Predicate Devices

Reference Devices

K120503, K202039, K182091, K161689, K172100, K210354, K052823, K140934, K161604

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard dental implant system made of titanium, focusing on its mechanical properties, sterilization, and biocompatibility. There is no mention of any software, algorithms, image processing, or data analysis that would suggest the use of AI/ML.

Therapeutic

Yes

The device, the STERI-OSS Implant System, is intended for use in partially or fully edentulous mandibles and maxilla to support various restorations (e.g., artificial teeth) for the recovery of masticatory function, thereby providing a therapeutic benefit to the patient.

Diagnostic

No

Explanation: The device is an implant system (STERI-OSS Implant System) intended to support artificial teeth for the recovery of masticatory function. Its purpose is to restore function, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states the device is made of titanium and titanium alloy, indicating it is a physical hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes the device as being used in the body (implanted in bone) to support dental prostheses. IVDs are used outside the body to examine specimens (like blood, urine, or tissue) to provide information about a person's health.
Device Description: The description clearly states the device is a medical device made of titanium that is inserted into the bone. This is a physical implant, not a diagnostic test.
Lack of Diagnostic Function: There is no mention of the device being used to diagnose, monitor, or screen for any condition. Its purpose is purely structural support for dental restorations.
Performance Studies: The performance studies focus on physical properties, sterilization, biocompatibility, and shelf life, which are typical for implantable medical devices, not IVDs.

Therefore, the STERI-OSS Implant System is a medical device, specifically a dental implant system, and not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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 surgical procedures. This system is intended for delayed loading.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

partially or fully edentulous mandibles and maxilla

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
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

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.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K121995

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K120503, K202039, K182091, K161689, K172100, K210354, K052823, K140934, K161604

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

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

Summary

0

Image /page/0/Picture/0 description: The image 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)

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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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, 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.

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 Predicate
Device | Reference Device | Reference Device |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K232268 | K121995 | K120503 | K202039 |
| Device Name | STERI-OSS
Implant System | TS Fixture System | CMI Implant IS II
Active | Honorst Implant
System |
| Manufacturer | Zeros Co., Ltd. | Osstem Implant Co.,
Ltd. | Neobiotech Co.,
Ltd. | MEDIMECCA Co.,
Ltd. |
| Indications for
Use Statement | 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, screw
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 | The TS Fixture
System is designed
for dental implant
surgery; it is placed
in the maxillary or
mandibular alveolar
bone through a
surgical procedure,
and after
osseointegration
with the alveolar
bone, it can replace a
lost tooth by
connecting the
abutment post.
The TS Fixture
System & TSIII SA
Ultra-Wide Fixture
are indicated for use
in partially or fully
edentulous
mandibles and
maxillae, in support
of single or multiple-
unit restorations
including; cemented
retained, or
overdenture
restorations, and
final or temporary
abutment support for
fixed bridgework. It
is intended for
delayed loading. | The CMI Implant IS
II active is intended
to be surgically
placed in the bone of
the upper or lower
jaw arches to provide
support for
prosthetics devices.
such as artificial
teeth, and to restore
the patient's chewing
function. It is
intended for
immediate loading
when good primary
stability is achieved
and with appropriate
occlusal loading. | Honorst 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, screw
retained, or
overdenture
restorations, and
terminal or
intermediate
abutment support for
fixed bridgework.
Honorst Implant
System is for single
stage and two stage
surgical procedures.
This system is
intended for delayed
loading |
| Substantial
Equivalence
Discussion | 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 can
recover masticatory function when teeth are lost. | | | |

Table 1 : Substantial Equivalence – Indication for Use Statements

6

Г

| Difference :
Indication for use of subject device is slight differences in phrase with the
primary predicate device (K121995), reference device (K120503), but

fundamental indication is same.
Therefore, Indication for Use statement of the subject device, "STERI-OSS
Implant System" is identical and substantially equivalent to the identified primary
predicate device, K121995 and reference devices, K202039.

Table 2 : Substantial Equivalence - EQUIVALENCE DISCUSSION

1. Fixture

| Item | Subject Device | Primary
Predicate Device | Reference Device | Reference Device | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|-------------------------------------------|-----------------------------------------|--|--|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| 510(k)
Number | K2322685 | K121995 | K120503 | K202039 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | STERI-OSS
Implant System | TS Fixture
System | CMI Implant IS II
Active | Honorst Implant
System | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Manufacturer | Zeros Co., Ltd. | Osstem Implant
Co., Ltd. | Neobiotech Co.,
Ltd. | MEDIMECCA
Co., 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 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Connection
type | Internal Hex | Internal Hex | Internal Hex | Internal Hex | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Diameter
&
Length | TSII SA Fixture
Diameter (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 Fixture
Diameter (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 Fixture
Diameter (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.

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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 same
indications for use, raw material, and design when compared to the primary
predicate device, 'TS Fixture System'(K121995). The fixture surface treatment
method 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 Implant
IS II Active'(K120503) and 'Hornorst Implant System'(K202039) in the raw
material, design, surface treatment method (SLA), and sterilization method
(gamma irradiation).
Difference :
In addition, although there is a slight difference between the dimensions of the
subject device and that of the predicate device (K121995) and reference devices
(K120503, K202039), it is judged that they exist within a similar dimensional
range overall.
Therefore, "STERI-OSS Implant System" is similar in that they are threaded,
root form implants with SLA surface treated. The subject and predicate fixtures
are a similar body shape design such as cylindrical body design, similar
dimension range. The difference is very minor not affecting substantial
equivalence.

2. Abutment

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

ZEROS Co., Ltd.

8

| 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, screw
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. | Osstem Abutment
System is intended for
use with a dental implant
to provide support for
prosthetic restorations
such as crowns, bridges,
or overdentures. | URIS OMNI 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 final or
temporary abutment
support for fixed
bridgework. It is
intended for delayed
loading. |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Part Name | Straight Abutment | Transfer Abutment | D Basis Abutment-
Cemented Type |
| Design | Image: Straight Abutment | Image: Transfer Abutment | Image: D Basis Abutment |
| Principle of
operation | Cement retained
restoration | Cement retained
restoration | Cement retained
restoration |
| 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 |
| Post
Height(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5. 7.0 | 4.0, 5.5, 7.0 |
| Gingival
Height(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 |
| Surface
Treatment | None | TiN Coated (partially) | None |
| Substantial
Equivalence
Discussion | Similarity :

Subject device, "Straight Abutment" is generally used for cement-retained
restoration, and has the same function, indications for use, material compared to
that of the reference device, 'Transfer Abutment' in Osstem Abutment System
(K182091). Also, subject device has the similar design (dimension range) and
appearance compared to that of the reference device (K182091).
Indication for use of subject device is slight differences in phrase with the
reference device (K182091), 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, "Straight Abutment", has a machined surface without surface
treatment 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 Implant
System	OSSTEM Implant
System - Abutment	URIS OMNI System
Manufacturer	Zeros Co., Ltd.	Osstem Implant Co., Ltd.	TruAbutment Korea Co.,
Ltd.
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, screw
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.	The OSSTEM Implant
System - Abutment is
intended for use with a
dental implant to provide
support for prosthetic
restorations such as
crowns, bridges, or
overdentures.	URIS OMNI 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 final or
temporary abutment
support for fixed
bridgework. It is
intended for delayed
loading.
Part Name	Solid Abutment	Rigid Abutment	D Basis Abutment

Direct Type |
| Design | Image: Solid Abutment | Image: Rigid Abutment | Image: D Basis Abutment |
| Principle of
operation | Cement retained
restoration | Cement retained
restoration | Cement retained
restoration |
| 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 |
| Post
Height(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 |

ZEROS Co., Ltd.

10

| Gingival

Height(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
Surface
Treatment	None	TiN Coated (partially)	None
Substantial
Equivalence
Discussion	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 Implant
System	OSSTEM Implant
System - Abutment	SNUCONE Bone Level
Implant System
Manufacturer	Zeros Co., Ltd.	Osstem Implant Co., Ltd.	SNUCONE Co., LTD.
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, screw
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	The OSSTEM Implant
System - Abutment is
intended for use with a
dental implant to provide
support for prosthetic
restorations such as
crowns, bridges, or
overdentures.	SNUCONE Bone Level
Implant System is
indicated for use in
partially or fully
edentulous mandibles
and maxillae, in support
of single or multiple-unit
restorations including;
cemented retained, screw
retained, or overdenture
restorations and terminal
or intermediate
Abutment support for
fixed bridge work.
SNUCONE Bone Level
Implant System is
dedicated for two stage

Page 7 / 16

11

	is intended for delayed		surgical procedures and
	loading.		for immediate loading
when there is good
primary stability and an
appropriate occlusal
load. Also, implants with
diameters larger than
5mm are indicated for
molar regions.
Part Name	Angled Abutment	Angled Abutment	Abiding Couple Angled
Abutment
Design	Image: Angled Abutment	Image: Angled Abutment	Image: Abiding Couple Angled Abutment
Principle of
operation	Cement retained
restoration	Cement retained
restoration	Cement or screw retained
restoration
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
Post
Height(mm)	8.0	8.0	7.0
Gingival
Height(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°
Surface
Treatment	None	TiN Coated (partially)	None / Anodized
Substantial
Equivalence
Discussion	Similarity :

Subject device, "Angled Abutment" is generally used for cement-retained
restoration, and has the same function, indications for use, material compared to
that of the reference device, 'Angled Abutment' in Osstem Abutment System
(K182091). Also, subject device has the similar design and appearance compared
to 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 to
that of the reference device (K210354).
Indication for use of subject device is slight differences in phrase with reference
devices, but fundamental indication is same. | | |
| | Difference :
In terms of surface treatment, the subject device, "Angled Abutment" has a
machined surface without surface treatment and is similar to the product without
surface treatment among the reference devices (K210354). The reference device
(K182091) was partially coated with TiN. | | |
| | - Dimension difference : Compared to the reference device (K182091), models
with diameters of 5.5, 6.5 mm, and gingival heights of 1.0, 3.0, 5.0, and 6.0 mm
are 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 Implant
System	OSSTEM Implant
System - Abutment	Implantium Abutment
Manufacturer	Zeros Co., Ltd.	Osstem Implant Co., Ltd.	Dentium Inc.
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, screw
retained, or overdenture
restorations, and terminal
or intermediate abutment
support for fixed
bridgework.

Subject device, "Temporary Abutment" is generally used for cement/screw-
retained restoration, and temporary prosthesis to maintain aesthetic appearance
until 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 the
similar design compared to that of the reference device (K052823).
Indication for use of subject device is slight differences in phrase with the
reference devices, but fundamental indication is same.
Difference :
In terms of appearance (shape of the post), subjective device is different with
that of the reference device (K161689).
In the case of raw materials, Ti alloy is used for the subjective device, and cp-Ti
is used for the reference device (K161689).
Therefore, the subject device, "Temporary Abutment" is similar to the reference
device (K161689) in terms of function, purpose of use, dimension range, except
for the different appearance and raw-materials. The difference is minor not
affecting substantial equivalence. | | |

13

3. Screw

Item	Subject Device	Reference Device	Reference Device
510(k)
Number	K232268	K161689	K052823
Device Name	STERI-OSS Implant
System	Osstem Abutment
System	Implantium abutments
Manufacturer	Zeros Co., Ltd.	Osstem Implant Co., Ltd.	Dentium Inc.
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, screw
retained, or overdenture
restorations, and terminal
or intermediate abutment	The OSSTEM Implant
System - Abutment is
intended for use with a
dental implant to provide
support for prosthetic
restorations such as
crowns, bridges, or
overdentures.	The Implantium
abutments are intended to
be used with the
Implantium root-form
endosseous dental
implant to aid in
prosthetic rehabilitation
including overdenture
retention. After the root-
form endosseous dental
implant is surgically

14

| | support for fixed
bridgework.
STERI-OSS Implant
System is for single stage
and two stage surgical
procedures. This system
is intended for delayed
loading. | | placed, the endosseous
dental implant abutment
device is attached to it. |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--------------------------------------------------------------------------------|
| Part Name | Abutment Screw | Abutment Screw | Abutment Screw |
| Design | Image: Abutment Screw | Image: Abutment Screw | Image: Abutment Screw |
| Principle of
operation | To connect the abutment
to the fixture | To connect the abutment
to the fixture | To connect the abutment
to 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 |
| Surface
Treatment | None | None | None |
| Substantial
Equivalence
Discussion | Similarity :

Subject device, "Abutment Screw" is common in design to connect the
abutment 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 the
reference devices, but fundamental indication is same.
Difference :
Dimension difference : There is a difference in diameter and length compared to
the reference device (K161689). However, the subjective device's dimension is
within the reference device dimensions.
Therefore, the subject device, "Abutment Screw" is similar to the reference
device (K161689) in terms of function, purpose of use, raw materials (Ti alloys),
design (dimension range and appearance), and surface treatment. The difference
of dimension is minor not affecting substantial equivalence. | | |

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

15

Manufacturer	Zeros Co., Ltd.	HIOSSEN Inc.	Dentium Inc.
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, screw
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.	The HIOSSEN 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 final or
temporary abutment
support for fixed
bridgework. It is
intended for delayed
loading. ETIII SA Ultra
Wide Fixture is intended
to be used in the loar
region.	The Implantium
abutments are intended to
be used with the
Implantium root-form
endosseous dental
implant to aid in
prosthetic rehabilitation
including overdenture
retention. After the root-
form endosseous dental
implant is surgically
placed, the endosseous
dental implant abutment
device is attached to it.
Part Name	Cover Screw	Cover Screw	Cover Screw
Design	Image: Cover Screw	Image: Cover Screw	Image: Cover Screw
Principle of
operation	To protect the internal
portion of the implant	To protect the internal
portion of the implant	To protect the internal
portion 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
Surface
Treatment	None	Anodized	None / Anodized
Substantial
Equivalence
Discussion	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 the
reference devices, but fundamental indication is same.
Difference :
The difference in raw materials is Ti alloy for subjective devices and cp-Ti for
reference devices (K140934). But, for reference devices (K052823), raw material
information is the same.
In subject device, one size is proposed, and cover screws of various sizes are
proposed for reference devices (K140934). It exists in a range of dimensions
compared to reference devices (K140934).
In terms of surface treatment, the subject device, "Cover Screw" and reference
device (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 Implant
System	Osstem Implant System	Implantium abutments
Manufacturer	Zeros Co., Ltd.	Osstem Implant Co., Ltd.	Dentium Inc.
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, screw
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	The OSSTEM 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 final or
temporary abutment
support for fixed
bridgework. It is
intended for delayed
loading.	The Implantium
abutments are intended to
be used with the
Implantium root-form
endosseous dental
implant to aid in
prosthetic rehabilitation
including overdenture
retention. After the root-
form endosseous dental
implant is surgically
placed, the endosseous
dental implant abutment
device 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 of
operation	To help the soft tissue of
gum naturally formed.	To help the soft tissue of
gum naturally formed.	To help the soft tissue of
gum 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
Surface
Treatment	None	Anodized	None
Substantial
Equivalence
Discussion	Similarity :

Subject device, "Healing Abutment" is a common design, and has the same
function, indications for use, design & appearance compared to that of the
reference device (K161604) and reference device (K052823).
Indication for use of subject device is slight differences in phrase with the
reference devices, but fundamental indication is same.
Difference :
The difference in raw materials is Ti alloy for subjective devices and cp-Ti for
reference devices (K161604). But, for reference devices, raw material
information is the same.
In subjective device and reference device (K052823), surface treatment was not
applied. But surface treatment with anodizing was applied to reference device
(K161604) partially.
In dimension, there is a slight difference between subjective and reference
device (K161604).
Therefore, the subject device, "Healing Abutment" is similar to the reference
device (K161604) in terms of function, purpose of use, design (dimension range
and 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 "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.