STERI-OSS Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. STERI-OSS Implant System is for single stage surgical procedures. This system is intended for delayed loading.

Device Description

STERI-OSS Implant System, Fixture is a medical device made of titanium that is inserted into the maxillary or mandibular alveolar bone to support prosthesis such as artificial teeth for the patient's recovery of masticatory function.
STERI-OSS Implant System. Abutment is inserted to support prosthesis such as artificial teeth, and is a medical device made of titanium alloy. It connects artificial teeth with a fixture implanted in the maxillary or mandibular alveolar bone where teeth are lost.

AI/ML Overview

The provided document is a 510(k) summary for the STERI-OSS Implant System, which is a dental implant system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study where the device meets pre-defined acceptance criteria for performance in a clinical setting. For medical devices undergoing 510(k) clearance, the primary goal is to show that the new device is as safe and effective as a legally marketed predicate device, not necessarily to meet specific novel performance acceptance criteria through clinical studies.

Therefore, the requested information elements such as "acceptance criteria and the reported device performance," "sample sizes used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how ground truth for the training set was established" are typically not applicable in the context of a 510(k) substantial equivalence submission for a device like a dental implant. These elements are more commonly associated with clinical trials or performance studies for novel devices or software with AI/ML components requiring new clinical evidence.

The document describes non-clinical testing to demonstrate that the differences between the subject device and predicate devices do not affect substantial equivalence.

Here's a breakdown of the available and non-applicable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not applicable in the format typically used for performance studies with defined acceptance criteria for clinical outcomes. The document instead presents a comparison of technological characteristics with predicate devices and reports on non-clinical engineering and materials testing to support substantial equivalence.

Item	Acceptance Criteria (Not explicitly defined for clinical performance)	Reported Device Performance (as per non-clinical testing)
Fixture	- Material: Pure Titanium Grade 4 (ASTM F67)	Matches predicate/reference devices
	- Connection type: Internal Hex	Matches predicate/reference devices
	- Surface Treatment: SLA	Matches predicate/reference devices
	- Sterilization: Gamma Sterilization	Matches predicate/reference devices
	- Dimensions: Within similar dimensional range of predicates	Demonstrated to be similar or within range
Abutment	- Material: Ti6Al4V ELI (ASTM F136)	Matches reference devices
(Straight Abutment)	- Principle of operation: Cement retained restoration	Matches reference devices
	- Surface Treatment: None (machined surface)	Matches some reference devices; difference with TiN-coated predicate deemed minor
	- Dimensions: Similar design and dimension range	Demonstrated to be similar or within range
Abutment	- Material: Ti6Al4V ELI (ASTM F136)	Matches reference devices
(Solid Abutment)	- Principle of operation: Cement retained restoration	Matches reference devices
	- Surface Treatment: None (machined surface)	Matches some reference devices; difference with TiN-coated predicate deemed minor
	- Dimensions: Similar design and dimension range	Demonstrated to be similar or within range
Abutment	- Material: Ti6Al4V ELI (ASTM F136)	Matches reference devices
(Angled Abutment)	- Principle of operation: Cement retained restoration	Matches reference devices
	- Surface Treatment: None (machined surface)	Matches some reference devices; difference with TiN-coated predicate deemed minor
	- Dimensions: Similar design and dimension range	Demonstrated to be similar or within range, supported by mechanical bench testing for differences
Screw	- Material: Ti6Al4V ELI (ASTM F136)	Matches reference devices; difference with cp-Ti predicate deemed minor
(Abutment Screw)	- Principle of operation: Connect abutment to fixture	Matches reference devices
	- Surface Treatment: None	Matches reference devices
	- Dimensions: Within reference device dimensions	Demonstrated to be within range
Screw	- Material: Ti6Al4V ELI (ASTM F136)	Matches some reference devices; difference with cp-Ti predicate deemed minor
(Cover Screw)	- Principle of operation: Protect internal portion of implant	Matches reference devices
	- Surface Treatment: None	Matches some reference devices; difference with anodized predicate deemed minor
	- Dimensions: Within range of reference device dimensions	Demonstrated to be within range
Abutment	- Material: Ti6Al4V ELI (ASTM F136)	Matches some reference devices; difference with cp-Ti predicate deemed minor
(Healing Abutment)	- Principle of operation: Help soft tissue of gum naturally formed	Matches reference devices
	- Surface Treatment: None	Matches some reference devices; difference with anodized predicate deemed minor
	- Dimensions: Similar design and dimension range	Demonstrated to be similar or within range
General Non-Clinical	- ISO 14801:2016 (Fatigue)	Successfully tested for worst-case scenario
	- ISO 11137-1/2 (Gamma Sterilization)	Validated
	- ANSI/AAMI ST79, ISO 17665-1/2, ISO 11737-1/2, ISO 11138-1/3 (End User Sterilization)	Validated
	- ASTM F88, F1140, F1929, F2096 (Shelf Life)	Tested (5 years)
	- ISO 10993-1/5/12 (Biocompatibility)	Evaluated and tested
	- USP <85> (Pyrogen and Endotoxin)	Endotoxin testing conducted per batch (limit < 0.5 EU/mL)
	- FDA Guidance ("Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment") (MR Compatibility)	Non-clinical worst-case MRI review performed

2. Sample size used for the test set and the data provenance:

This information is not applicable as the document describes non-clinical engineering and material testing rather than clinical trials with patient data. The "test set" would refer to the physical devices or materials used for the non-clinical tests (e.g., fatigue testing samples, sterilization samples), but specific sample sizes for these are not detailed in this summary for each test, only that they were conducted according to specified standards.

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. Ground truth is not established by experts in the context of this 510(k) submission, as it focuses on demonstrating substantial equivalence through non-clinical testing of materials, design, and manufacturing processes, rather than diagnostic accuracy or clinical outcomes.

4. Adjudication method for the test set:

This information is not applicable. No adjudication method is described because there is no "test set" in the context of human interpretation or diagnostic agreement.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. An MRMC comparative effectiveness study is relevant for AI-powered diagnostic devices, which is not the nature of the STERI-OSS Implant System (a dental implant).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The STERI-OSS Implant System is a physical medical device, not an algorithm or AI software. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used:

This information is not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for this submission focuses on adherence to engineering standards, material specifications, and comparative characteristics with predicate devices. For example, for biocompatibility, the "ground truth" is established by the specified ISO standards for biological evaluation. For fatigue, it's defined by the ISO standard for endosseous dental implants.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not an AI/ML device requiring machine learning model training.

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as point 8.

Summary

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

Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Zeros Co., Ltd. Uk Joo CTO 138-13, Pyeonggang-ro 345beon-gil Gangseo-gu, Busan 46700 REPUBLIC OF KOREA

March 25, 2024

Re: K232268

Trade/Device Name: STERI-OSS Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 20, 2024 Received: February 20, 2024

Dear Uk Joo:

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 (the 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 available 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}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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

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,

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 Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K232268

Device Name STERI-OSS Implant System

Indications for Use (Describe)

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."

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

510(k) Summary

Date revised : March 24, 2024

I. SUBMITTER

Zeros Co., Ltd. 138-13, Pyeonggang-ro 345beon-gil, Gangseo-gu, Busan, 46700, Rep, of Korea TEL: +82-51-831-0094 FAX: +82-51-831-0095 Contact Name: Uk Hyon Joo Email: ecometal@nate.com

II. DEVICE INFORMATION

Device's Trade name: STERI-OSS Implant System ●
Classification Name: Implant, Endosseous, Root-Form
Device's Common Name: Endosseous Dental Implant
. Regulation Number 872.3640
. Class: 2
Primary Product Code: DZE
Secondary Product Code: NHA

III. PREDICATE DEVICE

Primary Predicate Device:

K121995, TS Fixture System, OSSTEM Implant Co., Ltd. 0
Reference Device:
K120503. CMI Implant IS II Active. Neobiotech Co., Ltd. 0
K202039, Honorst Implant System, MEDIMECCA Co., Ltd.
K182091, Osstem Abutment System, Osstem Implant Co., Ltd.
K161689, OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd.
. K172100, URIS OMNI System, TruAbutment Korea Co., Ltd.
K210354, SNUCONE Bone Level Implant System, SNUCONE Co., Ltd.
K052823, Implantium Abutment, Dentium Inc.
K140934, HIOSSEN Implant System, HiOSSEN Inc.
K161604, OSSTEM Implant System, Osstem Implant Co., Ltd.

IV. DEVICE DESCRIPTION

STERI-OSS Implant System. Abutment is inserted to support prosthesis such as artificial teeth, and is a medical device made of titanium alloy. It connects artificial teeth with a fixture implanted in the maxillary or mandibular alveolar bone where teeth are lost.

V. INDICATION FOR USE

STERI-OSS Implant System is intended for use in partially or fully edentulous mandibles and maxilla. in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. STERI-OSS Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.

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

VI. COMPARISON OF TECHNILOGICAL CHARACTERISTICS WITH THE REDICATE DEVICE

Item	Subject Device	Primary PredicateDevice	Reference Device	Reference Device
510(k) Number	K232268	K121995	K120503	K202039
Device Name	STERI-OSSImplant System	TS Fixture System	CMI Implant IS IIActive	Honorst ImplantSystem
Manufacturer	Zeros Co., Ltd.	Osstem Implant Co.,Ltd.	Neobiotech Co.,Ltd.	MEDIMECCA Co.,Ltd.
Indications forUse Statement	STERI-OSS ImplantSystem is intendedfor use in partiallyor fully edentulousmandibles andmaxilla, in supportof single ofmultiple-unitrestorationsincluding; cementedretained, screwretained, oroverdenturerestorations, andterminal orintermediateabutment support forfixed bridgework.STERI-OSS ImplantSystem is for singlestage and two stagesurgical procedures.This system isintended for delayedloading	The TS FixtureSystem is designedfor dental implantsurgery; it is placedin the maxillary ormandibular alveolarbone through asurgical procedure,and afterosseointegrationwith the alveolarbone, it can replace alost tooth byconnecting theabutment post.The TS FixtureSystem & TSIII SAUltra-Wide Fixtureare indicated for usein partially or fullyedentulousmandibles andmaxillae, in supportof single or multiple-unit restorationsincluding; cementedretained, oroverdenturerestorations, andfinal or temporaryabutment support forfixed bridgework. Itis intended fordelayed loading.	The CMI Implant ISII active is intendedto be surgicallyplaced in the bone ofthe upper or lowerjaw arches to providesupport forprosthetics devices.such as artificialteeth, and to restorethe patient's chewingfunction. It isintended forimmediate loadingwhen good primarystability is achievedand with appropriateocclusal loading.	Honorst ImplantSystem is intendedfor use in partially orfully edentulousmandibles andmaxilla, in support ofsingle of multipleunit restorationsincluding; cementedretained, screwretained, oroverdenturerestorations, andterminal orintermediateabutment support forfixed bridgework.Honorst ImplantSystem is for singlestage and two stagesurgical procedures.This system isintended for delayedloading
SubstantialEquivalenceDiscussion	Similarity :The subject device, "STERI-OSS Implant System", and primary predicate device,'TS Fixture System' (K121995) and reference devices 'CMI Implant IS II Active'(K120503)', 'Hornorst Implant System' (K202039) are dental implants that canrecover masticatory function when teeth are lost.

Table 1 : Substantial Equivalence – Indication for Use Statements

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

Difference :Indication for use of subject device is slight differences in phrase with theprimary predicate device (K121995), reference device (K120503), butfundamental indication is same.
Therefore, Indication for Use statement of the subject device, "STERI-OSSImplant System" is identical and substantially equivalent to the identified primarypredicate device, K121995 and reference devices, K202039.

Table 2 : Substantial Equivalence - EQUIVALENCE DISCUSSION

1. Fixture

Item	Subject Device	PrimaryPredicate Device	Reference Device	Reference Device
510(k)Number	K2322685	K121995	K120503	K202039
Device Name	STERI-OSSImplant System	TS FixtureSystem	CMI Implant IS IIActive	Honorst ImplantSystem
Manufacturer	Zeros Co., Ltd.	Osstem ImplantCo., Ltd.	Neobiotech Co.,Ltd.	MEDIMECCACo., Ltd.
Design	Image: Design of STERI-OSS Implant System	Image: Design of TS Fixture System	Image: Design of CMI Implant IS II Active	Image: Design of Honorst Implant System
Connectiontype	Internal Hex	Internal Hex	Internal Hex	Internal Hex
Material	Pure TitaniumGrade 4(ASTM F67)	Pure TitaniumGrade 4(ASTM F67)	Pure TitaniumGrade 4(ASTM F67)	Pure TitaniumGrade 4(ASTM F67)
Diameter&Length	TSII SA FixtureDiameter (mm) Length(mm) 3.8 8.5, 9, 10, 11, 11.5, 12, 13, 15 4.2 7, 8, 8.5, 9, 10, 11, 11.5, 12, 13, 15 4.6 7, 8, 8.5, 9, 10, 11, 11.5, 12, 13, 15 5.1 7, 8, 8.5, 9, 10, 11, 11.5, 12, 13 5.5 7, 8, 8.5, 9, 10, 11, 11.5, 12, 13 6.0 7, 8, 8.5, 9, 10, 11, 11.5, 12				TSII SA FixtureDiameter (mm) Length(mm) 3.5 8.5, 10, 11.5, 13, 15 4.2 7, 8.5, 10, 11.5, 13, 15 4.4 7, 8.5, 10, 11.5, 13, 15 4.9 7, 8.5, 10, 11.5, 13, 15 TSIII SA FixtureDiameter (mm) Length(mm) 3.75 10, 11.5, 13, 15 3.77 8.5 4.2 10, 11.5, 13, 15 4.25 7, 8.5 4.6 10, 11.5, 13, 15 4.63 8.5	Diameter (mm) Length(mm) 4.5 7.3, 8.5, 10.0, 11.5, 13.0, 15.0 5 7.3, 8.5, 10.0, 11.5, 13.0, 15.0 5.5 7.3, 8.5, 10.0, 11.5, 13.0, 15.0 6 7.3, 8.5, 10.0, 11.5, 13.0 7 7.3, 8.5, 10.0, 11.5, 13.0	Diameter (mm) Length(mm) 3.75 8.5, 10.0, 11.5, 13.0 4.2 7.0, 8.5, 10.0, 11.5, 13.0 4.6 7.0, 8.5, 10.0, 11.5, 13.0 5.1 7.0, 8.5, 10.0, 11.5, 13.0 5.5 7.0, 8.5, 10.0, 11.5, 13.0 6 7.0, 8.5, 10.0, 11.5, 12.5

ZEROS Co., Ltd.

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

5.05 10, 11.5, 13, 15 5.08 8.5 5.1 7 TSIII SA Ultra-Wide Fixture Diameter (mm) Length(mm) 5.92 11.2 5.95 9.7 6 7.2, 8.2 6.8 7.2, 8.2, 9.7, 11.2
Surface Treatment	SLA	SLA	SLA	SLA
Sterilization	Gamma Sterilization	Gamma Sterilization	Gamma Sterilization	Gamma Sterilization
Shelf life	5 years	8 years	5 years	5 years
Substantial Equivalence Discussion	Similarity :The subject device, "STERI-OSS Implant System" has almost the sameindications for use, raw material, and design when compared to the primarypredicate device, 'TS Fixture System'(K121995). The fixture surface treatmentmethod is the same as SLA, and the product is sterilized by gamma irradiation.In addition, the subject device is the same as the reference devices 'CMI ImplantIS II Active'(K120503) and 'Hornorst Implant System'(K202039) in the rawmaterial, design, surface treatment method (SLA), and sterilization method(gamma irradiation).Difference :In addition, although there is a slight difference between the dimensions of thesubject device and that of the predicate device (K121995) and reference devices(K120503, K202039), it is judged that they exist within a similar dimensionalrange overall.Therefore, "STERI-OSS Implant System" is similar in that they are threaded,root form implants with SLA surface treated. The subject and predicate fixturesare a similar body shape design such as cylindrical body design, similardimension range. The difference is very minor not affecting substantialequivalence.

2. Abutment

Item	Subject Device	Reference Device	Reference Device
510(k)Number	K232268	K182091	K172100
Device Name	STERI-OSS ImplantSystem	Osstem AbutmentSystem	URIS OMNI System
Manufacturer	Zeros Co., Ltd.	Osstem Implant Co., Ltd.	TruAbutment Korea Co.,Ltd.

ZEROS Co., Ltd.

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

Indication foruse	STERI-OSS ImplantSystem is intended foruse in partially or fullyedentulous mandiblesand maxilla, in supportof single of multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework.STERI-OSS ImplantSystem is for single stageand two stage surgicalprocedures. This systemis intended for delayedloading.	Osstem AbutmentSystem is intended foruse with a dental implantto provide support forprosthetic restorationssuch as crowns, bridges,or overdentures.	URIS OMNI System isindicated for use inpartially or fullyedentulous mandiblesand maxillae, in supportof single or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It isintended for delayedloading.
Part Name	Straight Abutment	Transfer Abutment	D Basis Abutment-Cemented Type
Design	Image: Straight Abutment	Image: Transfer Abutment	Image: D Basis Abutment
Principle ofoperation	Cement retainedrestoration	Cement retainedrestoration	Cement retainedrestoration
Material	Ti6Al4V ELI(ASTM F136)	Ti6Al4V ELI(ASTM F136)	Ti6Al4V ELI(ASTM F136)
Diameter(mm)	4.0, 4.5, 5.0, 5.5, 6.0, 6.5	4.0, 4.6, 5.0, 6.0, 7.0	4.0, 4.5, 5.5, 6.5
PostHeight(mm)	4.0, 5.5, 7.0	4.0, 5.5. 7.0	4.0, 5.5, 7.0
GingivalHeight(mm)	1.0, 2.0, 3.0, 4.0, 5.0, 6.0	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
SurfaceTreatment	None	TiN Coated (partially)	None
SubstantialEquivalenceDiscussion	Similarity :- Subject device, "Straight Abutment" is generally used for cement-retainedrestoration, and has the same function, indications for use, material compared tothat of the reference device, 'Transfer Abutment' in Osstem Abutment System(K182091). Also, subject device has the similar design (dimension range) andappearance compared to that of the reference device (K182091).- Indication for use of subject device is slight differences in phrase with thereference device (K182091), but fundamental indication is same.- Subject device has the same function, indications for use, material, surfacetreatment compared to that of the reference device (K172100).Difference :The subject device, "Straight Abutment", has a machined surface without surfacetreatment and is similar to the reference device (K172100). The reference device (K172100) has a TiN coated surface.

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

(K182091) was partially coated with TiN.

Therefore, the subject device, "Straight Abutment" is very similar to the reference device (K182091) in terms of function, purpose of use, raw materials (Ti alloys), design, etc., except for the different surface treatment. The difference is minor not affecting substantial equivalence.

Item	Subject Device	Reference Device	Reference Device
510(k)Number	K232268	K161689	K172100
Device Name	STERI-OSS ImplantSystem	OSSTEM ImplantSystem - Abutment	URIS OMNI System
Manufacturer	Zeros Co., Ltd.	Osstem Implant Co., Ltd.	TruAbutment Korea Co.,Ltd.
Indication foruse	STERI-OSS ImplantSystem is intended foruse in partially or fullyedentulous mandiblesand maxilla, in supportof single of multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework.STERI-OSS ImplantSystem is for single stageand two stage surgicalprocedures. This systemis intended for delayedloading.	The OSSTEM ImplantSystem - Abutment isintended for use with adental implant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures.	URIS OMNI System isindicated for use inpartially or fullyedentulous mandiblesand maxillae, in supportof single or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It isintended for delayedloading.
Part Name	Solid Abutment	Rigid Abutment	D Basis Abutment- Direct Type
Design	Image: Solid Abutment	Image: Rigid Abutment	Image: D Basis Abutment
Principle ofoperation	Cement retainedrestoration	Cement retainedrestoration	Cement retainedrestoration
Material	Ti6Al4V ELI(ASTM F136)	Ti6Al4V ELI(ASTM F136)	Ti6Al4V ELI(ASTM F136)
Diameter(mm)	4.0, 4.5, 5.0, 5.5, 6.0, 6.5	4.0, 4.6, 5.0, 6.0, 7.0	4.0, 4.5, 5.5, 6.5
PostHeight(mm)	4.0, 5.5, 7.0	4.0, 5.5, 7.0	4.0, 5.5, 7.0

ZEROS Co., Ltd.

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

GingivalHeight(mm)	1.0, 2.0, 3.0, 4.0, 5.0, 6.0	1.0, 2.0, 3.0, 4.0, 5.0	1.0, 2.0, 3.0, 4.0, 5.0, 6.0
SurfaceTreatment	None	TiN Coated (partially)	None
SubstantialEquivalenceDiscussion	Similarity : - Subject device, “Solid Abutment” is generally used for cement-retained restoration, and has the same function, indications for use, material compared to that of the reference device, 'Rigid Abutment' in Osstem Abutment System (K161689). Also, subject device has the similar design (dimension range) and appearance compared to that of the reference device (K161689). - Indication for use of subject device is slight differences in phrase with reference device (K161689), but fundamental indication is same. - Subject device has the same function, indications for use, material, surface treatment compared to that of the reference device (K172100).Difference : The subject device, “Solid Abutment”, has a machined surface without surface treatment and is similar to the reference device (K172100). The reference device (K161689) was partially coated with TiN.Therefore, the subject device and reference devices (K161689, K172100) have the similar intended use, design including diameter and lengths, and are made of same materials (Ti alloys) except for the different surface treatment. The difference is minor not affecting substantial equivalence.

Item	Subject Device	Reference Device	Reference Device
510(k)Number	K232268	K182091	K210354
Device Name	STERI-OSS ImplantSystem	OSSTEM ImplantSystem - Abutment	SNUCONE Bone LevelImplant System
Manufacturer	Zeros Co., Ltd.	Osstem Implant Co., Ltd.	SNUCONE Co., LTD.
Indication foruse	STERI-OSS ImplantSystem is intended foruse in partially or fullyedentulous mandiblesand maxilla, in supportof single of multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework.STERI-OSS ImplantSystem is for single stageand two stage surgicalprocedures. This system	The OSSTEM ImplantSystem - Abutment isintended for use with adental implant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures.	SNUCONE Bone LevelImplant System isindicated for use inpartially or fullyedentulous mandiblesand maxillae, in supportof single or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations and terminalor intermediateAbutment support forfixed bridge work.SNUCONE Bone LevelImplant System isdedicated for two stage

Page 7 / 16

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

	is intended for delayed		surgical procedures and
	loading.		for immediate loadingwhen there is goodprimary stability and anappropriate occlusalload. Also, implants withdiameters larger than5mm are indicated formolar regions.
Part Name	Angled Abutment	Angled Abutment	Abiding Couple AngledAbutment
Design	Image: Angled Abutment	Image: Angled Abutment	Image: Abiding Couple Angled Abutment
Principle ofoperation	Cement retainedrestoration	Cement retainedrestoration	Cement or screw retainedrestoration
Material	Ti6Al4V ELI(ASTM F136)	Ti6Al4V ELI(ASTM F136)	Ti6Al4V ELI(ASTM F136)
Diameter(mm)	4.0, 4.5, 5.0, 5.5, 6.0, 6.5	4.0, 4.5, 5.0, 6.0	4.0, 4.5, 5.0, 5.5, 6.5
PostHeight(mm)	8.0	8.0	7.0
GingivalHeight(mm)	1.0, 2.0, 3.0, 4.0, 5.0, 6.0	2.0, 4.0	2.0, 4.0, 6.0
Angle	15°, 25°	17°	15°, 25°
SurfaceTreatment	None	TiN Coated (partially)	None / Anodized
SubstantialEquivalenceDiscussion	Similarity :- Subject device, "Angled Abutment" is generally used for cement-retainedrestoration, and has the same function, indications for use, material compared tothat of the reference device, 'Angled Abutment' in Osstem Abutment System(K182091). Also, subject device has the similar design and appearance comparedto that of the reference device (K182091).- Subject device, "Angled Abutment" has the same function, indications for use,material, and the similar design (dimension range) and appearance compared tothat of the reference device (K210354).- Indication for use of subject device is slight differences in phrase with referencedevices, but fundamental indication is same.
	Difference :- In terms of surface treatment, the subject device, "Angled Abutment" has amachined surface without surface treatment and is similar to the product withoutsurface treatment among the reference devices (K210354). The reference device(K182091) was partially coated with TiN.
	- Dimension difference : Compared to the reference device (K182091), modelswith diameters of 5.5, 6.5 mm, and gingival heights of 1.0, 3.0, 5.0, and 6.0 mmare added to the subjective device. Also, there are differences in angles of 15°,25° in subjective device and 17° in reference device (K182091).

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

differences were addressed by the provided mechanical bench testing.

Therefore, the subject device, "Angled Abutment" is similar to the reference (K182091) in terms of function, purpose of use, raw materials (Ti alloys), design (dimension range and appearance) etc., except for the different surface treatment. The difference is minor not affecting substantial equivalence.

Item	Subject Device	Reference Device	Reference Device
510(k)Number	K232268	K161689	K052823
Device Name	STERI-OSS ImplantSystem	OSSTEM ImplantSystem - Abutment	Implantium Abutment
Manufacturer	Zeros Co., Ltd.	Osstem Implant Co., Ltd.	Dentium Inc.
Indication foruse	STERI-OSS ImplantSystem is intended foruse in partially or fullyedentulous mandiblesand maxilla, in supportof single of multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework.STERI-OSS ImplantSystem is for single stageand two stage surgicalprocedures. This systemis intended for delayedloading.	The OSSTEM ImplantSystem - Abutment isintended for use with adental implant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures.	The Implantiumabutments are intendedto be used with theImplantium root-formendosseous dentalimplant to aid inprosthetic rehabilitationincluding overdentureretention. After the root-form endosseous dentalimplant is surgicallyplaced, the endosseousdental implant abutmentdevice is attached to it.
Part Name	Temporary Abutment	Temporary Abutment	Temporary Abutment
Design	Image: Two temporary abutments	Image: Temporary abutment	Image: Temporary abutment
Principle ofoperation	temporary prostheses /Cement/screw retainedrestoration	temporary prostheses /Cement/screw retainedrestoration	temporary prostheses /Cement/screw retainedrestoration
Material	Ti6Al4V ELI(ASTM F136)	Titanium Gr.3(ASTM F67)	Ti6Al4V ELI(ASTM F136)
Diameter(mm)	4.5	4.0, 4.5	4.5
PostHeight(mm)	10.0	10.0	10.0
	4 mm for single-unitrestorations)
GingivalHeight(mm)	1.0	1.0, 3.0	1.0
SurfaceTreatment	None	None	None
Maximumduration	Less than 180 days	Less than 180 days	Less than 180 days
SubstantialEquivalenceDiscussion	Similarity :- Subject device, "Temporary Abutment" is generally used for cement/screw-retained restoration, and temporary prosthesis to maintain aesthetic appearanceuntil final prosthesis is made.- Subject device has the same function and the similar indications for use,dimension range compared to that of the reference device (K161689).- Subject device has the same function, indications for use, material, and thesimilar design compared to that of the reference device (K052823).- Indication for use of subject device is slight differences in phrase with thereference devices, but fundamental indication is same.Difference :- In terms of appearance (shape of the post), subjective device is different withthat of the reference device (K161689).- In the case of raw materials, Ti alloy is used for the subjective device, and cp-Tiis used for the reference device (K161689).Therefore, the subject device, "Temporary Abutment" is similar to the referencedevice (K161689) in terms of function, purpose of use, dimension range, exceptfor the different appearance and raw-materials. The difference is minor notaffecting substantial equivalence.

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

3. Screw

Item	Subject Device	Reference Device	Reference Device
510(k)Number	K232268	K161689	K052823
Device Name	STERI-OSS ImplantSystem	Osstem AbutmentSystem	Implantium abutments
Manufacturer	Zeros Co., Ltd.	Osstem Implant Co., Ltd.	Dentium Inc.
Indication foruse	STERI-OSS ImplantSystem is intended foruse in partially or fullyedentulous mandiblesand maxilla, in support ofsingle of multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutment	The OSSTEM ImplantSystem - Abutment isintended for use with adental implant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures.	The Implantiumabutments are intended tobe used with theImplantium root-formendosseous dentalimplant to aid inprosthetic rehabilitationincluding overdentureretention. After the root-form endosseous dentalimplant is surgically

{14}------------------------------------------------

	support for fixedbridgework.STERI-OSS ImplantSystem is for single stageand two stage surgicalprocedures. This systemis intended for delayedloading.		placed, the endosseousdental implant abutmentdevice is attached to it.
Part Name	Abutment Screw	Abutment Screw	Abutment Screw
Design	Image: Abutment Screw	Image: Abutment Screw	Image: Abutment Screw
Principle ofoperation	To connect the abutmentto the fixture	To connect the abutmentto the fixture	To connect the abutmentto the fixture
Material	Ti6Al4V ELI(ASTM F136)	Ti6Al4V ELI(ASTM F136)	Ti6Al4V ELI(ASTM F136)
Diameter(mm)	2.3	2.0, 2.05, 2.2, 2.3, 2.5	2.3
Length (mm)	9.3	3.35, 5.6, 7.5, 8.35, 9.6,10.2	7.3, 10.2
SurfaceTreatment	None	None	None
SubstantialEquivalenceDiscussion	Similarity :- Subject device, "Abutment Screw" is common in design to connect theabutment to the fixture, and has the same function, indications for use, material,design & appearance, surface treatment compared to that of the reference device(K161689) and reference device (K052823).- Indication for use of subject device is slight differences in phrase with thereference devices, but fundamental indication is same.Difference :- Dimension difference : There is a difference in diameter and length compared tothe reference device (K161689). However, the subjective device's dimension iswithin the reference device dimensions.Therefore, the subject device, "Abutment Screw" is similar to the referencedevice (K161689) in terms of function, purpose of use, raw materials (Ti alloys),design (dimension range and appearance), and surface treatment. The differenceof dimension is minor not affecting substantial equivalence.

Item	Subject Device	Reference Device	Reference Device
510(k)Number	K232268	K140934	K052823
Device Name	STERI-OSS ImplantSystem	HIOSSEN ImplantSystem	Implantium abutments

{15}------------------------------------------------

Manufacturer	Zeros Co., Ltd.	HIOSSEN Inc.	Dentium Inc.
Indication foruse	STERI-OSS ImplantSystem is intended foruse in partially or fullyedentulous mandiblesand maxilla, in support ofsingle of multiple-unitrestorations including:cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework.STERI-OSS ImplantSystem is for single stageand two stage surgicalprocedures. This systemis intended for delayedloading.	The HIOSSEN ImplantSystem is indicated foruse in partially or fullyedentulous mandiblesand maxillae, in supportof single or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It isintended for delayedloading. ETIII SA UltraWide Fixture is intendedto be used in the loarregion.	The Implantiumabutments are intended tobe used with theImplantium root-formendosseous dentalimplant to aid inprosthetic rehabilitationincluding overdentureretention. After the root-form endosseous dentalimplant is surgicallyplaced, the endosseousdental implant abutmentdevice is attached to it.
Part Name	Cover Screw	Cover Screw	Cover Screw
Design	Image: Cover Screw	Image: Cover Screw	Image: Cover Screw
Principle ofoperation	To protect the internalportion of the implant	To protect the internalportion of the implant	To protect the internalportion of the implant
Material	Ti6Al4V ELI(ASTM F136)	Titanium Gr 4(ASTM F67)	Ti6Al4V ELI(ASTM F136)
Diameter(mm)	3.5	3.03, 3.58, 3.25, 3.4,3.75, 3.9	3.4, 3.6, 3.8
Length (mm)	5.5	5.25, 5.9, 6.25, 6.85, 6.9,7.5	4.70~8.92
SurfaceTreatment	None	Anodized	None / Anodized
SubstantialEquivalenceDiscussion	Similarity :- Subject device, "Cover Screw" is a common design, and has the same function,indications for use, design & appearance, compared to that of the reference device(K140934) and reference device (K052823).- Indication for use of subject device is slight differences in phrase with thereference devices, but fundamental indication is same.Difference :- The difference in raw materials is Ti alloy for subjective devices and cp-Ti forreference devices (K140934). But, for reference devices (K052823), raw materialinformation is the same.- In subject device, one size is proposed, and cover screws of various sizes areproposed for reference devices (K140934). It exists in a range of dimensionscompared to reference devices (K140934).- In terms of surface treatment, the subject device, "Cover Screw" and referencedevice (K052823) have none-surface treatment. In reference device (K140934).

{16}------------------------------------------------

surface treatment as anodized is applied to the product.

Therefore, the subject device, "Cover Screw" is similar to the reference device (K140934) in terms of function, purpose of use, design (dimension range and appearance), except for the different surface treatment. The difference is minor not affecting substantial equivalence.

Item	Subject Device	Reference Device	Reference Device
510(k)Number	K232268	K161604	K052823
Device Name	STERI-OSS ImplantSystem	Osstem Implant System	Implantium abutments
Manufacturer	Zeros Co., Ltd.	Osstem Implant Co., Ltd.	Dentium Inc.
Indication foruse	STERI-OSS ImplantSystem is intended foruse in partially or fullyedentulous mandiblesand maxilla, in support ofsingle of multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework.STERI-OSS ImplantSystem is for single stageand two stage surgicalprocedures. This systemis intended for delayedloading	The OSSTEM ImplantSystem is indicated foruse in partially or fullyedentulous mandiblesand maxillae, in supportof single or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It isintended for delayedloading.	The Implantiumabutments are intended tobe used with theImplantium root-formendosseous dentalimplant to aid inprosthetic rehabilitationincluding overdentureretention. After the root-form endosseous dentalimplant is surgicallyplaced, the endosseousdental implant abutmentdevice is attached to it.
Part Name	Healing Abutment	Healing Abutment	Healing Abutment
Design	Image: Silver healing abutment	Image: Yellow and silver healing abutments	Image: Silver healing abutment
Principle ofoperation	To help the soft tissue ofgum naturally formed.	To help the soft tissue ofgum naturally formed.	To help the soft tissue ofgum naturally formed.
Material	Ti6Al4V ELI(ASTM F136)	Titanium Gr 4(ASTM F67)	Ti6Al4V ELI(ASTM F136)

{17}------------------------------------------------

Diameter(mm)	4.0, 4.5, 5.0, 5.5, 6.0, 6.5	4.3, 4.8, 5.3, 6.3, 7.3, 8.3	4.04~9.64
Length (mm)	9.0, 10.0, 11.0, 12.0,13.0, 14.0, 15.0	7.5, 8.5, 9.5, 10.5, 11.5,12.5, 13.5, 14.5	8.70~14.66
SurfaceTreatment	None	Anodized	None
SubstantialEquivalenceDiscussion	Similarity :- Subject device, "Healing Abutment" is a common design, and has the samefunction, indications for use, design & appearance compared to that of thereference device (K161604) and reference device (K052823).- Indication for use of subject device is slight differences in phrase with thereference devices, but fundamental indication is same.Difference :- The difference in raw materials is Ti alloy for subjective devices and cp-Ti forreference devices (K161604). But, for reference devices, raw materialinformation is the same.- In subjective device and reference device (K052823), surface treatment was notapplied. But surface treatment with anodizing was applied to reference device(K161604) partially.- In dimension, there is a slight difference between subjective and referencedevice (K161604).Therefore, the subject device, "Healing Abutment" is similar to the referencedevice (K161604) in terms of function, purpose of use, design (dimension rangeand appearance) etc.

VII. SUBSTANTIAL EQUIVALENCE DISCUSSION

The subject device has same device characteristics and indications for use with the primary predicate and reference device as dental implant system. It is intended purpose as they are placed in the alveolar bone to replace the function of missing tooth.

The various dimensions of subject devices are slightly different from the predicate devices. However, the dimensions of the subject device are in the range of the dimensions of the predicate and reference devices.

Differences in dimensions are supported by the mechanical bench testing. The bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics doesn't impact substantial equivalence.

Therefore, it is concluded that STERI-OSS Implant System is substantially equivalent to the predicate devices.

VIII. NON CLINICAL TESTING

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

Surface modification testing, utilizing EDS and SEM evaluations was conducted to demonstrate consistency and appropriateness of the S.L.A. treated implant surface.
. Fatigue Testing according to ISO 14801:2016 under the worst-case scenario

{18}------------------------------------------------

Gamma sterilization validation Test Report according to ISO 11137-1 and ISO 11137-2
. End User Sterilization Validation Test Report according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, ISO 11138-1 and ISO 11138-3
. Shelf life Test according to ASTM F88, ASTM F1140, ASTM F1929, and ASTM F2096
. Biocompatibility evaluations according to ISO 10993-1 and Biocompatibility testing according to ISO 10993-5 and ISO 10993-12

Pyrogen and Endotoxin Test

The subject device will not be labeled as "non-pyrogenic", and the endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL in accordance with the USP <85> "Bacterial Endotoxins Test".

MR Compatibility

Non-clinical worst-case MRI review was performed to evaluate the STERI-OSS Implant System in the MRI environment using scientific rationale and published literature (e.g., Terry O. Woods, 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. No.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, 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.

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

{19}------------------------------------------------

IX. Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act.21 CFR Part 807 and based on the information provided in this premarket notification Zeros Co., Ltd. concludes that the STERI-OSS Implant System is substantially equivalent to the predicate device as described herein.

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.