The Magicore Narrow System (3.0, 3.5mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
The implants may be restored immediately

with a temporary prosthesis that is not in functional occlusion,
when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
for denture stabilization using multiple implants in the anterior mandible and maxilla.
The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Device Description

The Magicore Narrow System consists of dental implants, cylinders, caps and screws for use in one or two-stage dental implant placement and restorations. The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the Magicore Narrow implant is treated with RBM (Resorbable Blasted media) or SLA(sand-blasted, large-grit, acid-etched).

AI/ML Overview

This document is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. For dental implants, substantial equivalency is typically demonstrated through engineering and material characteristic comparisons to predicate devices, and performance testing, rather than clinical studies with patient outcomes. Therefore, the questions typically associated with clinical studies (like sample size for test sets, number of experts for ground truth, MRMC studies, training set details, etc.) are not directly applicable in the context of this 510(k) summary.

The manufacturer is demonstrating substantial equivalence by comparing the "Magicore Narrow System" to several predicate and reference devices. The acceptance criteria and the "study" proving the device meets these criteria are primarily based on comparative technical characteristics and non-clinical performance testing, rather than a clinical trial with human subjects.

Here's a breakdown based on the provided document, addressing the closest equivalents to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The term "acceptance criteria" here refers to demonstrating that the new device's characteristics and performance are substantially equivalent to legally marketed predicate devices, meaning they do not raise new questions of safety or effectiveness. The performance is "reported" by showing that the subject device's features align with or are within acceptable ranges of the predicate devices, and by outlining non-clinical tests performed.

Characteristic/Test Area	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Summary of Equivalence and Testing)
Indications for Use	Must be substantially equivalent to predicate devices to ensure similar intended clinical application.	The Magicore Narrow System (3.0, 3.5mm) has identical indications for use as the primary predicate (s-Clean OneQ-SL Narrow Implant System, K161244) and a reference device (BioHorizons Laser-Lok 3.0 Implant System, K093321): used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors; immediate restoration with temporary prosthesis not in functional occlusion; splinted for multiple tooth replacement of mandibular incisors; or for denture stabilization using multiple implants in anterior mandible and maxilla. Implants may be placed in immediate function when good primary stability and appropriate occlusal loading are achieved.
Materials	Must use biocompatible materials that are commonly accepted for dental implants and are equivalent to predicate devices.	Fixtures and most abutments are made of Ti-6Al-4V ELI (Conforming to ASTM Standard F-136), identical to predicate devices. The Magicore Solid Abutment Cap is made of PolyOxyMethylene (=Acetal).
Design Characteristics	Fixture and abutment design characteristics (e.g., connection type, surface treatment, diameters, lengths) should be within a clinically acceptable range compared to predicate devices, or differences must be justified as not raising new safety/effectiveness concerns.	Fixtures:- Inner Connection: Internal hex, non-submerged (similar to predicates).- Endosseous Implant: Tapered, macro threads (similar to predicates).- Platform Diameters: Ø 4.0.- Fixture Diameters: Ø 3.0, Ø 3.5 (similar to predicates, with Ø 3.3 for one predicate and Ø 3.0 for another).- Implantable Lengths: 11.0, 13.0, 15.0 mm (longer lengths supported by reference device K093321).- Modified Surface: RBM & SLA (Primary predicate K161244 uses SLA; reference device K093321 uses RBM. Differences justified).- Surgical Technique: 1 and 2 stage, self-tapping (similar to predicates).Abutments: Various abutments (Closing Screw, Short Abutment, Magic Abutment, Magicore Solid Abutment, Magicore Solid Abutment Cap, Magicore Healing Cap, Healing Cap Screw, Abutment Screw) are compared to various reference devices (K152520, K192197, K212517, K201981, K173120). Differences in dimensions (diameters, lengths) are noted but justified as not affecting fundamental functions or safety due to similarity in intended use, fundamental scientific technology, principle of operation, general design, technology, functions, and materials.
Sterilization	Device must be sterile or sterilizable, and sterilization methods must be validated and equivalent to predicate devices.	Fixtures are provided sterile via Gamma sterilization (similar to predicates). Closing Screw and Magicore Healing Cap also Gamma sterilized. Other abutments are provided non-sterile for end-user sterilization, with validation tested to ANSVAAMI ST79, ISO 17665-1/2, ISO 11737-1/2, ISO 11138-1 (leveraged from predicate K202479 and K140806).
Biocompatibility	Device materials must be biocompatible.	Biocompatibility testing for fixtures (ISO 10993-1, 3, 5, 6, 10, 11) and abutments made of Titanium ELI (ISO 10993-1, 5, 6, 10) was leveraged from predicates (K140806 & K162099), demonstrating equivalence with same materials and manufacturing processes.
Non-Clinical Performance	Mechanical and packaging integrity must be demonstrated as safe and effective.	Shelf Life: Tested for subject fixtures according to ASTM F1980 (results met criteria).LAL Testing: Performed for subject fixtures according to USP <85> (referenced in K140806 & K162099, results met criteria).Surface Modification Analysis: Surface roughness, surface composition analysis, and SEM imaging compared between subject (RBM and SLA surfaces) and predicate devices (K152520 and K192197) to demonstrate substantial equivalence.MR Environment Condition: Non-clinical worst-case MRI review performed using scientific rationale and published literature, addressing magnetically induced displacement force and torque based on FDA guidance.Fixture Packaging Performance: Human Factors testing (usability evaluation for aseptic presentation per ISO 11607-1:2019 and FDA guidance), low and high magnification imaging after removal from packaging to check for damage, and Quality System plan for packaging acceptance activities were provided. Results indicated devices conform to product specifications with packaging design.

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

This document is a 510(k) summary for a dental implant, which does not typically involve a "test set" or "training set" of patient data in the way an AI/ML device would. Instead, substantial equivalence is demonstrated through comparative engineering data and non-clinical performance testing.

Sample Size for Testing: The document refers to various standards (e.g., ASTM F1980, ISO 11137-1/2, USP <85>, ANSV/AAMI ST79 series, ISO 17665-1/2, ISO 11737-1/2, ISO 11138-1, ISO 10993 series) for non-clinical performance tests. The specific sample sizes for these engineering tests are not detailed in this summary but would be part of the full test reports. For example, biomechanical tests (fatigue, static strength) are typically conducted with small sample sizes (e.g., n=5 or n=10 per group, as per ISO standards for implants).
Data Provenance: The data comes from non-clinical laboratory testing performed by the manufacturer (InnoBioSurg Co., Ltd.) or leveraged from testing performed for predicate devices from other manufacturers. Data is implicitly prospective in the sense that the manufacturer conducted these tests for this specific submission or leveraged existing valid test data from similar devices. The country of origin for the non-clinical data is not specified but the manufacturer is based in the Republic of Korea.

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

Not applicable. "Ground truth" in the context of clinical expert consensus for image-based diagnostic or prognostic devices is not relevant for this type of medical device (dental implant). Substantial equivalence is based on engineering and material standards, and comparison to already-cleared predicate devices. The "experts" would be the engineers and quality assurance professionals who conducted and reviewed the non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the sense of reconciling differences in expert annotations or diagnoses, as this is not a diagnostic device relying on human interpretation of complex data.

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

No. An MRMC comparative effectiveness study is not performed for dental implants. These studies are typically conducted for AI/ML-driven diagnostic or screening devices to assess how the AI assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm-based diagnostic device.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

Engineering Standards: Compliance with recognized international and national standards for medical devices and dental implants (e.g., ASTM, ISO standards for materials, sterilization, biocompatibility, mechanical properties).
Predicate Device Equivalence: The established safety and effectiveness of legally marketed predicate devices. The "ground truth" is that if the new device is sufficiently similar to a predicate device in termsally relevant characteristics (and any differences do not raise new safety/performance questions), then it is considered safe and effective.
Non-Clinical Test Results: Data from physical, chemical, mechanical, and biological (biocompatibility) tests proving that the device meets specified performance requirements outlined in the relevant standards.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device requiring data to learn patterns.

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

Not applicable, as there is no training set.

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.

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

Re: K220079

Trade/Device Name: Magicore Narrow System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 10, 2022 Received: November 14, 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew I. Steen -S

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

Enclosure

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

Indications for Use

510(k) Number (if known) K220079

Device Name Magicore Narrow System

Indications for Use (Describe)

The Magicore Narrow System (3.0, 3.5mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

with a temporary prosthesis that is not in functional occlusion,
when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or

1. for denture stabilization using multiple implants in the anterior mandible and maxilla.
  The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

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

510(K) Summary

Submitter

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

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

Device Information

Trade Name: Magicore Narrow 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: 12/13/2022

Predicate Devices:

The subject device is substantially equivalent to the following Devices:

Primary Predicate K161244, s-Clean OneO-SL Narrow Implant System manufactured by Dentis Co., Ltd.

Reference Device

K093321, BioHorizons Laser-Lok 3.0 Implant System by BioHorizons Implant

K152520, Magicore System manufactured by InnoBioSurg Co., Ltd.

K173120, CCM Abutment System manufactured by InnoBioSurg Co., Ltd.

K192197, Magicore II System manufactured by InnoBioSurg Co., Ltd.

K201981, Magicore System manufactured by InnoBioSurg Co., Ltd.

K212517, Magicore System manufactured by InnoBioSurg Co., Ltd.

Indications for Use

The Magicore Narrow System (3.0, 3.5mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

with a temporary prosthesis that is not in functional occlusion,
when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

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

Device Description:

The fixtures and abutments in this system are below:

1. Fixture
- Magicore Narrow (RBM) ●
- . Magicore Narrow (SLA)
1. Abutment
- Short Abutment(Hex, Non-Hex) ●
- Magicore Solid Abutment
- Magic Abutment (Hex, Non-Hex) ●
- Magicore Solid Abutment Cap
- Magicore Healing Cap ●
- Magicore Healing Cap Screw
- Closing Screw ●
- Abutment Screw ●

An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The Magicore Narrow System consists of dental implants, cylinders, caps and screws for use in one or two-stage dental implant placement and restorations. The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the Magicore Narrow implant is treated with RBM (Resorbable Blasted media) or SLA(sand-blasted, large-grit, acid-etched).

Below is the fixture dimension range:

Fixture	Fixture Diameters (Ø) X Implantable Lengths (mm)
Magicore Narrow -RBM	3.0(Ø) X 11.0, 13.0, 15.0 (mm)3.5(Ø) X 11.0, 13.0, 15.0 (mm)
Magicore Narrow -SLA	3.0(Ø) X 11.0, 13.0, 15.0 (mm)3.5(Ø) X 11.0, 13.0, 15.0 (mm)

The subject fixtures are provided sterile.

Below is the abutment Features and dimension range:

Abutments	Uses	Diameters(Ø)	Length (mm)	SurfaceTreatment
Closing Screw	Closing Screw is placed flush over thetop of the implant and the gum is sewnup over it for the period of healing.	2.75	5.2	Anodizing
ShortAbutment(Hex,Non-Hex)	The Abutment is connected withfixture and it supports prosthesis whichrestores tooth function.	2.8	4.2, 5.2, 6.2,7.2, 8.2	N/A
MagicAbutment(Hex,Non-Hex)	The Abutment is connected withfixture and it supports prosthesis whichrestores tooth function.	3.87	4.2, 5.2, 6.2,7.2, 8.2	N/A
	The Abutment is connected withfixture and it supports prosthesis whichrestores tooth function.	4.5	4.2, 5.2, 6.2,7.2, 8.2	N/A

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

Magicore SolidAbutment	The Abutment is connected withfixture and it supports prosthesis whichrestores tooth function.	2.8	7.2, 8.2, 9.2,10.2, 11.2	N/A
Magicore SolidAbutment Cap	The Abutment used to protectabutment inside of the mouth andminimize the feeling of irritation fromthe patient's mouth.	4.5	5.5, 6.5, 7.5,8.5, 9.5	N/A
MagicoreHealing Cap	Healing caps lead to accurate closureof soft tissue surrounding implant andprovide a definite shape and form togingiva which is aesthetically close tonatural look.	4.6, 4.8	5.5, 7.1, 8.0	N/A
MagicoreHealing CapScrew	Connection body to connect abutmentto fixture.	1.8	6.4	N/A
AbutmentScrew	Connection body to connect abutmentto fixture.	1.8	7.0	N/A

The Closing Screw, Magicore Healing Cap are supplied sterile by Gamma sterilization. Other abutments are provided non-sterile and packaged separately. The abutments should be sterilized before use by End User sterilization.

The Magicore Narrow Fixture is only compatible with the Magicore Narrow Abutments.

Materials:

Magicore Narrow Fixture and abutments are made of Ti-6A1-4V Eli -
-Magicore Solid Abutment Cap is made of PolyOxyMethylene(=Acetal)

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

Summaries of Technological Characteristics & Substantial Equivalence Discussion

Fixtures

	Subject Device	Primary predicate	Reference Device
Manufacturer	InnoBioSurg Co., Ltd	Dentis Co., Ltd.	BioHorizons ImplantSystems. Inc
Device Name	Magicore Narrow System	s-Clean OneQ-SL NarrowImplant System	BioHorizons Laser-Lok3.0 Implant System
510(k) No.	K220079	K161244	K093321
Indicationsfor use	The Magicore Narrow System(3.0, 3.5mm) may be used as anartificial root structure for singletooth replacement of mandibularcentral and lateral incisors andmaxillary lateral incisors.The implants may be restoredimmediately1) with a temporary prosthesisthat is not in functional occlusion,2) when splinted together as anartificial root structure formultiple tooth replacement ofmandibular incisors, or3) for denture stabilization usingmultiple implants in the anteriormandible and maxilla.The implants may be placed inimmediate function when goodprimary stability has beenachieved and with appropriateocclusal loading.	The s-Clean OneQ-SL NarrowImplant System (3.0, 3.3mm)may be used as an artificial rootstructure for single toothreplacement of mandibularcentral and lateral incisors andmaxillary lateral incisors. Theimplants may be restoredimmediately1) with a temporary prosthesisthat is not in functionalocclusion, 2) when splintedtogether as an artificial rootstructure for multiple toothreplacement of mandibularincisors, or3) for denture stabilization usingmultiple implants in the anteriormandible and maxilla.The implants may be placed inimmediate function when goodprimary stability has beenachieved and with appropriateocclusal loading.	BioHorizons Laser-Lok 3.0Implants may be used as anartificial root structure forsingle tooth replacement ofmandibular central and lateralincisors and maxillary lateralincisors. The implants may berestored immediately 1) witha temporary prosthesis that isnot in functional occlusion, 2)when splinted together as anartificial root structure formultiple tooth replacement ofmandibular incisors, or 3) fordenture stabilization usingmultiple implants in theanterior mandible andmaxilla. The implants may beplaced in immediate functionwhen good primary stabilityhas been achieved and withappropriate occlusal loading.
Design	Image: RBM	Image: SLA	Image: Implant
Material	Non-Cutting EdgeTi-6Al-4V Eli	Cutting EdgeTi-6Al-4V Eli	Non-Cutting EdgeTi-6Al-4V Eli
Connection	Internal HexNon - Submerged	Internal Hex	Internal Hex
EndosseousImplant	Tapered, macro threads	Tapered, macro threads	Tapered, macro threads
PlatformDiameters	$Ø$ 4.0	-	-
FixtureDiameters	$Ø$ 3.0, $Ø$ 3.5	$Ø$ 3.0, $Ø$ 3.3	$Ø$ 3.0
ImplantableLengths	11.0, 13.0, 15.0 mm	10.0, 12.0, 14.0 mm	10.5, 12.0, 15.0 mm
ModifiedSurface	R.B.M & S.L.A	S.L.A	R.B.M

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

SurgicalTechnique	1 and 2 stage, self-tapping	1 and 2 stage, self-tapping	1 and 2 stage, self-tapping
GammaSterilization	Yes	Yes	Yes
SE Discussion	The Magicore Narrow System has similar device characteristics with the Primary predicatesuch as Indications for use, functions, material, surface treatment (SLA), fixture diameter,surgical technique, sterilization method, structure and applied production method.The difference between the subject device and primary predicate are device design, thelongest implantable length and surface treatment (RBM) of the device. To support the Ø3.0X15mm and the Ø3.5 X15mm long length and surface treatment (RBM), K093321 was addedas reference device. Any differences do not raise different questions of safety andeffectiveness than the primary predicate; therefore, it is substantial equivalent.

Abutment

	Subject Device	Reference Device
Manufacturer	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.
Device Name	Magicore Narrow System	Magicore System
Abutment Name	Closing Screw	Closing Screw
510(k) No.	K220079	K152520
Material	TI-6AL-4V ELI	TI-6AL-4V ELI
Design	Image: Subject Device Design	Image: Reference Device Design
Diameters (Ø)	2.75	3.5
Total Length (mm)	5.2	5.65
Surface Treatment	Anodizing (Light Green)	Machined & Anodizing (Yellow, Purple,Blue, Green)
Sterilization	Gamma Sterilization	Gamma Sterilization
SE Discussion	The subject device is similar in intended use, fundamental scientific technology,principle of operation, general design, technology, functions, material, anodizing withthe cover screw cleared in K152520.The difference between the subject and reference device is dimension of the device.However, it does not affect device's fundamental functions and safety; therefore, it issubstantial equivalent.

< Short Abutment ( Hex, Non-Hex)>

	Subject Device	Reference Device
Manufacturer	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.
Device Name	Magicore Narrow System	Magicore II System
Abutment Name	Short Abutment	Short Abutment
510(k) No.	K220079	K192197
Material	TI-6AL-4V ELI	TI-6AL-4V ELI
Design	Image: HexImage: Non-Hex	Image: HexImage: Non-Hex

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

Diameters (ø)	2.8	3.5, 3.86, 4.3, 4.6
Total Length (mm)	4.2, 5.2, 6.2, 7.2, 8.2	4.55, 5.55, 6.55, 7.55, 8.55
Surface Treatment	Machine-	Machine-
Sterilization	End User Sterilization	End User Sterilization
SE Discussion	The subject device is similar in intended use, fundamental scientific technology,principle of operation, design, technology, functions, dimensions, and materials with theidentified reference device.The difference between the subject and reference device is the dimensions of the device.However, it does not affect device's fundamental functions and safety; therefore, it issubstantial equivalent.

< Magic Abutment (Hex, Non-Hex)>

	Subject Device	Reference Device
Company	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.
Device Name	Magicore Narrow System	Magicore II System
Abutment Name	Magic Abutment	Magic Abutment
510(k)	K220079	K192197
Material	TI-6AL-4V ELI	TI-6AL-4V ELI
Design	Image: HexImage: Non-Hex	Image: HexImage: Non-Hex
Diameters (∅)	3.87	4.57, 4.7, 5.07, 5.57, 5.7, 5.87, 6.2, 6.37, 6.5, 7.0
Total Lengths(mm)	4.2, 5.2, 6.2, 7.2, 8.2	4.27, 5.21, 5.5, 6.0
Surface Treatment	Machine-	Machine-
Sterilization	End User Sterilization	End User Sterilization
SE Discussion	The subject device is similar in intended use, fundamental scientific technology,principle of operation, design, technology, functions, dimensions, and materials withthe identified reference device.The difference between the subject and reference device is the dimensions of thedevice. However, it does not affect device's fundamental functions and safety;therefore, it is substantial equivalent. SMAH5506AS

	Subject Device	Reference Device
Company	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.
Device Name	Magicore Narrow System	Magicore System
Abutment Name	Magic Abutment	Magic Abutment
510(k)	K220079	K212517
Material	TI-6AL-4V ELI	TI-6AL-4V ELI
Design	Image: HexImage: Non-Hex	Image: HexImage: Non-Hex
Diameters (Ø)	4.5	5.2, 5.7, 6.2, 6.7
Total Lengths(mm)	4.2, 5.2, 6.2, 7.2, 8.2	4.51, 5.51, 6.5, 6.51, 7.5, 7.51, 8.5, 8.51,9.5, 10.5
Surface Treatment	Machine-	Machine-
Sterilization	End User Sterilization	End User Sterilization

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

SE Discussion	The subject device is similar in intended use, fundamental scientific technology,principle of operation, design, technology, functions, dimensions, and materials
	with the identified reference device.
	The difference between the subject and reference device is the dimensions of the
	device. However, it does not affect device's fundamental functions and safety;
	therefore, it is substantial equivalent.

< Magicore Solid Abutment>

	Subject Device	Reference Device
Manufacturer	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.
Device Name	Magicore Narrow System	Magicore System
Abutment Name	Magicore Solid Abutment	Magicore Solid Abutment
510(k) No.	K220079	K201981
Material	TI-6AL-4V ELI	TI-6AL-4V ELI
Design	Image: Design of subject device	Image: Design of reference device
Diameters (Ø)	2.8	3.5, 3.86, 4.3, 4.6
Total Length (mm)	7.2, 8.2, 9.2, 10.2, 11.2	7.6, 8.6, 9.6, 10.6, 11.6
Surface Treatment	Machine-	Machine-
Sterilization	End User Sterilization	End User Sterilization
SE Discussion	The subject device is similar in intended use, fundamental scientific technology, principleof operation, design, technology, functions, dimensions, and materials with the identifiedreference device.The difference between the subject and reference device is the dimensions of the device.However, it does not affect device's fundamental functions and safety; therefore, it issubstantial equivalent.

	Subject Device	Reference Device
Manufacturer	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.
Device Name	Magicore Narrow System	Magicore System
Abutment Name	Magicore Solid Abutment Cap	Magicore Solid Abutment Cap
510(k) No.	K220079	K201981
Material	PolyOxyMethylene (=Acetal)	PolyOxyMethylene (=Acetal)
Design	Image: Subject Device Design	Image: Reference Device Design
Diameters (Ø)	4.5	5.5, 6.0, 6.5, 7.0
Total Length (mm)	5.5, 6.5, 7.5, 8.5, 9.5	5.5, 6.5, 7.5, 8.5, 9.5
Sterilization	End User Sterilization	End User Sterilization
SE Discussion	The subject device is similar in intended use, fundamental scientific technology,principle of operation, design, technology, functions, dimensions, and materials withthe identified reference device.The difference between the subject and reference device is the dimensions of thedevice. However, it does not affect device's fundamental functions and safety;therefore, it is substantial equivalent.

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

	Subject Device	Reference Device
Company	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.
Device Name	Magicore Narrow System	Magicore System
Abutment Name	Magicore Healing Cap	Healing Cap
510(k) Number	K220079	K201981
Material	TI-6AL-4V ELI	TI-6AL-4V ELI
Design	Image: Subject Device Design	Image: Reference Device Design
Diameters (Ø)	4.6, 4.8	5.3, 5.5, 6.0, 6.3, 6.5, 6.9, 7.6
TotalLengths(mm)	5.5, 7.1, 8	4.5
SurfaceTreatment	Machine-	Anodizing(Green, Purple, Blue, Yellow)
Sterilization	End User Sterilization	End User Sterilization
SE Discussion	The subject device is similar in intended use, fundamental scientific technology, principle ofoperation, general design, technology, functions, and materials with the identified referencedevice.The difference between the subject and reference device is the dimensions and surfacetreatment of the device. However, it does not affect device's fundamental functions andsafety; therefore, it is substantial equivalent.

	Subject Device	Reference Device
Company	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.
Device Name	Magicore Narrow System	CCM Abutment System
Abutment Name	Magicore Healing Cap Screw	Abutment Screw
510(k) Number	K220079	K173120
Material	TI-6AL-4V ELI	TI-6AL-4V ELI
Design	Image: Subject Device Design	Image: Reference Device Design
Diameters (∅)	1.8	2.0
Total Lengths(mm)	6.4	5.2, 7.1
SurfaceTreatment	Machine	Machine
Sterilization	End user Sterilization	End user Sterilization
SE Discussion	The subject device is similar in intended use, fundamental scientific technology,principle of operation, design, technology, functions, dimensions, and materials with theidentified reference device.The difference between the subject and reference device is the dimensions of the device.However, it does not affect device's fundamental functions and safety; therefore, it issubstantial equivalent.

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

	Subject Device	Reference Device
Company	InnoBioSurg Co., Ltd.	InnoBioSurg Co., Ltd.
Device Name	Magicore Narrow System	CCM Abutment System
Abutment Name	Abutment Screw	Abutment Screw
510(k) Number	K220079	K173120
Material	TI-6AL-4V ELI	TI-6AL-4V ELI
Design	Image: Abutment Screw	Image: Abutment Screw
Diameters ( $Ø$ )	1.8	2.0
TotalLengths(mm)	7	5.2, 7.1
SurfaceTreatment	Machine	Machine
Sterilization	End user Sterilization	End user Sterilization
SE Discussion	The subject device is similar in intended use, fundamental scientific technology, principleof operation, design, technology, functions, dimensions, and materials with the identifiedreference device.The difference between the subject and reference device is the dimensions of the device.However, it does not affect device's fundamental functions and safety; therefore, it issubstantial equivalent.

Non-Clinical Data:

Below tests were performed on subject device:

Shelf Life for subject fixtures according to ASTM F1980 ●
Below tests were performed for predicate devices and leveraged for the subject device:
Sterilization validation for subject fixtures according to ISO 11137-1 and ISO 11137-2 ● referenced in K162099 & K140806
LAL information/testing for subject fixtures according to USP <85> as referenced in K140806 ● & K162099
End User Sterilization Validation Test Report according to ANSVAAMI ST79, ISO 17665-1, . ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 for subject abutments made of Titanium ELI referenced in K202479
. End User Sterilization Validation Test Report according to ANSV/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 for subject abutments made of PolyOxyMethylene referenced in K140806
Biocompatibility testing for subject Fixtures 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 referenced in K140806 & K162099
Biocompatibility testing for subject abutments made of Titanium ELI according to ISO 10993-. 1:2009, ISO 10993-5:2009, ISO 10993-6:2007, and ISO 10993-10:2010 referenced in K140806

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

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

devices, K152520 and K192197, surface roughness, surface composition analysis, and SEM imaging were provided, and it demonstrate the substantial equivalence.

The Sterilization validation test were performed on K162099 for fixtures and cover screws with the same material, sterilization method, packaging method, and manufacturing process as the subject device.

The end user sterilization test was performed for predicate device and leveraged for the subject device because the product category, material, manufacturing process, facility, and packaging of both products are exactly same.

The Biocompatibility Test was conducted on the predicate device and leveraged for the subject device because both products are manufactured with same materials and manufacturing process. It demonstrates that the subject device is biocompatible and substantial equivalence with the predicate.

-MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the Magicore Narrow System devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental 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.
-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 (OS) plan including the method and frequency of acceptance activities to ensure that the devices conform with product specifications with packaging design.

Conclusion

The Magicore Narrow 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, Magicore Narrow System and its predicates are substantially equivalent.

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.