compression Strength tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental

{13}------------------------------------------------

Abutments" and ISO 14801:2016, "Dentistry - Implants - Dynamic fatigue test for endosseous dental implants" under the worst-case scenario. As a result, our dental implant system is expected to function properly for its intended use, which is to replace the patient's natural tooth and restore chewing function.

To address the presence of bacterial endotoxins, the devices corresponding to implants should meet the pyrogen limit specifications as specified in the FDA guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" and USP <161> "Medical Devices – Bacterial Endotoxin and Pyrogen Tests". Therefore, our dental implant fixtures were tested for bacterial endotoxin under USP <85> "Bacterial Endotoxins Test", and USP <161> "Medical Devices – Bacterial Endotoxin and Pyrogen Tests". The test result have met the acceptance criteria and demonstrated the substantial equivalence with the predicate device.

Non-clinical worst-case MRI review was performed to evaluate the subject 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 4 9.2 (2 01 9): 7 8 3-795), based on the entire system including all fixtures and abutments 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.

The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.

Conclusion

The documentation submitted in this premarket notification demonstrates the LW Implant System is substantially equivalent to the primary predicate and reference devices.

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.