Predicate Devices

K162099, K140806, K202479, K152520, K192197, K161244

Reference Devices

K093321, K152520, K173120, K192197, K201981, K212517

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental implant system and its components, focusing on materials, intended use, and performance testing related to biocompatibility, sterilization, and mechanical properties. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No.
The device is a dental implant system used as an artificial root structure for tooth replacement, which serves a restorative and structural function rather than a therapeutic one (i.e., treating or curing a disease).

Diagnostic

No

The device is described as an "artificial root structure" for tooth replacement and consists of "dental implants, cylinders, caps and screws," indicating it is a prosthetic or restorative device, not one used for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of physical components like dental implants, cylinders, caps, and screws. The performance studies also focus on the physical properties and testing of these hardware components.

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 an "artificial root structure for single tooth replacement" and for "denture stabilization." This clearly indicates a surgical implant device used in vivo (within the body) for structural support and restoration.
Device Description: The description details dental implants, cylinders, caps, and screws, along with surface treatments (RBM, SLA). These are components of a surgical implant system, not a device used to test samples in vitro (outside the body).
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely structural and restorative within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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

DZE, NHA

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).

The fixtures and abutments in this system are:

Fixture
- Magicore Narrow (RBM)
- Magicore Narrow (SLA)
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

The fixture dimension range for Magicore Narrow - RBM and Magicore Narrow - SLA is:

3.0(Ø) X 11.0, 13.0, 15.0 (mm)
3.5(Ø) X 11.0, 13.0, 15.0 (mm)

The abutment features and dimension range are:

Closing Screw: Uses Closing Screw is placed flush over the top of the implant and the gum is sewn up over it for the period of healing. Diameters (Ø) 2.75, Length (mm) 5.2, Angle (°) 0, Surface Treatment Anodizing.
Short Abutment(Hex, Non-Hex): Uses The Abutment is connected with fixture and it supports prosthesis which restores tooth function. Diameters (Ø) 2.8, Length (mm) 4.2, 5.2, 6.2, 7.2, 8.2, Angle (°) 0, Surface Treatment N/A.
Magic Abutment(Hex, Non-Hex): Uses The Abutment is connected with fixture and it supports prosthesis which restores tooth function. Diameters (Ø) 3.87, Length (mm) 4.2, 5.2, 6.2, 7.2, 8.2, Angle (°) 0, Surface Treatment N/A.
Uses The Abutment is connected with fixture and it supports prosthesis which restores tooth function. Diameters (Ø) 4.5, Length (mm) 4.2, 5.2, 6.2, 7.2, 8.2, Angle (°) 0, Surface Treatment N/A.
Magicore Solid Abutment: Uses The Abutment is connected with fixture and it supports prosthesis which restores tooth function. Diameters (Ø) 2.8, Length (mm) 7.2, 8.2, 9.2, 10.2, 11.2, Angle (°) 0, Surface Treatment N/A.
Magicore Solid Abutment Cap: Uses The Abutment used to protect abutment inside of the mouth and minimize the feeling of irritation from the patient's mouth. Diameters (Ø) 4.5, Length (mm) 5.5, 6.5, 7.5, 8.5, 9.5, Angle (°) 0, Surface Treatment N/A.
Magicore Healing Cap: Uses Healing 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. Diameters (Ø) 4.6, 4.8, Length (mm) 5.5, 7.1, 8.0, Angle (°) 0, Surface Treatment N/A.
Magicore Healing Cap Screw: Uses Connection body to connect abutment to fixture. Diameters (Ø) 1.8, Length (mm) 6.4, Angle (°) 0, Surface Treatment N/A.
Abutment Screw: Uses Connection body to connect abutment to fixture. Diameters (Ø) 1.8, Length (mm) 7.0, Angle (°) 0, Surface Treatment N/A.

The subject fixtures are provided sterile. 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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Mandibular central and lateral incisors, maxillary lateral incisors, anterior mandible 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)

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 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 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.

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.

K161244

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.

K093321, K152520, K173120, K192197, K201981, K212517

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

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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

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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)

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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

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) | Angle
(°) | Surface
Treatment |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------|----------------------------|--------------|----------------------|
| Closing Screw | Closing Screw is placed flush over the
top of the implant and the gum is sewn
up over it for the period of healing. | 2.75 | 5.2 | 0 | Anodizing |
| Short
Abutment(Hex,
Non-Hex) | The Abutment is connected with
fixture and it supports prosthesis which
restores tooth function. | 2.8 | 4.2, 5.2, 6.2,
7.2, 8.2 | 0 | N/A |
| Magic
Abutment(Hex,
Non-Hex) | The Abutment is connected with
fixture and it supports prosthesis which
restores tooth function. | 3.87 | 4.2, 5.2, 6.2,
7.2, 8.2 | 0 | N/A |
| | The Abutment is connected with
fixture and it supports prosthesis which
restores tooth function. | 4.5 | 4.2, 5.2, 6.2,
7.2, 8.2 | 0 | N/A |

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| Magicore Solid
Abutment | The Abutment is connected with
fixture and it supports prosthesis which
restores tooth function. | 2.8 | 7.2, 8.2, 9.2,
10.2, 11.2 | 0 | N/A |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|------------------------------|---|-----|
| Magicore Solid
Abutment Cap | The Abutment used to protect
abutment inside of the mouth and
minimize the feeling of irritation from
the patient's mouth. | 4.5 | 5.5, 6.5, 7.5,
8.5, 9.5 | 0 | N/A |
| Magicore
Healing Cap | Healing 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. | 4.6, 4.8 | 5.5, 7.1, 8.0 | 0 | N/A |
| Magicore
Healing Cap
Screw | Connection body to connect abutment
to fixture. | 1.8 | 6.4 | 0 | N/A |
| Abutment
Screw | Connection body to connect abutment
to fixture. | 1.8 | 7.0 | 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)

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Summaries of Technological Characteristics & Substantial Equivalence Discussion

Fixtures

	Subject Device	Primary predicate	Reference Device
Manufacturer	InnoBioSurg Co., Ltd	Dentis Co., Ltd.	BioHorizons Implant
Systems. Inc
Device Name	Magicore Narrow System	s-Clean OneQ-SL Narrow
Implant System	BioHorizons Laser-Lok
3.0 Implant System
510(k) No.	K220079	K161244	K093321
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. | The s-Clean OneQ-SL Narrow
Implant System (3.0, 3.3mm)
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, 2) 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. | BioHorizons Laser-Lok 3.0
Implants 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 1) with
a temporary prosthesis that is
not in functional occlusion, 2)
when splinted together as an
artificial root structure for
multiple tooth replacement of
mandibular incisors, or 3) 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. |
| Design | Image: RBM | Image: SLA | Image: Implant |
| Material | Non-Cutting Edge
Ti-6Al-4V Eli | Cutting Edge
Ti-6Al-4V Eli | Non-Cutting Edge
Ti-6Al-4V Eli |
| Connection | Internal Hex
Non - Submerged | Internal Hex | Internal Hex |
| Endosseous
Implant | Tapered, macro threads | Tapered, macro threads | Tapered, macro threads |
| Platform
Diameters | $Ø$ 4.0 | - | - |
| Fixture
Diameters | $Ø$ 3.0, $Ø$ 3.5 | $Ø$ 3.0, $Ø$ 3.3 | $Ø$ 3.0 |
| Implantable
Lengths | 11.0, 13.0, 15.0 mm | 10.0, 12.0, 14.0 mm | 10.5, 12.0, 15.0 mm |
| Modified
Surface | R.B.M & S.L.A | S.L.A | R.B.M |

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| Surgical

Technique	1 and 2 stage, self-tapping	1 and 2 stage, self-tapping	1 and 2 stage, self-tapping
Gamma
Sterilization	Yes	Yes	Yes
SE Discussion	The Magicore Narrow System has similar device characteristics with the Primary predicate
such 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, the
longest implantable length and surface treatment (RBM) of the device. To support the Ø3.0
X15mm and the Ø3.5 X15mm long length and surface treatment (RBM), K093321 was added
as reference device. Any differences do not raise different questions of safety and
effectiveness 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 with
the 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 is
substantial equivalent.

	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: Hex
Image: Non-Hex	Image: Hex
Image: 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 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.

	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: Hex
Image: Non-Hex	Image: Hex
Image: 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 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. 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: Hex
Image: Non-Hex	Image: Hex
Image: 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. |

	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, 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.

	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 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.

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
Total
Lengths(mm)	5.5, 7.1, 8	4.5
Surface
Treatment	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 of
operation, general design, technology, functions, and materials with the identified reference
device.
The difference between the subject and reference device is the dimensions and surface
treatment of the device. However, it does not affect device's fundamental functions and
safety; 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
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 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.

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
Total
Lengths(mm)	7	5.2, 7.1
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 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.

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 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.