Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard dental implant system and does not mention any AI or ML components or capabilities.

Therapeutic

No
The device is described as an endosseous dental implant system intended to replace missing teeth and restore chewing function, which is a restorative rather than therapeutic purpose.

Diagnostic

No
The Magicore System is intended to replace missing teeth and restore chewing function, which is a therapeutic purpose, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components made of materials like Ti 6AL 4V Eli, including dental implants, abutments, and screws. It also mentions surface treatments and sterilization, indicating a hardware-based device.

IVD (In Vitro Diagnostic)

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

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, abutments, and screws, which are physical components used for surgical implantation and restoration.
Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or condition.
Performance Studies: The performance studies focus on non-clinical tests related to the physical properties, sterilization, biocompatibility, and shelf-life of the device, not on diagnostic accuracy or performance.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Magicore System is an in vivo (within the body) device used for surgical implantation and restoration.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore 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

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 System is consists of dental implants, abutments, 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 system has been treated with RBM (Resorbable Blasted media).

The Fixture diameters are 4, 4.5, 5, 5, 6, 6.5mm and lengths are 7, 9, 11, 13mm in this system. The contained various abutments and accessories in the system are abutment screw, magicore abutment &cap, healing cap (color anodizing: yellow, blue, green, and purple). The abutments are provided straight only and that they are no intended to be modified to provide an angle correction.

Fixtures and abutments are packaged separately. The Fixtures are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Mandibles and maxillae (implied by "edentulous mandibles and maxillae" in predicate device description)

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 tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments". Sterilization Validation testing performed in accordance with ISO 11137-1:2006, ISO 11137-2:2006 and surface treatment analysis were used to support the decision of substantial equivalence.

A biocompatibility evaluation was conducted and since all the materials were used in the company's own predicate or conform to an FDA consensus standard, no additional biocompatibility testing was deemed necessary.

Shelf-life validation was conducted on the packaging of the sterile device according to ASTM 1980 to validate the 5 year shelf life via real-time aging.

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

Not Found

Predicate Device(s)

K073247

Reference Device(s)

K140806

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

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, composed of three interconnected profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 25, 2016

InnoBioSurg Co., Ltd. c/o Ms. April Lee Consultant WithUS Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K152520

Trade/Device Name: Magicore System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: December 16, 2015 Received: December 22, 2015

Dear Ms. 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. 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

Page 2 - Ms. April Lee

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K152520

Device Name Magicore System

Indications for Use (Describe)

The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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3

Image /page/3/Picture/1 description: The image shows the logo for IBS Implant Innobiosurg Co., Ltd. The logo features a stylized letter "G" in blue with a yellow accent at the top left. Next to the "G" is the text "IBS" in bold, blue letters, followed by "implant" in a smaller font. Below "implant" is the text "Innobiosurg Co.,Ltd" in a smaller, lighter font.

InnoBioSt

44-19. Techno 10-ro. Yuseong-gu. Daeieon. 305-510. Korea Tel. 82- 42-933-2879 / Fax. 82-42-933-2881

510(k) Summary

Submitter

InnoBioSurg Co., Ltd. Bo-reumYoo 44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510 Republic of Korea Email: bryoo@ibsimplant.com Tel.+82-42-933-2879 Fax.+82-42-933-2881

Official Correspondent

WithUS Group Inc April Lee 2531 Pepperdale Drive Rowland Heights, CA 91748 USA Email:withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

Trade Name: Magicore System
Common Name: Dental Implant System
Classification Name: Endosseous dental implant
Primary Product Code: DZE
Secondary Product Code: NHA
. Panel: Dental
Regulation Number: 872.3640
Device Class: Class II
Date prepared: 1/22/2016

General Description

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 System is consists of dental implants, abutments, 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 system has been treated with RBM (Resorbable Blasted media).

The Fixture diameters are 4, 4.5, 5, 5, 6, 6.5mm and lengths are 7, 9, 11, 13mm in this system. The contained various abutments and accessories in the system are abutment screw, magicore abutment &cap, healing cap (color anodizing: yellow, blue, green, and purple). The abutments are provided straight only and that they are no intended to be modified to provide an angle correction.

Fixtures and abutments are packaged separately. The Fixtures are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use.

Indication for Use

The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore 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 and not for immediate loading. This system is intended for delayed loading.

4

Image /page/4/Picture/0 description: The image shows the logo for IBS implant. The logo consists of the letters "IBS" in a bold, dark blue font, with a yellow dot above the "I". To the right of "IBS" is the word "implant" in a smaller, dark blue font. Below "implant" is the text "Innobiosurg Co.,Ltd" in a smaller, light yellow font.

Materials:

The dental implants are fabricated from Ti 6AL 4V Eli (Conforming to ASTM Standard F-136).

Non-Clinical Data:

Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments". Sterilization Validation testing performed in accordance with ISO 11137-1:2006, ISO 11137-2:2006 and surface treatment analysis were used to support the decision of substantial equivalence.

A biocompatibility evaluation was conducted and since all the materials were used in the company's own predicate or conform to an FDA consensus standard, no additional biocompatibility testing was deemed necessary.

Shelf-life validation was conducted on the packaging of the sterile device according to ASTM 1980 to validate the 5 year shelf life via real-time aging.

Predicate Device:

1) Comparison to Predicate Devices: (implant)

. K073247, US/SS/GS SYSTEM manufactured by OSSETEM Implant Co., Ltd.
(Reference Device) K140806, IBS Implant System manufactured by Innobiosurg Co., Ltd.

	Subject device	Predicate device	Reference device
Product Name	Magicore System	US/SS/GS SYSTEM	IBS Implant System
510(k)
Product code
Class	K152520
DZE,NHA
II	K073247
DZE
II	K140806
DZE/NHA
II
Manufacturer	InnoBioSurg Co., Ltd.	OSSETEM Co., Ltd.	InnoBioSurg Co., Ltd.
Indication for
use	The Magicore System
is intended to replace
missing teeth to restore
chewing function. The
Magicore can be placed
in support of single or
multiple-unit
restorations including;	Intended for use in partially
or fully edentulous
mandible sand maxillae, in
support of single or
multiple-unit restorations
including; cement-
retained, screw- retained,
oroverdenture restorations	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-
	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.	And terminal or
intermediate
Abutment support for
fixed bridgework. This
system is dedicated
For one and two stage
surgical procedures and not
dedicated
For immediate loading.
This system is intended for
Delayed
loading.	retained, or
overdenture restorations, and
terminal or immediate
abutment support for fixed
bridgework. This system is
for one or two stage surgical
procedures and not for
immediate loading. This
system is intended for delayed
loading.
Design	Image: Implant 1	Image: Implant 2	Image: Implant 3
Composition
of Material	Titanium Alloy
Ti-6Al-4V Eli
ASTM F136	Titanium Alloy
Ti-6A1-4V Eli
ASTM F136	Titanium Alloy
Ti-6A1-4V Eli
ASTM F136
Neck Length	1,2,3mm	1.8mm, 2.8mm
Fixture Type	NON Submerged	NON Submerged	Submerged
Endosseous
Implant	Tapered,
macro threads	Tapered,
Macro threads	Tapered, macro and
micro threads
Components	Various abutments
and accessories	Various abutments
and accessories	Various abutments
and accessories
Range of
Diameters
(mm)	4, 4.5, 5, 5.5, 6,
6.5mm	4.0 - 6.0mm	3.8, 4.3, 4.8, 5.3, 5.8,6.3 mm
Range of
Lengths(mm)	7 mm - 13 mm	7 mm - 13 mm	7 mm – 15 mm
Modified
Surface	R.B.M.	R.B.M.	R.B.M.
Surgical
Technique	1 stage and 2 stage,
self tapping	1 stage and 2 stage,
self tapping	1 stage and 2 stage, self
tapping
Gamma
Sterilization	Yes	Yes	Yes
Body Contact	Direct	Direct	Direct
Contact
Duration	Class C (>30days)	Class C (>30days)	Class C (>30days)
	Subject device	Predicate device	Reference device
Product Name	Magicore System	US/SS/GS SYSTEM	IBS Implant System
510(k)
Product code
Class	K152520
DZE/NHA
II	K073247
DZE
II	K140806
DZE/NHA
II
Manufacturer	InnoBioSurg Co., Ltd.	OSSETEM Co., Ltd.	InnoBioSurg Co., Ltd.
Indication for
use	The Magicore System is
intended to replace
missing teeth to restore
chewing function. The
Magicore 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.	Intended for use in partially
or fully edentulous
mandibles and maxillae, in
support of single or
multiple-unit restorations
including ;cement-
retained, screw- retained,
or overdenture restorations,
and terminal or
intermediate abutment
support for fixed
bridgework. This system is
dedicated
For one and two stage
surgical procedures and not
dedicated for immediate
loading. This system is
intended for delayed loading.	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 and not
for immediate loading. This
system is intended for delayed
loading.
Abutment
design	Image: Abutment design	Image: Abutment design	Image: Abutment design
Diameter	3.5, 3.86, 4.3, 4.6mm		4.0, 4.5, 5.0, 5.5, 6.0,
6.5mm
length	9.6, 10.6, 11.6mm		10.6, 11.6, 12.6, 13.6, 14.6,
15.6mm
Healing cap
Design	Image: Healing cap design 1	Image: Healing cap design 2	Image: Healing cap design 3
Diameter	5.5mm		4.0, 4.5, 5.0, 5.5, 6.0mm
length	7.3mm		9.1, 10.1, 11.1, 12.1, 13.1,
14.1mm
Abutment cap
design	Image: Abutment cap design 1	Image: Abutment cap design 2	Image: Abutment cap design 3
diameter	5.5, 6.0, 6.5, 7.0mm		4.5, 5.0, 5.5, 6.0, 6.5,
7.0mm
length	5.5, 6.5, 7.5, 8.5,
9.5mm		5.1, 6.6, 8.1mm
Closing screw
design	Image: Closing screw design 1	Image: Closing screw design 2	Image: Closing screw design 3
diameter	3.5mm		3.4mm
length	5.65mm		5.65mm
Composition
of Material	Titanium Alloy
Ti-6Al-4V Eli
ASTM F136	Titanium Alloy
Ti-6Al-4V Eli
ASTM F136	Titanium Alloy
Ti-6Al-4V Eli
ASTM F136
Materials of
Magicore
Abutment
Cap	PolyDiacetate	Polycarbonate polymer	PolyDiacetate
Contact
Duration	Class C (>30days)	Class C (>30days)	Class C (>30days)

5

Image /page/5/Picture/0 description: The image shows the logo for IBS implant. The logo consists of the letters "IBS" in a bold, sans-serif font, followed by the word "implant" in a smaller, italicized font. Below the word "implant" is the text "Innobiosurg Co.,Ltd" in a smaller font. The logo is primarily blue, with a small yellow accent on the "I".

InnoBioSurg Co., Ltd.
44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Korea
11 Tel. 82-42-933-2879 / Fax. 82-42-933-2881

6

Image /page/6/Picture/0 description: The image shows the logo for IBS implant. The logo consists of the letters "IBS" in a bold, sans-serif font, with a small yellow circle above the "I" and a blue square around the "I". To the right of "IBS" is the word "implant" in a smaller, sans-serif font. Below "implant" is the text "Innobiosurg Co.,Ltd" in a smaller, lighter font.

InnoBioSurg Co., Ltd.
44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Korea
14-19, Tel. 82- 42-933-2879 / Fax. 82-42-933-2881

2) Comparison chart for abutments

7

Image /page/7/Picture/0 description: The image shows the logo for IBS implant. The logo consists of a stylized letter "i" and "G" in blue, followed by the text "IBS implant" in a bold, dark blue font. Below the word "implant" is the text "Innobiosurg Co.,Ltd" in a smaller, lighter font.

InnoBioSurg Co., Ltd.
44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Korea
11 Tel. 82-42-933-2879 / Fax. 82-42-933-2881

8

Image /page/8/Picture/0 description: The image shows the logo for IBS implant. The logo consists of the letters "IBS" in a bold, sans-serif font, with the "I" having a yellow square in the upper left corner. To the right of "IBS" is the word "implant" in a smaller, sans-serif font. Below "implant" is the text "Innobiosurg Co.,Ltd" in an even smaller, sans-serif font.

Substantial Equivalence Discussion

The indications for use, material, general shape design, surface, connection to abutment method, application method and sterilization method between the Magicore System and the predicate devices are similar.

The differences between them are the external shape of the fixture and fixture diameters.

The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use or substantial equivalence.

Any differences between the Mazicore System and predicate device do not raise new types of safety or effectiveness issues. Accordingly we can claim the substantially equivalence of the Magicore System to predicate device.

Conclusion

The Magicore 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 System and its predicates are substantially equivalent.