(66 days)
No
The summary describes a system of dental implants and related components, focusing on materials, design, and mechanical testing. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is intended to replace missing teeth to restore chewing function, which is a therapeutic purpose.
No
This device is intended to replace missing teeth and restore chewing function through the use of dental implants and abutments. It is a prosthetic device for treatment, not a diagnostic one.
No
The device description explicitly lists physical components such as fixtures, abutments, cylinders, caps, and screws made of materials like Ti 6AL 4V Eli. It also describes physical characteristics like the implant-abutment connection and surface treatment. This indicates it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "replacing missing teeth to restore chewing function." This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The description details dental implants, abutments, cylinders, caps, and screws, all components used in surgical procedures to replace teeth. These are physical devices implanted in the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Anatomical Site: The device is used in the "mandibles and maxillae," which are anatomical locations for dental procedures, not for collecting diagnostic samples.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore System can be placed in support of single or multiple-unit restorations including; cement retained, 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
This submission is to add new fixtures and abutments to the previously cleared device, Magicore System (K201981), Magicore II System (K201621), Magicore II System (K192197), and Magic UCLA Abutment System (K202418).
The fixtures and abutments in this system are below:
- Fixture
- Magicore
- Magicore (Cutting Edge)
- Abutment
- Magic Multiunit Abutment (Screw type - Hex, Non-Hex & Cemented type - Hex, Non-Hex)
- Magic Multiunit UCLA Cylinder
- Magic Multiunit Cap
- Magic Abutment (Screw type Hex, Non-Hex & Cemented type Hex, Non-Hex)
- Magic UCLA Cement Retained Type (Hex, Non-Hex)
- Magic Cylinder (Hex, Non-Hex, Post)
- Magic Multiunit Cylinder (Hex, Non-Hex, Post)
- Magicore Healing Cap
- Magicore Healing Cap Screw
- Cylinder 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 System consists of dental implants, Abutments, 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 implant is treated with RBM (Resorbable Blasted media).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No new additional non-clinical testing was performed for the subject device. The subject device compared to predicate device and reference devices are substantially equivalent in indications, fundamental technology, material, general design, and dimensions. Test reports of the predicate devices were leveraged for the subject device.
Tests performed for predicate devices and leveraged for the subject device:
- Sterilization validation for devices provided sterile per ISO 11137-1 and ISO 11137-2 referenced in K192197
- LAL information/testing per USP as referenced in K162099
- Shelf-Life Test on Fixtures according to ASTM F1980 referenced in K192197
- Biological assessment has been performed according to ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," and to the FDA Guidance document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff
- End User Sterilization Validation Test Report according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K192197
- Fatigue test report for devices according to ISO 14801 referenced in K192197
Key results: 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) was provided. To compare surface modification between the subject and predicate devices, K152520, surface roughness, surface composition analysis, and SEM imaging were provided, and it demonstrate the substantial equivalence. The fatigue testing per ISO 14801 was not required because the new worst case is not determined for the subject system.
Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K153639, K192197, K201621, K202418, K173120, K152520, K162099
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
October 15, 2021
InnoBioSurg Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K212517
Trade/Device Name: Magicore System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 10, 2021 Received: September 17, 2021
Dear April Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212517
Device Name Magicore System
Indications for Use (Describe)
The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore System can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Submitter
InnoBioSurg Co., Ltd. JongHyuk Seo 44-19, Techno 10-ro, Yuseong-gu Daejeon, 34027 Republic of Korea Email: jhseo@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 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: 10/14/2021 .
Predicate Devices:
The subject device is substantially equivalent to the following Reference Devices:
Primary Predicate K201981, Magicore System manufactured by InnoBioSurg Co., Ltd.
Reference Device K153639. OneO-SL s-Clean Implant System manufactured by Dentis Co., Ltd. K192197, Magicore II System manufactured by InnoBioSurg Co., Ltd. K201621, Magicore II System manufactured by InnoBioSurg Co., Ltd. K202418, Magic UCLA Abutment System manufactured by InnoBioSurg Co., Ltd.
Indications for Use
The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore System can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.
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Device Description
This submission is to add new fixtures and abutments to the previously cleared device, Magicore System (K201981), Magicore II System (K201621), Magicore II System (K192197), and Magic UCLA Abutment System (K202418).
The fixtures and abutments in this system are below:
- Fixture
- . Magicore
- Magicore (Cutting Edge) ●
2) Abutment
- . Magic Multiunit Abutment (Screw type - Hex, Non-Hex & Cemented type - Hex, Non-Hex)
- Magic Multiunit UCLA Cylinder ●
- Magic Multiunit Cap ●
- Magic Abutment (Screw type Hex, Non-Hex & Cemented type Hex, Non-Hex) ●
- Magic UCLA Cement Retained Type (Hex, Non-Hex)
- Magic Cylinder (Hex, Non-Hex, Post)
- Magic Multiunit Cylinder (Hex, Non-Hex, Post)
- Magicore Healing Cap ●
- Magicore Healing Cap Screw ●
- Cylinder 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 System consists of dental implants, Abutments, 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 implant is treated with RBM (Resorbable Blasted media).
Below is the fixture dimension range:
| Fixture | Platform
Diameters (Ø) | Fixture
Diameters (Ø) | Cuff
Lengths (mm) | Implantable
Lengths (mm) |
|-----------------------------------------------------------|---------------------------|-------------------------------------|----------------------|-----------------------------|
| Magicore
(Cleared in
K201981) | 5.2 | 4.0, 4.5 | 1, 2, 3, 4 | 7, 8, 9, 10, 11, 12, 13 |
| | 5.2 | 5.0, 5.5, 6.0, 6.5
(Newly Added) | | |
| | 5.7 | 4.5, 5.0, 5.5, 6.0, 6.5 | | |
| | 5.7 | 7.0, 7.5, 7.8
(Newly Added) | | |
| Magicore,
Cutting Edge type
(Cleared in
K201981) | 5.2 | 4.0, 4.5 | 1, 2, 3, 4 | |
| | 5.2 | 5.0, 5.5, 6.0, 6.5
(Newly Added) | | |
| | 5.7 | 4.5, 5.0, 5.5, 6.0, 6.5 | | |
| | 5.7 | 7.0, 7.5, 7.8
(Newly Added) | | |
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| Fixture
(Subject Device) | Platform
Diameter (Ø) | Fixture
Diameters (Ø) | Cuff
Lengths (mm) | Implantable
Lengths (mm) |
|---------------------------------|--------------------------|--------------------------|----------------------|-----------------------------|
| Magicore | 5.2 | 5.0, 5.5, 6.0, 6.5 | | 7, 8, 9, 10, 11, 12, 13 |
| | 5.7 | 7.0 | | 7, 8, 9, 10 |
| | | 7.5 | | 7,8,9 |
| | | 7.8 | | 7,8 |
| Magicore
(Cutting Edge type) | 5.2 | 5.0, 5.5, 6.0, 6.5 | 1, 2, 3, 4 | 7, 8, 9, 10, 11, 12, 13 |
| | 5.7 | 7.0 | | 7, 8, 9, 10 |
| | | 7.5 | | 7,8,9 |
| | | 7.8 | | 7,8 |
The subject fixtures are provided sterile.
The subject fixtures are compatible with the abutment in this submission and the abutments of K192197, K201621, K201981 and K202418.
Below is the abutment dimension range:
| Abutments | Diameters (Ø) | Length (mm) | Angulation (°) |
|---|---|---|---|
| Magic Multiunit Abutment | |||
| (Screw type - Hex, Non-Hex, | |||
| Cemented type – Hex, Non-Hex) | |||
| (Cleared in K201621) | 4.8, 5.8 | 1.5, 2.5, 3.5, 4.5 | 5, 10, 15, 20, 25 |
| 2.3 (Length Change) | 0 | ||
| (Newly Added) | |||
| Magic Multiunit UCLA Cylinder | |||
| (Cleared in K202418) | 4.5, 5.0, 5.2, 6.0, 6.2, 6.3 | 8.5, 8.75, 8.9, 10.2, 10.4, | |
| 10.5 | - | ||
| 5.4, 6.4 (Newly Added) | 11.2 (Newly Added) | ||
| Magic Cylinder | |||
| (Cleared in K201621) | 5.0, 6.0 | 10 | - |
| 10.6 (Length Change) | |||
| Magic Multiunit Cylinder | |||
| (Cleared in K201621) | 5.0, 6.0 | 10 | - |
| 5.4, 6.4 (Newly Added) | |||
| Magic Multiunit Cap | |||
| (Cleared in K192197) | 5.2, 6.2 | 4.5 | - |
| 5.4, 6.4 (Newly Added) | 4.3 (Newly Added) | ||
| Magic Abutment | |||
| (Screw type - Hex, Non-Hex, | |||
| Cement type - Hex, Non-Hex) | |||
| (Cleared in K192197) | 4.27, 4.7, 5.21, 5.5, 6.0 | 4.5, 5.5, 6.5, 7.5, 8.5 | |
| 4.6, 5.6, 6.6, 7.6, 8.6 | - | ||
| 5.2, 5.7, 6.2, 6.7 | |||
| (Newly Added) | 4.51, 5.51, 6.5, 6.51, 7.5, | ||
| 7.51, 8.5, 8.51, 10.5 | |||
| (Newly Added) | |||
| Magic UCLA Cement | |||
| Retained Type | |||
| (Cleared in K202418) | 4.5, 5.2, 6.2 | 8.5, 8.75, 8.9, 10.2, 10.4, | |
| 10.5 | - | ||
| 12.05, 12.85 | |||
| (Length Change) | |||
| Magicore Healing Cap | |||
| (Cleared in K192197) | 5.2, 6.2 | 4.5 | - |
| 5.3, 5.8, 6.3, 6.8 | |||
| (Newly Added) | 2.8, 3.8, 4.8, 5.8, 6.8 | ||
| (Newly Added) | |||
| Magicore Healing Cap Screw | 2.0 | 5.2, 7.1 |
6
| (Cleared in K173120) | | 5.4, 6.4, 7.4, 8.4, 9.4
(Newly Added) | |
|------------------------------------------------------------------------------------------|--------------------|------------------------------------------------------|----------------------|
| Cylinder Screw
(Cleared in K192197) | 2.0 | 5.2, 7.1 | - |
| | | 4.9 (Length Change), 7.1 | |
| Abutments (Subject Device) | Diameters (Ø) | Length (mm) | Angulation (°) |
| Magic Multiunit Abutment
(Screw type - Hex, Non-Hex,
Cemented type – Hex, Non-Hex) | 4.8, 5.8 | 2.3 | 0, 5, 10, 15, 20, 25 |
| Magic Multiunit UCLA Cylinder | 5.4, 6.4 | 11.2 | - |
| Magic Cylinder | 5.0, 6.0 | 10.6 | - |
| Magic Multiunit Cylinder | 5.0, 6.0, 5.4, 6.4 | 10 | - |
| Magic Multiunit Cap | 5.4, 6.4 | 4.3 | - |
| Magic Abutment
(Screw type - Hex, Non-Hex,
Cement type - Hex, Non-Hex) | 5.2, 5.7, 6.2, 6.7 | 4.51, 5.51, 6.5, 6.51, 7.5,
7.51, 8.5, 8.51, 10.5 | - |
| Magic UCLA Cement
Retained Type | 4.5, 5.2, 6.2 | 12.05, 12.85 | - |
| Magicore Healing Cap | 5.3, 5.8, 6.3, 6.8 | 2.8, 3.8, 4.8, 5.8, 6.8 | - |
| Magicore Healing Cap Screw | 2.0 | 5.4, 6.4, 7.4, 8.4, 9.4 | - |
| Cylinder Screw | 2.0 | 4.9, 7.1 | - |
The subject abutments are compatible with the fixtures in this submission and the fixtures of K192197 and K201981.
The abutments are provided non-sterile and packaged separately. The abutments should be sterilized before use.
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| Subject Device | Primary predicate | Reference Device | |
|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd | Dentis |
| Device Name | Magicore System | Magicore System | OneQ-SL s-Clean Implant System |
| 510(k) No. | N/A | K201981 | K153639 |
| Indications for use | The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore System can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading. | The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore System can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate Abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading. | The OneQ-SL s-Clean Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed 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. |
| Design | Image: Cutting Edge, Non-Cutting Edge | Image: Cutting Edge, Non-Cutting Edge | Image: Cutting Edge |
| Composition of Material | Titanium Alloy | ||
| Ti-6Al-4V Eli | |||
| ASTM F136 | Titanium Alloy | ||
| Ti-6Al-4V Eli | |||
| ASTM F136 | CP Titanium Grade 4 | ||
| (ASTM F67) | |||
| Connection | Internal Hex | ||
| Non - Submerged | Internal Hex | ||
| Non - Submerged | Internal Hex | ||
| Submerged | |||
| Endosseous Implant | Tapered, macro threads | Tapered, macro threads | Tapered & Straight Body |
| Platform Diameters (Ø) | 5.2 5.7 | 4.7 5.2 5.7 | Regular: 3.7, 3.9, 4.2, 4.7, 5.2 |
| Wide: 6.0, 7.0, 8.0 | |||
| Fixture Diameters (Ø) | 5.0, 5.5, 6.0, 6.5 7.0, 7.5, 7.8 | 4.0, 4.5, 5.0 4.0, 4.5 4.5, 5.0, 5.5, 6.0, 6.5 | |
| Cuff Lengths | |||
| (mm) | 1, 2, 3, 4 | 1, 2, 3, 4 | - |
| Neck Lengths | |||
| (mm) | 2 | 2 | - |
| Implantable | |||
| Lengths (mm) | 7, 8, 9, 10, | ||
| 11, 12, 13 | 7, 8, 9, 10, 11, 12, 13 | Regular: 7.8, 10, 12, 14 | |
| Wide: 7,8, 10, 12 | |||
| Thread pitch | 1.15P | 1.15P | - |
| Modified | |||
| Surface | R.B.M | R.B.M | S.L.A |
| Surgical | |||
| Technique | 1 and 2 stage, self-tapping | 1 and 2 stage, self-tapping | 3 sided cutting edge with |
| self-tapping | |||
| Gamma | |||
| Sterilization | Yes | Yes | Yes |
| SE Discussion | The Magicore System has same device characteristics with the Primary predicate (K201981) | ||
| such as intended use, material, functions, general shape (Design), surface treatment, structure | |||
| and applied production method. Platform/D 5.2 (Fixture/D 5.0,5.5,6.0.5,6.5) and P/D 5.7 | |||
| (F/D 7.0,7.5,7.8) was added in the Primary predicate device. | |||
| The subject fixture has bigger diameters such as 7.0, 7.5 and 7.8mm than the primary | |||
| predicate. To support this discrepancy, the reference device, K153639 was added and the | |||
| difference doesn't affect device's fundamental functions and safety since the diameter of the | |||
| subject device is within the range of the reference device's diameters. Therefore, the subject | |||
| device is substantial equivalent. |
Summaries of Technology Characteristics: 1) Fixture
8
9
2) Abutment
| Subject Device | Reference Device | |||
|---|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | ||
| Device Name | Magicore System | Magicore II System | ||
| Abutment Name | Magic Multiunit Abutment | Magic Multiunit Abutment | ||
| 510(k) No. | NA | K201621 | ||
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI | ||
| Design | Image: Hex | Image: Non-Hex | Image: Hex | Image: Non-Hex |
| Hex | Non-Hex | Hex | Non-Hex | |
| Diameters (Ø) | 4.8, 5.8 | 4.8, 5.8 | ||
| Gingiva Height (mm) | 2.3 | 1.5, 2.5, 3.5, 4.5 | ||
| Angulation (°) | 0 | 5, 10, 15, 20, 25 | ||
| Surface Treatment | Machine- | Machine- | ||
| Sterilization | End User Sterilization | End User Sterilization | ||
| SE Discussion | The subject device is same in indications for Use, fundamental scientific | |||
| technology, principle of operation, design, technology, functions, dimensions, and | ||||
| materials with the identified reference device. | ||||
| The Gingiva Height of previously cleared device (K201621) has changed. Also, | ||||
| the abutments with 0 ° angulation are added to the previously cleared device. Since | ||||
| the primary predicate's abutment is worst case (largest angulation), this difference | ||||
| does not impact product's safety and effectiveness. |
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | Magicore System | Magic UCLA Abutment System |
| Abutment Name | Magic Multiunit UCLA Cylinder | Magic UCLA Screw Retained Type |
| 510(k) No. | NA | K202418 |
| Material | Co-Cr-Mo Alloy | |
| Poly Diacetate | Co-Cr-Mo Alloy | |
| Poly Diacetate | ||
| Design | Image: Two abutment designs, one white and one black | Image: Two abutment designs, both white |
| Diameters (Ø) | 5.4, 6.4 | 4.5, 5.0, 5.2, 5.5, 6.0, 6.2, 6.3 |
| Length (mm) | 11.2 | 8.5, 8.75, 8.9, 10.2, 10.4, 10.5 |
| Surface Treatment | Machine- | Machine- |
| Sterilization | End User Sterilization | End User Sterilization |
10
| SE Discussion | The subject device is same in indications for use, material, fundamental scientific
technology, principle of operation, design, technology, functions with the identified
reference device.
The differences between the subject and reference device are the design and
dimensions. 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 System | Magicore II System |
| Abutment Name | Magic Multiunit Cap | Magic Multiunit Abutment Cap |
| 510(k) No. | NA | K192197 |
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameters ( $\varnothing$ ) | 5.4, 6.4 | 5.2, 6.2 |
| Length (mm) | 4.3 | 4.5 |
| Surface Treatment | Machine- | Machine- |
| Sterilization | End User Sterilization | End User Sterilization |
| SE Discussion | The subject device is same in indications for use, fundamental scientific | |
| technology, principle of operation, general design, technology, functions, and | ||
| materials with the identified reference device. | ||
| The differences between the subject and reference device are the design and | ||
| dimensions. 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 System | Magicore II System |
| Abutment Name | Magic Abutment | Magic Abutment |
| 510(k) | N/A | K192197 |
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI |
| Design | Image: Hex | |
| Image: Non-Hex | Image: Hex | |
| Image: Non-Hex | ||
| Diameters (Ø) | 5.2, 5.7, 6.2, 6.7 | 4.27, 4.7, 5.21, 5.5, 6.0 |
| Lengths(mm) | 4.51, 5.51, 6.5, 6.51, 7.5, 7.51, 8.5, | |
| 8.51, 9.5, 10.5 | 4.5, 5.5, 6.5, 7.5, 8.5, | |
| 4.6, 5.6, 6.6, 7.6, 8.6 |
11
| Surface
| Treatment | Machine- | Machine- |
|---|---|---|
| Sterilization | End User Sterilization | End User Sterilization |
| SE Discussion | The subject device is same in indications for Use, fundamental scientific | |
| technology, principle of operation, general design, technology, functions, and | ||
| materials with the identified reference device. | ||
| The difference between the subject and reference device is the design and lengths | ||
| of the device. However, it does not affect device's fundamental functions and | ||
| safety; therefore, it is substantial equivalent. | The subject device is same in indications for Use, fundamental scientific | |
| technology, principle of operation, general design, technology, functions, and | ||
| materials with the identified reference device. | ||
| The difference between the subject and reference device is the design and lengths | ||
| of the device. However, it does not affect device's fundamental functions and | ||
| safety; therefore, it is substantial equivalent. |
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | Magicore System | Magic UCLA Abutment System |
| Abutment Name | Magic UCLA Cement Retained Type | Magic UCLA Cement Retained Type |
| 510(k) No. | NA | K202418 |
| Material | Co-Cr-Mo Alloy | |
| Poly Diacetate | Co-Cr-Mo Alloy | |
| Poly Diacetate | ||
| Design | Image: Hex | |
| Image: Non-Hex | Image: Hex | |
| Image: Non-Hex | ||
| Diameters (Ø) | 4.5, 5.2, 6.2 | 4.5, 5.0, 5.2, 5.5, 6.0, 6.2, 6.3 |
| Length (mm) | 12.05, 12.85 | 8.5, 8.75, 8.9, 10.2, 10.4, 10.5 |
| Surface Treatment | Machine- | Machine- |
| Sterilization | End User Sterilization | End User Sterilization |
| SE Discussion | The subject device is same in indications for Use, fundamental scientific | |
| technology, principle of operation, general design, technology, functions, and | ||
| materials with the identified reference device. | ||
| The difference between the subject and reference device is the lengths of the | ||
| device. However, it does not affect device's fundamental functions and safety; | ||
| therefore, it is substantial equivalent. | The subject device is same in indications for Use, fundamental scientific | |
| technology, principle of operation, general design, technology, functions, and | ||
| materials with the identified reference device. | ||
| The difference between the subject and reference device is the lengths of the | ||
| device. However, it does not affect device's fundamental functions and safety; | ||
| therefore, it is substantial equivalent. |
12
| Subject Device | Primary Predicate | |
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | Magicore System | Magicore II System |
| Abutment Name | Magic Cylinder | Magic Multiunit Abutment ST |
| 510(k) No. | NA | K201621 |
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI |
| Design | Image: Hex, Non-Hex, Post | Image: Hex, Non-Hex, Post |
| Diameters (Ø) | 5.0, 6.0 | 5.0, 6.0 |
| Length (mm) | 10.6 | 10 |
| Surface Treatment | Machine- | Machine- |
| Sterilization | End User Sterilization | End User Sterilization |
| SE Discussion | The product name of the cleared Magic Multiunit Abutment ST (K201621) is | |
| changed into the Magic Cylinder. Also, the lengths of the Magic Cylinder is | ||
| changed. The subject device is same in indications for Use, fundamental scientific | ||
| technology, principle of operation, general design, technology, functions, and | ||
| materials with the identified reference device. | ||
| The difference between the subject and reference device is the lengths of the | ||
| device. However, it does not affect device's fundamental functions and safety; | ||
| therefore, it is substantial equivalent. |
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | Magicore System | Magicore II System |
| Abutment Name | Magic Multiunit Cylinder | Magic Multiunit Cylinder |
| 510(k) No. | NA | K201621 |
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI |
| Design | Image: Hex Image: Non-Hex Image: Post | Image: Hex Image: Non-Hex Image: Post |
13
| Diameters (Ø) | 5.0, 5.4, 6.0, 6.4 | 5.0, 6.0 |
|---|---|---|
| Length (mm) | 10 | 10 |
| Surface Treatment | Machine- | Machine- |
| Sterilization | End User Sterilization | End User Sterilization |
| SE Discussion | The subject device is same in indications for Use, fundamental scientific | |
| technology, principle of operation, general design, technology, functions, and | ||
| materials with the identified reference device. | ||
| The difference between the subject and reference device is the diameters of the | ||
| device. However, it does not affect device's fundamental functions and safety; | ||
| therefore, it is substantial equivalent. |
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Company | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | Magicore System | Magicore II System | Magicore II System |
| Abutment Name | Magicore Healing Cap | Healing Cap | Magic Multiunit Abutment |
| Cap | |||
| 510(k) Number | N/A | K201981 | K192197 |
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI | TI-6AL-4V ELI |
| Design | Image: Design of Subject Device | Image: Design of Primary Predicate | Image: Design of Reference Device |
| Diameters (Ø) | 5.3, 5.8, 6.3, 6.8 | 5.3, 5.5, 6.0, 6.3, 6.5, 6.9, 7.6 | 5.2, 6.2 |
| Lengths(mm) | 2.8, 3.8, 4.8, 5.8, 6.8 | 2.8, 4.2, 5.3 | 4.5 |
| Surface | |||
| Treatment | Machine- | Anodizing | |
| (Green, Purple, Blue, Yellow) | Machine | ||
| Sterilization | End user Sterilization | End user Sterilization | End user Sterilization |
| SE Discussion | The subject device is same in indications for Use, fundamental scientific technology, | ||
| principle of operation, general design, technology, functions, and materials with the | |||
| identified reference device. | |||
| The difference between the subject and primary predicate device is the design and | |||
| dimensions of the device. To support the design difference discrepancy, K192197 was | |||
| added. However, it does not affect device's fundamental functions and safety; therefore, | |||
| it is substantial equivalent. |
14
| Subject Device | Reference Device | |
|---|---|---|
| Company | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | Magicore System | CCM Abutment System |
| Abutment Name | Magicore Healing Cap Screw | Abutment Screw |
| 510(k) Number | N/A | K173120 |
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameters ( $ \varnothing $ ) | 2.0 | 2.0 |
| Lengths(mm) | 5.4, 6.4, 7.4, 8.4, 9.4 | 5.2, 7.1 |
| Surface | ||
| Treatment | Machine | Machine |
| Sterilization | End user Sterilization | End user Sterilization |
| SE Discussion | The subject and Reference Device have similar indications for use, functions, materials, | |
| surface treatment, general shape (design). | ||
| The difference between the subject and reference device is the design and lengths 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 System | Magicore II System |
| Abutment Name | Cylinder Screw | Abutment Screw |
| 510(k) Number | N/A | K192197 |
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI |
| Design | ||
| Diameters (Ø) | 2.0 | 2.0 |
| Lengths(mm) | 4.9, 7.1 | 5.2, 7.1 |
| Surface | ||
| Treatment | Machine | Machine |
| Sterilization | End user Sterilization | End user Sterilization |
| SE Discussion | The subject and Reference Device have similar indications for use, functions, materials, | |
| surface treatment, general shape (design). | ||
| The difference between the subject and reference device is the lengths of the device. | ||
| However, it doesn't affect device's fundamental functions and safety; therefore, it is | ||
| substantial equivalent. |
15
Non-Clinical Data:
No need to perform any new additional non-clinical testing for the subject device since the subject device compared to predicate device and reference devices are substantially equivalent in indications. fundamental technology, material, general design, and dimensions. Any test reports of the predicate devices may be leveraged for the subject devices because the same materials, manufacturing methods, and sterilization procedures. Although the dimensions are slightly different, it does not impact the ability to determine substantial equivalence of the subject devices because the predicate devices are the worst case based on the product's dimensional comparison analysis provided.
Below tests were performed for predicate devices and leveraged for the subject device:
- Sterilization validation for devices provided sterile per ISO 11137-1 and ISO 11137-2 ● referenced in K192197
- LAL information/testing per USP as referenced in K162099 ●
- Shelf-Life Test on Fixtures according to ASTM F1980 referenced in K192197 ●
- Biological assessment has been performed according to ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," and to the FDA Guidance document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff
- End User Sterilization Validation Test Report according to ANSI/AAMI ST79, ISO 17665-1, ● ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K192197
- Fatigue test report for devices according to ISO 14801 referenced in K192197 ●
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) was provided. To compare surface modification between the subject and predicate devices, K152520, surface roughness, surface composition analysis, and SEM imaging were provided, and it demonstrate the substantial equivalence. The fatigue testing per ISO 14801 was not required because the new worst case is not determined for the subject system.
Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments".
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.