(259 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to replace missing teeth and restore chewing function, which addresses a health issue and aims to improve a physiological function.
No
Explanation: The device, Magicore II System, is described as an endosseous dental implant system intended to replace missing teeth and restore chewing function. Its components are physical implants and associated parts for surgical procedures and restorations, not for diagnosing conditions.
No
The device description explicitly lists physical components made of materials like Ti 6AL 4V Eli, including dental implants, cylinders, caps, and screws. The performance studies also focus on physical properties like fatigue and biocompatibility. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "replace missing teeth to restore chewing function." This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a dental implant system, consisting of physical components designed to be surgically implanted into the jawbone. This is a medical device, not a diagnostic reagent or instrument used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances or markers, or providing information for diagnosis, monitoring, or screening.
The information provided clearly describes a dental implant system used for surgical and restorative procedures, which falls under the category of a medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Magicore II System is intended to replace missing teeth to restore chewing function. The Magicore II System can be placed in support of single or 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 II 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 II implant is treated with SLA (sand-blasted, large-grit, acid-etched). The Fixture diameters are 4.0, 4.5, 5.0, 5.5, 6.0, 6.5mm and threaded lengths are 7, 8, 9, 10, 11, 12, 13mm in this system.
The contained various abutments and screws in the system are Short Abutment, Magic Multi Abutment, Magic Multi Cylinder, Magic Multi Abutment ST, Abutment Screw, Healing Cap, Magicore Angled Abutment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw arches
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)
- Fatigue Testing: performed on the subject device under the worstcase scenario and its result is strong enough to achieve their intended use.
- 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.
- Sterilization validation: for devices provided sterile per ISO 11137-1 and ISO 11137-2 referenced in K152520.
- LAL information/testing: per USP as referenced in K162099.
- Shelf Life Test: on Healing Abutments according to ASTM F1980 referenced in K152520.
- Biocompatibility testing: according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993- 5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures referenced in K140806, K152520 and K162099.
- Biocompatibility testing: according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, and ISO 10993-10:2010 on abutments referenced in K152520 and K173120.
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K072570, K080594, K150344, K153350, K160670, K161689, K162099, K171027, K173120, K173575
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 28, 2020
InnoBioSurg Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K192197
Trade/Device Name: Magicore II System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 23, 2020 Received: April 27, 2020
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 (OS) 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
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192197
Device Name Magicore II System
Indications for Use (Describe)
The Magicore II System is intended to replace missing teeth to restore chewing function. The Magicore II System can be placed in support of single or 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) |
|| | 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 K192197
Submitter
InnoBioSurg Co., Ltd. Eun-Ji Yoo 44-19 , Techno 10-ro, Yuseong-gu Daejeon, 34027 Republic of Korea Email: ejyoo@ibsimplant.com Tel. +82-42-933-2879 Fax. +82-42-933-2881
Device Information
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
- Trade Name: Magicore II System
- Common Name: Endosseous Dental Implant
- Classification Name: Implant, Endosseous, Root-Form
- Product Code: DZE
- . Secondary Product Code: NHA
- Panel: Dental
- . Regulation Number: 21 CFR 872.3640
- Device Class: Class II
- . Date prepared: April 26, 2020
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
K152520, Magicore System manufactured by InnoBioSurg Co., Ltd.
Reference Device
K072570, Nobelactive Multi Unit Abutment by Nobel Biocare AB K080594, MS System (Narrow Ridge) by Osstem Implant Co., Ltd.
K150344, Dentis Dental Implant System by Dentis Co., Ltd.
K153350. IBS Implant System manufactured by InnoBioSurg Co., Ltd.
K160670, ET US SS Prosthetic system by Osstem Implant Co., Ltd.
K161689, OSSTEM Implant System - Abutment by Osstem Implant Co., Ltd.
K162099, IBS Implant System II manufactured by InnoBioSurg Co., Ltd.
K171027, Dentis Dental Implant System by Dentis Co., Ltd.
K173120, CCM Abutment System manufactured by InnoBioSurg Co., Ltd.
K173575. OsteoReady Dental Implant System by OsteoReady LLC.
4
K192197
Indication for Use:
The Magicore II System is intended to replace missing teeth to restore chewing function. The Magicore II System can be placed in support of single or 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.
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 II 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 II implant is treated with SLA (sand-blasted, large-grit, acid-etched). The Fixture diameters are 4.0, 4.5, 5.0, 5.5, 6.0, 6.5mm and threaded lengths are 7, 8, 9, 10, 11, 12, 13mm in this system.
The contained various abutments and screws in the system are Short Abutment, Magic Multi Abutment, Magic Multi Cylinder, Magic Multi Abutment ST, Abutment Screw, Healing Cap, Magicore Angled Abutment.
| Abutments | Diameters (Ø) | Lengths (mm) |
|---|---|---|
| Short Abutment (Hex, Non-Hex) | 3.5, 3.86, 4.3, 4.6 | 4.55, 5.55, 6.55, 7.55, 8.55 |
| Magic Abutment (Hex, Non-Hex) | 4.57, 4.7, 5.07, 5.57, 5.7, 5.87, | |
| 6.2, 6.37, 6.5, 7.0 | 4.5, 5.5, 6.5, 7.5, 8.5 | |
| 4.27, 5.21, 5.5, 6.0 | ||
| Magic Multi Abutment | ||
| (Screw type – Hex, Non-Hex, Cemented type – | ||
| Hex, Non-Hex) | 4.8 | 4.6, 5.6, 6.6, 7.6, 8.6 |
| 4.6, 5.6, 6.6, 7.6, 8.6 | ||
| 5, 6, 7, 8 | ||
| 5.2, 6.2, 7.2, 8.2 | ||
| 5.8 | 4.7, 5.7, 6.7, 7.7, 8.7 | |
| 5.1, 6.1, 7.1, 8.1 | ||
| 5.3, 6.3, 7.3, 8.3 | ||
| Magic Multi Cylinder (Hex, Non-Hex, Post) | 5.0, 6.0 | 10 |
| Magic Multi Abutment ST (Hex, Non-Hex, Post) | 5.0, 6.0 | 10 |
| Healing Cap | 5.2, 6.2 | 4.5 |
| Magicore Angled Abutment | 4.3 | 11.2, 12.2, 13.2, 14.2 |
| Abutment Screw | 2 | 5.2, 7.1 |
The dimension ranges of the abutments are below:
Tolerance of dimension for Fixtures and Abutments shall be within ± 1% range.
Fixtures and abutments are packaged separately. The Fixtures are supplied sterile and the abutments and screw are provided non-sterile. The abutments and screw should be sterilized before use.
Materials:
- Fixtures are fabricated from Ti-6AI-4V Eli (Conforming to ASTM Standard F-136).
- Short Abutment, Magic Abutment, Magic Multi Abutment, Magic Multi Cylinder, Magic Multi Abutment ST, Abutment Screw, Healing Cap, Magicore Angled Abutment are fabricated from Ti-6Al-4V Eli (Conforming to ASTM Standard F-136).
5
Summaries of Technology Characteristics:
1) Fixture
| Subject Device | Primary Predicate | Reference Device | Reference Device | Subject Device | Reference Device | Reference Device | Subject Device | Reference Device | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Product Name | Magicore II System | Magicore System | IBS Implant System II | MS System (Narrow Ridge) | Company | InnoBioSurg Co., Ltd. | Dentis Co., Ltd. | OsteoReady LLC | Company | InnoBioSurg Co., Ltd. | Osstem Co., Ltd. | |
| 510(k) | ||||||||||||
| Product code | ||||||||||||
| Class | N/A | |||||||||||
| DZE | ||||||||||||
| II | K152520 | |||||||||||
| DZE | ||||||||||||
| II | K162099 | |||||||||||
| DZE | ||||||||||||
| II | K080594 | |||||||||||
| DZE | ||||||||||||
| II | Device Name | Magicore II System | Dentis Dental Implant System | OsteoReady Dental Implant System | Device Name | Magicore II System | SS System | |||||
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd. | OSSTEM IMPLANT CO.,LTD | 510(k) | N/A | K171027 | K173575 | 510(k) Number | N/A | K160670 | |
| Indications for | ||||||||||||
| use | The Magicore II System is | |||||||||||
| intended to replace missing teeth | ||||||||||||
| to restore chewing function. The | ||||||||||||
| Magicore II System can be placed | ||||||||||||
| in support of single or 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 | ||||||||||||
| 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 IBS Implant System II is | |||||||||||
| intended to replace missing teeth to | ||||||||||||
| restore chewing function. | ||||||||||||
| The IBS Implant System II 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 MS System (Narrow Ridge) is | |||||||||||
| intended to use in the treatment of | ||||||||||||
| missing mandibular central and | ||||||||||||
| lateral incisors to support prosthetic | ||||||||||||
| device, such as artificial teeth, in | ||||||||||||
| order to restore chewing function in | ||||||||||||
| partially edentulous patients. MS | ||||||||||||
| System (Narrow Ridge) are | ||||||||||||
| intended for single use only and not | ||||||||||||
| for immediate loading. | Indications | |||||||||||
| for Use | The Magicore II System is intended to | |||||||||||
| replace missing teeth to restore chewing | ||||||||||||
| function. The Magicore II System can be | ||||||||||||
| placed in support of single or 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 Dentis Dental Implant System is an endosseous | |||||||||||
| dental implant that is indicated for surgical | ||||||||||||
| placement in the upper and lower jaw arches, to | ||||||||||||
| provide a root form means for single or multiple- | ||||||||||||
| units prosthetic appliance attachment to restore a | ||||||||||||
| patient's chewing function. Implants can be placed | ||||||||||||
| with a conventional two stage surgical process with | ||||||||||||
| an option for transmucosal healing or they can be | ||||||||||||
| placed in a single stage surgical process for | ||||||||||||
| immediate loading when good primary stability has | ||||||||||||
| been achieved and with appropriate occlusal loading. | OsteoReady® Dental Implant System is | |||||||||||
| indicated for use in surgical and | ||||||||||||
| restorative applications for placement in | ||||||||||||
| the bone of the upper or lower jaw to | ||||||||||||
| provide support for prosthetic devices, | ||||||||||||
| such as artificial teeth, in order to | ||||||||||||
| restore the patient's chewing function. | ||||||||||||
| RidgeReady® 3.0 implants are intended | ||||||||||||
| to replace a lateral incisor in the maxilla | ||||||||||||
| and/or a central or lateral incisor in the | ||||||||||||
| mandible. | Indications for Use | The Magicore II System is intended to replace missing teeth to | ||||||||||
| restore chewing function. The Magicore II System can be | ||||||||||||
| placed in support of single or 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. | ET System | |||||||||||
| The HIOSSEN Prosthetic system is intended for use with | ||||||||||||
| a dental implant to provide support for prosthetic | ||||||||||||
| restorations such as crowns, bridges, or over-dentures. | ||||||||||||
| US/SS System | ||||||||||||
| The OSSTEM Prosthetic system is intended for use with | ||||||||||||
| a dental implant to provide support for prosthetic | ||||||||||||
| restorations such as crowns, bridges, or over-dentures. | ||||||||||||
| Design | Image: Magicore II System Design | Image: Magicore System Design | Image: IBS Implant System II Design | |||||||||
| NR Fix | ||||||||||||
| Image: IBS Implant System II Design | ||||||||||||
| Magic FC | Image: MS System (Narrow Ridge) Design | Material | TI-6AL-4V ELI | Pure Titanium( Grade 4 ) | Ti-6Al-4V-ELI | Material | TI-6AL-4V ELI | TI-6AL-4V ELI | ||||
| 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 | Titanium Alloy | |||||||||||
| Ti-6Al-4V Eli | ||||||||||||
| ASTM F136 | Design | Image: Magicore II System design | Image: Dentis Dental Implant System design | Image: OsteoReady Dental Implant System design | Design | Image: Magicore II System design | Image: Osstem System design | |||||
| Connection | Internal Hex | |||||||||||
| Non - Submerged | Internal Hex | |||||||||||
| Non - Submerged | Internal Hex | - | Diameters | |||||||||
| (Ø) | 3.5, 3.86, 4.3, 4.6 | 3.5 | 4.5 | Diameters (Ø) | 4.27, 4.57, 4.7, 5.07, 5.2, 5.21, 5.5, 5.57, 5.7, 5.87, 6.0, 6.2, | |||||||
| 6.37, 6.5, 7.0 | 4.8, 6.0 | |||||||||||
| Endosseous | ||||||||||||
| Implant | Tapered, macro threads | Tapered, macro threads | Tapered, macro threads | Micro threaded, | ||||||||
| One Body Implant | Lengths(mm) | 4.55, 5.55, 6.55, 7.55, 8.55 | 8.3 | 5,7,9,12 | Lengths(mm) | 4.5, 5.5, 6.5, 7.5, 8.5 | ||||||
| 4.6, 5.6, 6.6, 7.6, 8.6 | 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10 | |||||||||||
| Range of | ||||||||||||
| Diameters | ||||||||||||
| (mm) | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5mm | 4.0, 4.5, 5, 5.5, 6, 6.5mm | NR Fix : 3.5 and 3.8 | |||||||||
| Magic FC : 4.0, 4.5, 5.0, 5.5, 6.0, | ||||||||||||
| 6.5mm | 3.0mm | Surface | ||||||||||
| Treatment | Machine- | Machine- | Machine- | Surface | ||||||||
| Treatment | Machine- | Machine- | ||||||||||
| Range of | ||||||||||||
| Lengths (mm) | 7, 8, 9, 10, 11, 12, 13mm | 7, 9, 11, 13mm | NR Fix 3.5 : 9, 11 13 | |||||||||
| NR Fix 3.8: 7, 10, 11, 12, 13, 14, | ||||||||||||
| 15mm | ||||||||||||
| Magic FC : 7, 9, 11, 13, 15mm | 10, 11.5, 13, 15mm | Sterilization | End User Sterilization | Steam sterilization by user | End User Sterilization | Sterilization | End User Sterilization | End User Sterilization | ||||
| Modified | ||||||||||||
| Surface | S.L.A | R.B.M | S.L.A | R.B.M | Principle of | |||||||
| Operation | Has one component to engage anti | |||||||||||
| rotational hex of implant body and the | ||||||||||||
| other component to fixate the abutment | ||||||||||||
| and implant body together. | Conventional procedure | Conventional procedure | Principle of Operation | Has one component to engage anti rotational hex of implant | ||||||||
| body and the other component to fixate the abutment and | ||||||||||||
| implant body together. | As general cement retained restoration, it is connected with | |||||||||||
| fixture and cemented crown on the abutment | ||||||||||||
| Surgical | ||||||||||||
| Technique | 1 stage and 2 stage, self tapping | 1 stage and 2 stage, self tapping | 1 stage and 2 stage, self tapping | 1 stage and 2 stage, self tapping | SE | |||||||
| Discussion | There is no similar product as the subject short abutment in the primary predicate, K152520. So, K171027 was added as reference device. | |||||||||||
| Both subject device and K171027 have similar indication for use and same functions, surface treatment, and general shape (design). The | ||||||||||||
| difference between subject and K171027 is material and dimensions. To support the discrepancy, K173575 was added and the difference | ||||||||||||
| doesn't affect device's fundamental functions and safety. | SE Discussion | There is no similar product as the subject magic abutment in the primary predicate, K152520. So, K160670 was added as | ||||||||||
| reference device. Both subject device and K160670 have similar indication for use and same functions, material, surface | ||||||||||||
| treatment, and general shape (design). The difference between subject and K160670 is dimensions. However, the difference | ||||||||||||
| doesn't affect device's fundamental functions and safety. | ||||||||||||
| Gamma | ||||||||||||
| Sterilization | Yes | Yes | Yes | Yes | ||||||||
| Principle | ||||||||||||
| Operation | Dental implant that can be | |||||||||||
| inserted on a jawbone as a | ||||||||||||
| material for dental surgery to | ||||||||||||
| support | Dental implant that can be | |||||||||||
| inserted on a jawbone as a | ||||||||||||
| material for dental surgery to | ||||||||||||
| support | Dental implant that can be inserted | |||||||||||
| on a jawbone as a material for | ||||||||||||
| dental surgery to support | Dental implant that can be inserted | |||||||||||
| on a jawbone as a material for | ||||||||||||
| dental surgery to support | ||||||||||||
| Similarities | The Magicore II System has same device characteristics with the Primary predicate devices, Magicore system (K152520) such as diameters, Length, | |||||||||||
| intended use, material, functions, general shape (Design), structure and applied production method are similar. | ||||||||||||
| Differences | The differences between the subject device and the primary predicate device is the dimension and surface treatment. Compared to the primary | |||||||||||
| predicate device, the subject device includes more variable length implants than the primary predicate device such as 8,10,12mm. But the range of | ||||||||||||
| the diameters are same from 7 to 13mm, which doesn't raise any questions about safety and effectiveness. K162099 was added as reference device to | ||||||||||||
| support the surface treatment of SLA for subject device. | ||||||||||||
| The differences between the subject device and predicate device (K080594) is range of Diameters and Lengths but it was added as reference device | ||||||||||||
| to support the subject device which has 4mm cuff height. |
6
7
2) Abutments
8
9
| Subject Device | Reference Device | ||
|---|---|---|---|
| Company | InnoBioSurg Co., Ltd. | Nobel Biocare AB | |
| Device Name | Magicore II System | Nobel Biocare Multi unit Abutment | |
| 510(k) Number | N/A | K072570 | |
| Indications for Use | The Magicore II System is intended to replace missing teeth to | ||
| restore chewing function. The Magicore II System can be | |||
| placed in support of single or 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. | NobelActive Multi Unit Abutment is a pre-manufactured | ||
| prosthetic component directly connected to the endosseous dental | |||
| implant and is intended for use as an aid in prosthetic | |||
| rehabilitation | |||
| Material | TI-6AL-4V ELI | --- | |
| Design | Image: Abutment | Image: Abutment | |
| (Abutment) Diameters | |||
| (Ø) | 4.8, 5.8 | 3.5, 4.3 | |
| Gingiva Height (mm) | 1.5, 2.5, 3.5, 4.5 | --- | |
| Angulation (°) | 15, 25° | 17, 30° | |
| Surface Treatment | Machine- | Machine- | |
| Sterilization | End User Sterilization | Gamma Sterilization | |
| Principle of Operation | Used in screw retained and cement retained restoration. | ||
| Magic Multi Abutment should be placed into patient's mouth | |||
| before taking impression. | Used in screw retained restoration only. | ||
| Multi unit Abutment should be placed into patient's mouth | |||
| before taking impression. | |||
| SE Discussion | There is no similar product as the subject magic multi abutment in the primary predicate, K152520. So, K072570 was added as | ||
| reference device. Both subject device and K072570 have similar indication for use and same functions, material, surface | |||
| treatment, and general shape (design). The difference between the subject and predicate devices are gingiva height and | |||
| angulations. The gingiva height of the subject device are shorter than the predicate device. The angulations are different between | |||
| subject and predicate devices; however, it doesn't affect device's fundamental functions since the angulation of the subject device | |||
| is smaller than the predicate's | |||
| Subject Device | Reference Device | ||
| Company | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | |
| Device Name | Magicore II System | IBS Implant System II | |
| 510(k) Number | N/A | K162099 | |
| Indications for Use | The Magicore II System is intended to replace missing teeth to | ||
| restore chewing function. The Magicore II System can be | |||
| placed in support of single or 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 IBS Implant System II is intended to replace missing teeth | ||
| to restore chewing function. The IBS Implant System II 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. | |||
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI | |
| Design | |||
| Diameters (Ø) | 5.0, 6.0 | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 | |
| Lengths(mm) | 10 | 12 | |
| Surface | |||
| Treatment | Machine- | Machine- | |
| Sterilization | End User Sterilization | End User Sterilization | |
| Cylinders are used in conjunction with screw retained type | |||
| Abutment to provide support for screw type final prosthesis, | |||
| Principle of Operation | |||
| and for fabrication of custom abutment for screw retained | |||
| restorations. | Cylinders are used in conjunction with screw retained type | ||
| Abutment to provide support for screw type final prosthesis, and | |||
| for fabrication of custom abutment for screw retained | |||
| restorations. | |||
| SE Discussion | There is no similar product as the subject magic multi Cylinder in the primary predicate, K152520. So, own | ||
| predicate was added as reference device. Both subject device and K162099 have similar indication for use and same functions, | |||
| material, surface treatment, and general shape (design). The difference between the subject and predicate device is the | |||
| device. However, it doesn't affect device's fundamental functions and safety. | |||
| Subject Device | Reference Device | ||
| Company | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | |
| Device Name | Magicore II System | IBS Implant System II | |
| 510(k) Number | N/A | K162099 | |
| Indications for Use | The Magicore II System is intended to replace missing teeth to | ||
| restore chewing function. The Magicore II System can be | |||
| placed in support of single or 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 IBS Implant System II is intended to replace missing teeth | ||
| to restore chewing function. The IBS Implant System II 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. | |||
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI | |
| Design | Image: Magicore II System Design | Image: IBS Implant System II Design | |
| Diameters (Ø) | 5.0, 6.0 | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 | |
| Lengths(mm) | 10 | 12 | |
| Surface | |||
| Treatment | Machine- | Machine- | |
| Sterilization | End User Sterilization | End User Sterilization | |
| Principle of Operation | The abutments are fixed to the underlying implant with an | ||
| abutment screw. | The abutments are fixed to the underlying implant with an | ||
| abutment screw. | |||
| SE Discussion | There is no similar product as the subject magic multi abutment ST in the primary predicate, K152520. So, K162099, our own | ||
| predicate was added as reference device. Both subject device and K162099 have similar indication for use and same functions, | |||
| material, surface treatment, and general shape (design). The difference between the subject and predicate device is the length of the | |||
| device. However, it doesn't affect device's fundamental functions and safety. |
10
11
12
| Subject Device | Reference Device | Reference Device | Subject Device | Reference Device | Subject Device | Reference Device | Reference Device | |||
|---|---|---|---|---|---|---|---|---|---|---|
| Company | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | DENTIS CO., LTD. | Company | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | Company | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | OSSTEM Implant Co., Ltd |
| Device Name | Magicore II System | IBS Implant System | Dentis Dental Implant System | Device Name | Magicore II System | IBS Implant System | Device Name | Magicore II System | CCM Abutment System | OSSTEM Implant System - |
| Abutment | ||||||||||
| 510(k) Number | N/A | K153350 | K150344 | 510(k) Number | N/A | K153350 | 510(k) Number | N/A | K173120 | K161689 |
| Indications for | ||||||||||
| Use | The Magicore II System is intended to | |||||||||
| replace missing teeth to restore chewing | ||||||||||
| function. The Magicore II System can be | ||||||||||
| placed in support of single or 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 IBS Implant System is intended to | |||||||||
| replace missing teeth to restore chewing | ||||||||||
| function. The IBS Implant can be placed in | ||||||||||
| support of single or multi-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 | ||||||||||
| surgical procedure. This system is intended | ||||||||||
| for delayed loading. | The Dentis Dental Implant System is an | |||||||||
| endosseous dental implant is indicated for | ||||||||||
| surgical placement in the upper and lower | ||||||||||
| jaw arches, to provide a root form means | ||||||||||
| for single or multiple-units prosthetic | ||||||||||
| appliance attachment to restore a patient's | ||||||||||
| chewing function. Implants can be placed | ||||||||||
| with a conventional two stage surgical | ||||||||||
| process with an option for transmucosal | ||||||||||
| healing or they can be placed in a single | ||||||||||
| stage surgical process for immediate | ||||||||||
| loading. Immediate loading is restricted to | ||||||||||
| the anterior | ||||||||||
| mandible based on four splinted | ||||||||||
| interforminal placed implants. | Indications for Use | The Magicore II System is intended to replace missing teeth to | ||||||||
| restore chewing function. The Magicore II System can be | ||||||||||
| placed in support of single or 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 IBS Implant System is intended to replace missing teeth to | |||||||||
| restore chewing function. The IBS Implant System can be | ||||||||||
| placed in support of single or multiple-unit restorations | ||||||||||
| including; cement retained, screw retained, or overdenture | ||||||||||
| restorations, and terminal or immediate abutment support for | ||||||||||
| fixed bridgework. This system is for one or two stage surgical | ||||||||||
| procedures and not for immediate loading. This system is | ||||||||||
| intended for delayed loading. | Indications for | |||||||||
| Use | The Magicore II System is intended to replace | |||||||||
| missing teeth to restore chewing function. The | ||||||||||
| Magicore II System can be placed in support of | ||||||||||
| single or 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 CCM Abutment System is intended to | |||||||||
| replace missing teeth to restore chewing | ||||||||||
| function. The CCM Abutment System can be | ||||||||||
| placed in support of single or multiple-unit | ||||||||||
| restorations including; cement retained, screw | ||||||||||
| retained, 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 OSSTEM Implant System |
- Abutment is intended for use with
a dental implant to provide support
for prosthetic restorations such as
crowns, bridges, or overdentures |
| Material | TI-6AL-4V ELI | Titanium Gr
4 | TI-6AL-4V ELI | Material | TI-6AL-4V ELI | TI-6AL-4V ELI | Material | TI-6AL-4V ELI | TI-6AL-4V ELI | Ti-6Al-4V |
| Design | Image: Design of Magicore II System | Image: Design of IBS Implant System | Image: Design of Dentis Dental Implant System | Design | Image: Magicore II System design | Image: IBS Implant System design | Design | Image: abutment | Image: abutment | Image: abutment |
| Diameters (Ø) | 5.2, 6.2 | 5.35 | 5.4 | Diameters (Ø) | 4.3 | 4, 4.5, 5 | Diameters (Ø) | 2.0 | 2.0 | 2.0, 2.05, 2.2, 2.3, 2.5 |
| Lengths(mm) | 4.5 | 4.95 | 5.0 | Lengths(mm) | 11.2, 12.2, 13.2, 14.2 | --- | Lengths(mm) | 5.2, 7.1 | 7 | 3.35, 5.6, 7.5, 8.35, 9.6, 10.2 |
| Surface
Treatment | Machine | Machine | Machine | Angulation (°) | 15°, 25° | 15°, 25°, 30° | Surface
Treatment | Machine | Machine | Machine |
| Sterilization | End user Sterilization | End user Sterilization | End user Sterilization | Surface
Treatment | Machine | Machine | Sterilization | End user Sterilization | End user Sterilization | End user Sterilization |
| Principle of
Operation | 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. | 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. | Conventional procedure | Sterilization | End User Sterilization | End User Sterilization | Principle of
Operation | Connection body to connect abutment to
fixture. | Connection body to connect abutment to
fixture. | Used to connect an abutment with
fixture. |
| SE Discussion | There is no similar product as the subject healing cap in the primary predicate, K152520. So, K153350, our own predicate was added as reference device. Both subject device and K153350 have same indication for use, functions, surface treatment, and general shape (design). The difference between subject and K153350 is material and dimensions. To support the discrepancy, K150344 was added and the difference doesn't affect device's fundamental functions and safety. | | | Principle of Operation | Used to fixate the abutment and implant body together. | Used to fixate the abutment and implant body together. | Similarities | The subject and Predicate device have same indications for use, functions, materials, surface treatment, general shape (design). | | |
| SE Discussion | There is no similar product as the subject magic multi abutment in the primary predicate, K152520. So, K153350, our own
predicate was added as reference device. Both subject device and K153350 have similar indication for use and same functions,
material, surface treatment, and general shape (design). The differences between the subject and predicate device are the design of
the device. However, it doesn't affect device's fundamental functions and safety. | | Differences | There is no similar product as the subject Abutment screw in the primary predicate, K152520. So, K173120, our own predicate was
added as reference device. Both subject device and K173120 have same indication for use, functions, material, surface treatment, and
general shape (design). The difference between subject and K173120 is lengths. To support the discrepancy, K161689 was added and the
difference doesn't affect device's fundamental functions and safety since the length of subject device is within the range of the reference
device's lengths. | | | | | | |
13
14
15
Non-Clinical Data:
Fatigue Testing according to ISO 14801:2016 was performed on the subject device under the worstcase scenario and its result is strong enough to achieve their intended use.
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
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 K152520.
- LAL information/testing per USP as referenced in K162099
- Shelf Life Test on Healing Abutments according to ASTM F1980 referenced in K152520 ●
- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-● 5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures referenced in K140806, K152520 and K162099
- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, and ISO 10993-10:2010 on abutments referenced in K152520 and K173120
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments". The surface treatment analysis was used to support the decision of substantial equivalence.
Conclusion
The Magicore II System 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, the Magicore II System and its predicates are substantially equivalent.