Predicate Devices

K140806,K162099,K173120,K192197,K212517,K152520,K162099

Reference Devices

K152520, K173120, K181138, K182448, K192197, K200753

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental implant system and its components, focusing on materials, surface treatments, and mechanical/biocompatibility testing. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of such technologies.

Therapeutic

No
The device is described as an endosseous dental implant system intended to replace missing teeth and restore chewing function, which classifies it as a medical device for structural support and function, not a therapeutic device.

Diagnostic

No

The device is described as an endosseous dental implant system intended to replace missing teeth and restore chewing function. It consists of fixtures and abutments for surgical procedures, indicating a therapeutic or restorative purpose rather than a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (fixtures and abutments made of Ti-6AL-4V Eli) and the performance studies detail testing on these physical components (sterilization, biocompatibility, fatigue testing, packaging). This indicates it is a hardware medical 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 is to "replace missing teeth to restore chewing function." This is a therapeutic and restorative purpose, not a diagnostic one.
Device Description: The device consists of dental implants (fixtures) and abutments, which are physical components implanted into the body. IVD devices are typically used to examine specimens from the body (like blood, urine, tissue) to provide diagnostic information.
Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, measure a substance in a biological sample, or provide information about a patient's health status based on in vitro analysis.
Performance Studies: The performance studies focus on biocompatibility, sterilization, fatigue testing, and packaging, which are relevant to the safety and function of an implantable medical device, not an IVD.

In summary, the IBS System is a dental implant system designed for surgical implantation to replace missing teeth. This falls under the category of a medical device, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The IBS System is intended to replace missing teeth to restore chewing function. The IBS System can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

Product codes

DZE, NHA

Device Description

The IBS System includes fixtures (Magicore (RBM), Magicore (RBM Cutting Edge), Magicore II (SLA), Magicore II (SLA Cutting Edge)) and abutments (Magic Angled Abutment, Magic Motion, Magic Motion Housing, Magic Abutment, Magic Multiunit Abutment, Magic Multiunit Cap). Endosseous dental implants are made of Ti-6AL-4V Eli. The implant-abutment connection features internal hex, non-hex, and Morse taper bevel. Magicore implants use RBM (Resorbable Blasted media) surface treatment, while Magicore II implants use SLA (sand-blasted, large-grit, acid-etched) treatment. Fixtures are provided sterile. Abutments are provided non-sterile and require end-user sterilization. The Magic Motion Ball Pin is Ti-6Al-4V ELI, and the body is Co-Cr-Mo Alloy.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

Non-Clinical Data:
Below tests were performed on the subject device:

End User Sterilization Validation Test Report on Abutments made of Titanium ELI with RBM(Blasting) Surface treatment according to ANSVAAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1
Biocompatibility testing according to the ISO10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, and ISO 10993-10:2010 on abutments made of Titanium ELI with RBM(Blasting) Surface treatment.

Below tests were performed for predicate devices and leveraged for the subject device:

Biocompatibility testing according to ISO 10993-1:2009. ISO 10993-3:2014. ISO 10993-. 5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures referenced in K140806 & K162099
Biocompatibility testing according to ISO 10993-1:2009. ISO 10993-5:2009. ISO 10993-● 6:2007, and ISO 10993-10:2010 on abutments made of Titanium ELI referenced in K140806 & on Abutments made of CCM alloy referenced in K173120
LAL information/testing per USP as referenced in K162099
Sterilization validation for devices on Fixtures according to ISO 11137-1 and ISO 11137-2
Shelf Life Test Report on Fixture and Magicore Cap according to ASTM F1980
End User Sterilization Validation Test Report on Abutments made of Titanium ELI according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K192197
Fatigue Testing according to ISO 14801:2016 referenced in K212517

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

The surface modification information with RBM (Resorbable Blasted media) and SLA(sand-blasted, large-grit, acid-etched)was provided. To compare surface modification between the subject and predicate devices, K152520 and K162099, surface roughness, surface composition analysis, and SEM imaging were provided, and it demonstrate the substantial equivalence.

The end user sterilization validation testing was performed on abutment made of Titanium ELI with RBM(Blasting) Surface treatment under the worst-case construction. This sterilization cycle has been validated by the overkill method to a sterility assurance level (SAL) of 10-6 according to ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The biocompatibility testing was performed on abutments made of Titanium ELI with RBM(Blasting) Surface treatment according to the ISO10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and it demonstrate the subject abutments are biocompatible.

Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments".

Performance testing of Fixture Packaging -
Below performance testing and information have been provided for subject implant fixture packaging:

Human Factors testing (A usability evaluation for aseptic presentation of the subject device, in line with ISO 11607-1:2019 and the recommendations of the FDA guidance document, "Applying Human Factors and Usability Engineering to Medical Devices.")
Low and high magnification images at various degrees of rotation following the removal from the packaging (Evaluation of the broken tip at various degrees rotation at a high magnification and low magnification for damage after removal from the packaging and disconnection of the fixture jig)
Quality System (QS) plan including the method and frequency of acceptance activities to ensure that the devices conform with product specifications with packaging design.

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

Not Found

Predicate Device(s)

K212517

Reference Device(s)

K152520, K173120, K181138, K182448, K192197, K200753

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

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

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

12/20/22

Re: K220517

Trade/Device Name: IBS System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 21, 2022 Received: November 21, 2022

Dear April Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Sherrill Lathrop Blitzer

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

Enclosure

2

Indications for Use

510(k) Number (if known) K220517

Device Name IBS System

Indications for Use (Describe)

The IBS System is intended to replace missing teeth to restore chewing function. The IBS System can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two 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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3

510(K) Summary

Submitter

InnoBioSurg Co., Ltd. Ga Yun Kim 44-19. Techno 10-ro. Yuseong-gu Daejeon, 34027 Republic of Korea Email: gykim1@ibsimplant.com Tel. +82-42-933-2879 Fax. +82-42-933-2881

Device Information

Trade Name: IBS System .
. Common Name: Endosseous Dental Implant
Classification Name: Implant, Endosseous, Root-Form .
Product Code: DZE
. Secondary Product Code: NHA
. Panel: Dental
. Regulation Number: 872.3640
. Date prepared: 12/20/2022

Predicate Devices:

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

Primary Predicate K212517, Magicore System by InnoBioSurg Co., Ltd.

Reference Device

K152520, Magicore System by InnoBioSurg Co., Ltd. K173120, CCM Abutment System by InnoBioSurg Co., Ltd. K181138, CMI Implant IS System by Neobiotech Co. Ltd. K182448, AnyRidge Octa 1 Implant System by MegaGen Implant Co. Ltd. K192197, Magicore II System by InnoBioSurg Co., Ltd. K200753, IBS Implant System II by InnoBioSurg Co., Ltd.

Indication for Use:

The IBS System is intended to replace missing teeth to restore chewing function. The IBS System can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

Official Correspondent

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

4

Device Description

The fixtures and abutments in this system are below:

Fixture

Magicore (RBM)
Magicore (RBM Cutting Edge)
Magicore II (SLA) .
Magicore II (SLA Cutting Edge)
1. Abutment
- Magic Angled Abutment (Screw type _Hex, Non-Hex) ●
- Magic Motion
- Magic Motion Housing ●
- Magic Abutment (Screw type Hex, Non-Hex & Cement type Hex, Non-Hex) ●
- Magic Multiunit Abutment (Cement type Hex, Non-Hex)
- Magic Multiunit Cap .

An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The implant-abutment connection is tight and precise fitting with internal hex, non-hex and Morse taper bevel. The surface of the Magicore implant is treated with RBM (Resorbable Blasted media) and Magicore II implants are treated with SLA(sand-blasted, large-grit, acid-etched).

Below is the fixture dimension range:

| Fixture | Platform
Diameters (Ø) | Fixture
Diameters (Ø) | Cuff Lengths
(mm) | Implantable Lengths
(mm) |
|----------------------------------------------------------|---------------------------|--------------------------|-----------------------|------------------------------------------|
| Magicore (RBM) | 5.7 | 7.0 | 1.0, 2.0, 3.0,
4.0 | 11.0 ,12.0 ,13.0 |
| Magicore (RBM
_ Cutting Edge) | | 7.5 | | 10.0, 11.0, 12.0, 13.0 |
| | | 8.0 | | 9.0, 10.0, 11.0, 12.0, 13.0 |
| Magicore II (SLA)
Magicore II (SLA
_ Cutting Edge) | 5.7 | 7.0, 7.5, 8.0 | 1.0, 2.0, 3.0,
4.0 | 7.0, 8.0, 9.0, 10.0, 11.0,
12.0, 13.0 |

The subject fixtures are provided sterile.

Below is the abutment dimension range:

| Abutments | Uses | Diameter
(Ø) | Total Length
(mm) | Angle(°) | Surface |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------------------------------------------------------------------|----------|----------|
| Magic Angled
Abutment
(Screw type _Hex,
Non-Hex) | The Abutment is connected
with fixture and it supports
prosthesis which restores
tooth function. | 5.3 | 8.45, 8.96, 9.45,
9.96, 10.45, 10.96,
11.45, 11.96 | 15, 23 | machined |
| | | 6.3 | 8.68, 9.32, 9.68,
10.32, 10.68,
11.32, 11.68, 12.32 | | |
| Magic Motion | The Magic Motion
Abutment is connected
with fixture and replace
missing teeth to restore
chewing function. | 4.0 | 10.61, 11.11,
11.56, 12.06,
12.11, 13.06,
13.11, 14.06,
14.11, 15.06 | - | machined |
| Magic Motion
Housing | The Magic Motion
Housing is connected with
magic motion and replace
missing teeth to restore
chewing function. | 5.16 | 3.3 | - | machined |

5

| Magic Abutment
(Screw type _ Hex,
Non-Hex) | The Abutment is connected
with fixture and it supports
prosthesis which restores
tooth function. | 5.2, 5.7,
6.2, 6.7 | 4.51, 5.51, 6.51,
7.51,
8.51 | - | RBM
(Blasting) |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|------------------------------------|----------|-------------------|
| Magic Abutment
(Cement type _
Hex, Non-Hex) | The Abutment is connected
with fixture and it supports
prosthesis which restores
tooth function. | 5.2, 5.7,
6.2, 6.7 | 6.5, 7.5, 8.5, 9.5,
10.5 | - | RBM
(Blasting) |
| Magic Multiunit
Abutment
(Cement type _
Hex, Non-Hex) | The Abutment is connected
with fixture and it supports
prosthesis which restores
tooth function. | 4.8 | 5.7, 6.7, 7.7, 8.7 | 0, 5, 10 | RBM
(Blasting) |
| | | | 5.66, 6.66, 7.66,
8.66 | 15 | |
| | | | 6.0, 7.0, 8.0, 9.0 | 20 | |
| | | | 6.237, 7.237,
8.237, 9.237 | 25 | |
| | | 5.8 | 5.76, 6.76, 7.76,
8.76 | 0, 5, 10 | |
| | | | 5.69, 6.69, 7.69,
8.69 | 15 | |
| | | | 5.96, 6.96, 7.96,
8.96 | 20 | |
| | | | 6.344, 7.334,
8.334, 9.344 | 25 | |
| Magic Multiunit
Cap | Caps lead to accurate
closure of soft tissue
surrounding implant and
provide a definite shape
and form to gingiva which
is aesthetically close to
natural look. | 5.4, 6.4 | 4.3 | - | RBM
(Blasting) |

The abutments are provided non-sterile and packaged separately. The abutments should be sterilized before use by End User sterilization.

Materials:

The Magicore, Magicore II fixtures, Magic Angled Abutment, Magic Motion Housing, Magic . Abutment, Magic Multiunit Abutment and Magic Multiunit cap are made of Ti-6Al-4V ELI
. The Ball Pin of the Magic Motion is made of Ti-6Al-4V ELI and the body of the Magic Motion is made of Co-Cr-Mo Alloy.

6

Summaries of Technological Characteristics & Substantial Equivalence Discussion

1) Magicore and Magicore II Fixtures
	Subject Device	Primary predicate	Reference predicate
Manufacturer	InnoBioSurg Co., Ltd	InnoBioSurg Co., Ltd	InnoBioSurg Co., Ltd
Device Name	IBS System	Magicore System	Magicore II System
510(k) No.	K220517	K212517	K192197
Indications for use	The IBS Implant System is
intended to replace missing
teeth to restore chewing
function. The IBS Implant
System can be placed in
support of single or multiple-
unit restorations including;
cement retained, screw
retained, or overdenture
restorations, and terminal or
immediate abutment support
for fixed bridgework. This
system is for one or two stage
surgical procedures. This
system is intended for
delayed loading.	The Magicore System is
intended to replace missing
teeth to restore chewing
function. The Magicore
System can be placed in
support of single or multiple-
unit restorations including;
cement retained, screw
retained, or overdenture
restorations, and terminal or
immediate Abutment support
for fixed bridgework. This
system is for one or two stage
surgical procedures. This
system is intended for
delayed loading.	The Magicore II System is
intended to replace missing
teeth to restore chewing
function. The Magicore II
System can be placed in
support of single or
multipleunit restorations
including; cement retained
screw retained, or
overdenture restorations,
and terminal or immediate
abutment support for fixed
bridgework. This system is
for one or two stage
surgical procedures. This
system is intended for
delayed loading
Design	Image: Magicore	Image: Magicore II	Image: Magicore II
	Cutting Edge
Non-Cutting Edge	Cutting Edge
Non-Cutting Edge	Cutting Edge
Non-Cutting Edge
Material	Ti-6Al-4V Eli	Ti-6Al-4V Eli	Ti-6Al-4V Eli
Connection	Internal Hex
Non - Submerged	Internal Hex
Non - Submerged	Internal Hex
Non - Submerged
Endosseous Implant	Tapered, macro threads	Tapered, macro threads	Tapered, macro threads
Platform
Diameters (Ø)	5.7	5.2	4.7, 5.2, 5.7
Fixture
Diameters (Ø)	7.0, 7.5, 8.0	5.0, 5.5,
6.0, 6.5	4.0, 4.5, 5.0, 5.5, 6.0, 6.5
Cuff Lengths
(mm)	1.0, 2.0, 3.0, 4.0	1.0, 2.0, 3.0, 4.0	0, 1.0, 2.0, 3.0, 4.0, 5.0,
6.0, 7.0, 8.0, 9.0, 10.0
Implantable
Lengths (mm)	11.0, 12.0,
13.0
10.0, 11.0,
12.0, 13.0
9.0, 10.0,
11.0, 12.0,
13.0	7.0, 8.0, 9.0,
10.0, 11.0,
12.0, 13.0	7.0, 8.0, 9.0, 10.0, 11.0,
12.0, 13.0
Surface	R.B.M	S.L.A	S.L.A
Treatment		R.B.M
Surgical
Technique	1 and 2 stage, self-tapping	1 and 2 stage, self-tapping	1 stage and 2 stage, self
tapping
Gamma
Sterilization	Yes	Yes	Yes
SE Discussion	The subject IBS System has same indications for Use, material, surface treatment,
connection, general shape (Design), surface structure, applied production method and
surgical technique as the Primary Predicate, K212517. For SLA surface treatment and
Magicore II fixture's design of the subject device, K192197 was added as a reference
device. Therefore, subject device and predicate devices are substantially equivalent.

1) Magicore and Magicore II Fixtures

7

Abutment

	Subject Device	Reference Device
Manufacturer	InnoBioSurg Co., Ltd.	Neobiotech Co., Ltd.
Device Name	IBS System	CMI Implant IS System
Abutment Name	Magic Angled Abutment	IS Angled Abutment
510(k) No.	K220517	K181138
Material	TI-6AL-4V ELI	TI-6AL-4V ELI
Design	Image: [Subject Device Design]	Image: [Reference Device Design]
Diameter(⌀)	5.3
6.3	4.5, 5.2, 5.7, 6.5
Length(mm)	7.5, 8.03
7.73, 8.37	7.0, 8.0
Angle (°)	15, 23	15, 25
Surface Treatment	Machine-	Tin Coating
Sterilization	End User Sterilization	End User Sterilization
SE Discussion	The subject device is similar in indications for Use, fundamental scientific technology, principle of operation, technology, functions, and materials with the identified reference device.
The difference between the subject and reference device is the general design. However, it does not affect device's fundamental functions and safety; therefore, it is substantial equivalent.

	Subject Device	Reference Device	Reference Device
Manufacturer	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd	InnoBioSurg Co., Ltd.
Device Name	IBS System	CCM Abutment System	IBS Implant System II
Product Name	Magic Motion	UCLA Abutment	Magic motion
510(k) No.	K220517	K173120	K200753
Material	Ball Pin (TI-6AL-4V ELI)
Body (Co-Cr-Mo Alloy)	POM(Poly Acetal)
Co-Cr-Mo Alloy	Titanium Alloy
(ASTM F 136)
Design	Image: Subject Device Design	Image: Reference Device Design	Image: Reference Device Design

8

Diameters ( $ø$ )	4.0	4.0, 4.5, 5.0, 5.5	4.0
Total Length (mm)	10.61, 11.11, 11.56, 12.06,
12.11, 13.06, 13.11, 14.06,
14.11, 15.06	14.0, 15.0, 16.0, 17.0	10.05~16.05
Surface
Treatment	Machine-	N/A	Machine-
Sterilization	End User Sterilization	End User Sterilization	End User Sterilization
SE Discussion	The subject device is similar in indications for Use, fundamental scientific technology,
principle of operation, general design, technology, functions, and materials (Ball pin) with
the identified reference device.
The difference between the subject and reference device is the head(Ball Pin) shape
changed to more round. This difference is to improve the connection of Magic Motion and
Magic Motion Housing and doesn't impact product's substantial equivalence. And the
Body materials changed Co-Cr-Mo Alloy. To support the materials, K173120 was added
as a reference device. This difference is to improve strength doesn't affect device's
fundamental functions and safety; therefore, it is substantial equivalent.

	Subject Device	Reference Device
Manufacturer	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.
Device Name	IBS System	IBS Implant System II
Product Name	Magic Motion	Magic motion
510(k) No.	K220517	K200753
Material	TI-6AL-4V ELI	TI-6AL-4V ELI
Design	Image: Subject Device Design	Image: Reference Device Design
Diameters (⌀)	5.16	5.3
Total Length (mm)	3.3	3
Surface
Treatment	Machine-	Machine-
Sterilization	End User Sterilization	End User Sterilization
SE Discussion	The subject device is same in indications for Use, fundamental scientific technology,
principle of operation, general design, technology, functions, and materials with the
identified reference device.
The difference between the subject and reference device is diameters and length.
The height and diameter are changed from K200753 however, it doesn't impact product's
safety and effectiveness. Therefore, it is substantially equivalent.

9

	Subject Device	Primary Predicate	Reference Device
Manufacturer	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.
Device Name	IBS System	Magicore System	Magicore System
Product Name	Magic Abutment	Magic Abutment	Magicore
510(k) No.	K220517	K212517	K152520
Material	TI-6AL-4V ELI	TI-6AL-4V ELI	TI-6AL-4V ELI
Design	Image: Hex design
Image: Non-Hex design	Image: Hex design
Image: Non-Hex design	Image: Screw design
Diameters (Ø)	5.2, 5.7, 6.2, 6.7	5.2, 5.7, 6.2, 6.7	4.0, 4.5, 5.0, 5.5, 6.0, 6.5
Total Length(mm)	4.51, 5.51, 6.51, 7.51, 8.51	4.51, 5.51, 6.51, 7.51, 8.51	7.0~13.0
Surface Treatment	RBM(Blasting)	Machine-	RBM
Sterilization	End User Sterilization	End User Sterilization	Gamma Sterilization
SE Discussion
The subject device is same in fundamental scientific technology, technology, materials, dimensions, and design with the primary predicate.
The difference between the subject and primary device is the surface treatment and sterilization. To support these discrepancies, K152520 was added as reference device. The surface treatment between the subject device and K152520 is exactly same.
This surface change is intended to only improve scanning surface area and does not affect the actual equivalence of the product. Therefore, it is substantially equivalent.

|

Subject Device			Primary Predicate		Reference Device
Manufacturer	InnoBioSurg Co., Ltd.		InnoBioSurg Co., Ltd.		InnoBioSurg Co., Ltd.
Device Name	IBS Implant System		Magicore System		Magicore System
Product Name	Magic Abutment		Magic Abutment		Magicore
510(k) No.	K220517		K212517		K152520
Material	TI-6AL-4V ELI		TI-6AL-4V ELI		TI-6AL-4V ELI
Design	Image: Hex Design	Image: Non-Hex Design	Image: Hex Design	Image: Non-Hex Design	Image: Screw Design
	Hex	Non-Hex	Hex	Non-Hex
Diameters (ø)	5.2, 5.7, 6.2, 6.7		5.2, 5.7, 6.2, 6.7		4.0, 4.5, 5.0, 5.5, 6.0, 6.5
Total Length(mm)	6.5, 7.5, 8.5, 9.5, 10.5		6.5, 7.5, 8.5, 9.5, 10.5		7.0 ~13.0
Surface
Treatment	RBM(Blasting)		Machine-		RBM
Sterilization	End User Sterilization		End User Sterilization		Gamma Sterilization
SE Discussion	The subject device is same in fundamental scientific technology, technology, materials,
dimensions, and design with the primary predicate.
The difference between the subject and primary device is the surface treatment and
sterilization. To support these discrepancies, K152520 was added as reference device. The
surface treatment between the subject device and K152520 is exactly same.
This surface change is intended to only improve scanning surface area and does not affect
the actual equivalence of the product. Therefore, it is substantially equivalent.

10

	Subject Device	Reference Device	Reference Device
Manufacturer	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.
Device Name	IBS Implant System	Magicore System	Magicore System
Product Name	Magic Multiunit Abutment	Magic Multiunit Abutment	Magicore
510(k) No.	K220517	K212517	K152520
Material	TI-6AL-4V ELI	TI-6AL-4V ELI	TI-6AL-4V ELI
Design	Hex
Non-Hex	Hex
Non-Hex
Diameters (Ø)	4.8, 5.8	4.8, 5.8	4.0, 4.5, 5.0, 5.5, 6.0, 6.5
Angulation (°)	0, 5, 10, 15, 20, 25	0, 5, 10, 15, 20, 25	7.0~13.0
Surface
Treatment	RBM(Blasting)	Machine-	RBM
Sterilization	End User Sterilization	End User Sterilization	Gamma Sterilization
SE Discussion	The subject device is same in fundamental scientific technology, technology, materials,
dimensions and design with the primary predicate.
The difference between the subject and primary device is the surface treatment and
sterilization. To support these discrepancies, K152520 was added as reference device. The
surface treatment between the subject device and K152520 is exactly same.
This surface change is intended to only improve scanning surface area and does not affect the
actual equivalence of the product. Therefore, it is substantially equivalent.


	Subject Device	Reference Device	Reference Device
Manufacturer	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.
Device Name	IBS Implant System	Magicore System	Magicore System
Product Name	Magic Multiunit Cap	Magic Multiunit Cap	Magicore
510(k) No.	K220517	K212517	K152520
Material	TI-6AL-4V ELI	TI-6AL-4V ELI	TI-6AL-4V ELI
Design
Diameters (Ø)	5.4, 6.4	5.4, 6.4	4.0, 4.5, 5.0, 5.5, 6.0, 6.5
Total Length
(mm)	4.3	4.3	7.0~13.0
Surface
Treatment	RBM(Blasting)	Machine-	RBM
Sterilization	End User Sterilization	End User Sterilization	Gamma Sterilization

Magic Multiunit Abutmont(Co n

dimensions and design with the primary predicate. The difference between the subject and primary device is the surface treatment. SE Discussion To support these discrepancies, K152520 was added as reference device. The surface treatment between the subject device and K152520 is exactly same. This surface change is intended to only improve scanning surface area and does not affect the actual equivalence of the product. Therefore, it is substantially equivalent.

11

Non-Clinical Data:

Below tests were performed on the subject device:

End User Sterilization Validation Test Report on Abutments made of Titanium ELI with ● RBM(Blasting) Surface treatment according to ANSVAAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1
. Biocompatibility testing according to the ISO10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, and ISO 10993-10:2010 on abutments made of Titanium ELI with RBM(Blasting) Surface treatment.

Below tests were performed for predicate devices and leveraged for the subject device:

Biocompatibility testing according to ISO 10993-1:2009. ISO 10993-3:2014. ISO 10993-. 5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures referenced in K140806 & K162099
Biocompatibility testing according to ISO 10993-1:2009. ISO 10993-5:2009. ISO 10993-● 6:2007, and ISO 10993-10:2010 on abutments made of Titanium ELI referenced in K140806 & on Abutments made of CCM alloy referenced in K173120
LAL information/testing per USP as referenced in K162099
Sterilization validation for devices on Fixtures according to ISO 11137-1 and ISO 11137-2
. Shelf Life Test Report on Fixture and Magicore Cap according to ASTM F1980
End User Sterilization Validation Test Report on Abutments made of Titanium ELI according to . ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K192197
Fatigue Testing according to ISO 14801:2016 referenced in K212517 ●

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

The surface modification information with RBM (Resorbable Blasted media) and SLA(sand-blasted, large-grit, acid-etched)was provided. To compare surface modification between the subject and predicate devices, K152520 and K162099, surface roughness, surface composition analysis, and SEM imaging were provided, and it demonstrate the substantial equivalence.

The end user sterilization validation testing was performed on abutment made of Titanium ELI with RBM(Blasting) Surface treatment under the worst-case construction. This sterilization cycle has been validated by the overkill method to a sterility assurance level (SAL) of 10-6 according to ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The biocompatibility testing was performed on abutments made of Titanium ELI with RBM(Blasting) Surface treatment according to the ISO10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and it demonstrate the subject abutments are biocompatible.

Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments".

12

Performance testing of Fixture Packaging -
Below performance testing and information have been provided for subject implant fixture packaging:
Human Factors testing (A usability evaluation for aseptic presentation of the subject device, in line with ISO 11607-1:2019 and the recommendations of the FDA guidance document, "Applying Human Factors and Usability Engineering to Medical Devices.")
. Low and high magnification images at various degrees of rotation following the removal from the packaging (Evaluation of the broken tip at various degrees rotation at a high magnification and low magnification for damage after removal from the packaging and disconnection of the fixture jig)
. Quality System (QS) plan including the method and frequency of acceptance activities to ensure that the devices conform with product specifications with packaging design.

Conclusion

The IBS System, subject device of this submission, constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, IBS System and its predicates are substantially equivalent.