(42 days)
No
The summary describes a dental implant system made of standard materials and manufacturing processes, with no mention of AI/ML 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
The device is a dental implant system intended to replace missing teeth and restore chewing function, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states it consists of physical components like dental implants and screws made of Ti-6AL-4V Eli, which are hardware.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "replace missing teeth to restore chewing function." This is a direct therapeutic intervention within the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The device is described as "endosseous dental implants" and related components (abutments, screws, healing caps). These are physical devices implanted into bone.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly a medical device intended for surgical implantation to restore dental function.
N/A
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 (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
This submission is to add new implants and abutments to the previously cleared device, Magicore System (K152520).
The newly added implants and abutments are below:
Fixture
- Magicore (4mm of Neck length Implants) .
- . Magicore (Cutting Edge)
Abutment
- Magicore Solid Abutment
- Healing Cap
For Magicore Solid Abutment Cap, no other changes are being made to the previous clearance except for product name change.
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, 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 dimension ranges of the fixtures are below:
Fixture
Magicore (Cleared in K152520)
Diameters (Ø): 4, 4.5, 5, 5.5, 6, 6.5
Neck Lengths (mm): 1, 2, 3, 4 (Newly Added)
Length (mm): 7, 8, 9, 10, 11, 12, 13
Magicore (Cutting Edge) (Newly Added)
Diameters (Ø): 4, 4.5, 5, 5.5, 6, 6.5
Neck Lengths (mm): 1,2,3,4
Length (mm): 7, 8, 9, 10, 11, 12, 13
Abutments
Magicore Solid Abutment (Cleared in K152520)
Diameters (Ø): 3.5, 3.86, 4.3, 4.6
Length of Cuff (mm): 7.6 (Newly Added), 8.6 (Newly Added), 9.6, 10.6, 11.6
Magicore Solid Abutment Cap (Cleared in K152520)
Diameters (Ø): 5.5, 6.0, 6.5, 7.0
Length of Cuff (mm): 5.5, 6.5, 7.5, 8.5, 9.5
Healing Cap (Cleared in K152520)
Diameters (Ø): 5.3 (Newly Added), 5.5, 6.0, 6.3 (Newly Added), 6.5, 6.9, 7.6
Cuff (mm): 2.8, 5.3 (Newly Added), 4.2
Tolerance of dimension for Fixtures and Abutments shall be within ±1% range.
Fixtures and abutments are packaged separately. The Fixtures are supplied sterile. Fixtures are packaged with closing screw.
The Healing cap, Magicore Solid Abutment and Magicore Solid Abutment Caps are provided non-sterile and packaged together. The Healing Cap, Magicore Solid Abutments and Magicore Solid Abutment Caps should be sterilized before use.
The purpose of this submission is
- To add new Magicore Fixtures with neck length 4mm.
- . To change the product code of the previously cleared Magicore Fixtures by changing "C" to "B" at the end of the product code.
- To add new Magicore Fixtures (Cutting Edge). ●
- To add new Healing Caps, 5.3, 6.3mm diameters with 2.8, 5.3mm cuff lengths.
- To add new Magicore Solid Abutments, 3.5, 3.86, 4.3, 4.6mm diameters with 7.6, 8.6mm lengths
- To change the product name as below:
Product Name in K192197 | New Product Name in Subject system
Magicore Abutment | Magicore Solid Abutment
Magicore Abutment Cap | Magicore Solid Abutment Cap
Materials:
Fixtures and Abutments are fabricated from Ti-6AL-4V Eli (Conforming to ASTM Standard F-136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Missing teeth (oral cavity)
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 for the subject device was performed. The predicate and reference devices were leveraged for the subject device.
Tests performed for predicate devices and leveraged for the subject device:
- Sterilization validation according to ISO 11137-1 and ISO 11137-2 on Fixtures referenced in K140806
- Bacterial endotoxin Testing according to USP on Fixtures as referenced in K162099
- Shelf Life Test according to ASTM F1980 on fixtures 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 and K152520
- 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
- End User Sterilization Validation testing according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2. ISO 11737-1. ISO 11737-2, and ISO 11138-1 on Abutments 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 conducted as the subject device does not contain any angulated abutments.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K140806, K162099, K192197, K181138, K171027
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 27, 2020
InnoBioSurg Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K201981
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: August 14, 2020 Received: August 19, 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.
Srinivas Nandkumar, Ph.D. for 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) K201981
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
Submitter
InnoBioSurg Co., Ltd. Bo-Yeon Lim 44-19, Techno 10-ro, Yuseong-gu Daejeon, 34027 Republic of Korea Email: bylim@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 abutment
- Classification Name: Endosseous dental implant abutment
- . Primary Product Code: DZE
- Secondary Product Code: NHA
- . Panel: Dental
- Regulation Number: 872.3640
- . Device Class: Class II
- Date prepared: 08/26/2020
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
K140806, IBS Implant System by InnoBioSurg Co., Ltd.
K162099, IBS Implant System II by InnoBioSurg Co., Ltd.
K192197, Magicore II System manufactured by InnoBioSurg Co., Ltd.
K181138, IS-III active System manufactured by Neobiotech Co., Ltd.
K171027, Dentis Dental Implant System manufactured by Dentis Co., Ltd.
4
General Description
This submission is to add new implants and abutments to the previously cleared device, Magicore System (K152520).
The newly added implants and abutments are below:
Fixture
- Magicore (4mm of Neck length Implants) .
- . Magicore (Cutting Edge)
Abutment
- Magicore Solid Abutment
- Healing Cap
For Magicore Solid Abutment Cap, no other changes are being made to the previous clearance except for product name change.
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, 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 dimension ranges of the fixtures are below:
| Fixture | Diameters (Ø) | Neck Lengths (mm) | Length (mm) |
|---|---|---|---|
| Magicore | |||
| (Cleared in K152520) | 4 | 1, 2, 3 | |
| 4 (Newly Added) | 7, 8, 9, 10, 11, 12, 13 | ||
| 4.5 | 1, 2, 3 | ||
| 4 (Newly Added) | 7, 8, 9, 10, 11, 12, 13 | ||
| 5 | 1, 2, 3 | ||
| 4 (Newly Added) | 7, 8, 9, 10, 11, 12, 13 | ||
| 5.5 | 1, 2, 3 | ||
| 4 (Newly Added) | 7, 8, 9, 10, 11, 12, 13 | ||
| 6 | 1, 2, 3 | ||
| 4 (Newly Added) | 7, 8, 9, 10, 11, 12, 13 | ||
| 6.5 | 1, 2, 3 | ||
| 4 (Newly Added) | 7, 8, 9, 10, 11, 12, 13 | ||
| Fixture | Diameters (Ø) | Neck Lengths (mm) | Length (mm) |
| Magicore (Cutting Edge) | |||
| (Newly Added) | 4 | 1,2,3,4 | 7, 8, 9, 10, 11, 12, 13 |
| 4.5 | 1,2,3,4 | 7, 8, 9, 10, 11, 12, 13 | |
| 5 | 1,2,3,4 | 7, 8, 9, 10, 11, 12, 13 | |
| 5.5 | 1,2,3,4 | 7, 8, 9, 10, 11, 12, 13 | |
| 6 | 1,2,3,4 | 7, 8, 9, 10, 11, 12, 13 | |
| 6.5 | 1,2,3,4 | 7, 8, 9, 10, 11, 12, 13 |
5
| Abutments | Diameters (Ø) | Length of Cuff (mm) |
|---|---|---|
| Magicore Solid Abutment | ||
| (Cleared in K152520) | 3.5, 3.86, 4.3, 4.6 | 7.6 (Newly Added) |
| 8.6 (Newly Added) | ||
| 9.6, 10.6, 11.6 | ||
| Magicore Solid Abutment Cap | ||
| (Cleared in K152520) | 5.5, 6.0, 6.5, 7.0 | 5.5, 6.5, 7.5, 8.5, 9.5 |
| Healing Cap | ||
| (Cleared in K152520) | 5.3 (Newly Added) | Cuff: 2.8, 5.3 (Newly Added) |
| 5.5, 6.0 | Cuff: 4.2 | |
| 6.3 (Newly Added) | Cuff: 2.8, 5.3 (Newly Added) | |
| 6.5, 6.9, 7.6 | Cuff: 4.2 |
Below is abutments dimension range:
Tolerance of dimension for Fixtures and Abutments shall be within ±1% range.
Fixtures and abutments are packaged separately. The Fixtures are supplied sterile. Fixtures are packaged with closing screw.
The Healing cap, Magicore Solid Abutment and Magicore Solid Abutment Caps are provided non-sterile and packaged together. The Healing Cap, Magicore Solid Abutments and Magicore Solid Abutment Caps should be sterilized before use.
The purpose of this submission is
- To add new Magicore Fixtures with neck length 4mm.
- . To change the product code of the previously cleared Magicore Fixtures by changing "C" to "B" at the end of the product code.
- To add new Magicore Fixtures (Cutting Edge). ●
- To add new Healing Caps, 5.3, 6.3mm diameters with 2.8, 5.3mm cuff lengths.
- To add new Magicore Solid Abutments, 3.5, 3.86, 4.3, 4.6mm diameters with 7.6, 8.6mm lengths
- To change the product name as below:
| Product Name in K192197 | New Product Name in Subject system |
|---|---|
| Magicore Abutment | Magicore Solid Abutment |
| Magicore Abutment Cap | Magicore Solid Abutment Cap |
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. This system is intended for delayed loading.
Materials:
Fixtures and Abutments are fabricated from Ti-6AL-4V Eli (Conforming to ASTM Standard F-136).
6
Image /page/6/Picture/0 description: The image contains a logo for a company called "IDS Implant". The logo is composed of the letters "IDS" stacked on top of each other in a stylized, sans-serif font. The letters are dark blue, and there is a small yellow star-like shape in the upper left corner of the "I". Below the letters, the word "IMPLANT" is written in a smaller, sans-serif font, also in dark blue.
InnoBioSurrg Co., Ltd.
44-19, Techno 10-ro, Yuseong-gu, Daejeon, 34027, Korea
1 - Tel. 82- 42-933-2879 Fax. 82-42-933-2881
Tel. 82-42-933-2879 / Fax. 82-42-933-2881
Summaries of Technology Characteristics:
1) Fixture
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd |
| Device Name | Magicore System | Magicore System | Magicore II System |
| 510(k) No. | N/A | K152520 | K192197 |
| 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 | 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 | 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. | support for fixed bridgework. This | ||
| system is for one or two stage | |||
| surgical procedures. This system is | |||
| intended for delayed loading. | support for fixed bridgework. This | ||
| system is for one or two stage | |||
| surgical procedures. This system is | |||
| intended for delayed loading. | |||
| Design | Image: dental implant | Image: dental implant | Image: dental implant |
| Cutting Edge, Non-Cutting Edge | Non-Cutting Edge | Cutting Edge, Non-Cutting Edge | |
| Composition of | Titanium Alloy | ||
| Ti-6Al-4V Eli | Titanium Alloy | ||
| Ti-6Al-4V Eli | Titanium Alloy | ||
| Ti-6Al-4V Eli | |||
| Material | ASTM F136 | ASTM F136 | ASTM F136 |
| Connection | Internal Hex | ||
| Non - Submerged | Internal Hex | ||
| Non - Submerged | Internal Hex | ||
| Non - Submerged | |||
| Endosseous Implant | Tapered, macro threads | Tapered, macro threads | Tapered, macro threads |
| Range of Diameters | |||
| (mm) | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5mm | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5mm | 4.0, 4.5, 5.0, 5.5, 6, 6.5mm |
| Neck Length (mm) | 1, 2, 3, 4mm | 1, 2, 3, 4mm | 1, 2, 3, 4mm |
| Range of Lengths | |||
| (mm) | 7, 8, 9, 10, 11, 12, 13mm | 7, 8, 9, 10, 11, 12, 13mm | 7, 8, 9, 10, 11, 12, 13mm |
| Modified Surface | R.B.M | R.B.M | S.L.A |
| 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 |
7
Image /page/7/Picture/0 description: The image shows the logo for IBS Implant. The logo consists of the letters "IBS" stacked on top of each other in a stylized, geometric font. The letters are dark blue, and there is a yellow star-like shape in the upper left corner of the "I". Below the letters, the word "IMPLANT" is written in a smaller, sans-serif font, also in dark blue.
InnoBioSurg Co., Ltd.
44-19, Techno 10-ro, Yuseong-gu, Daejeon, 34027, Korea Tel. 82- 42-933-2879 / Fax. 82-42-933-2881
Similarities
The Magicore System has same device characteristics with the Primary predicate and Reference devices such as diameters, Length, intended use, material, functions, general shape (Design), structure and applied production method.
Differences
New Magicore Fixture with 4mm neck length: Compary predicate, the subject's device's neck length is longer, he neck length of subject device is included in range of reference predicate neck length, Magicore II System. Therefore, it doesn't impact product's substantial equivalence.
8
Image /page/8/Picture/0 description: The image contains a logo for IMPLANT. The logo is blue and white, with a stylized "IBS" in a bold, sans-serif font. A yellow star is located in the upper left corner of the "I". The word "IMPLANT" is written in a smaller, sans-serif font below the "IBS".
2) Abutments
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd | Neobiotech Co., Ltd. |
| Device Name | Magicore System | Magicore System | IS-III active System |
| 510(k) No. | N/A | K152520 | K181138 |
| Composition of | |||
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Design | Image: Subject Device Design | Image: Primary Predicate Design | Image: Reference Device Design |
| Range of | |||
| Diameters (mm) | 5.3, 5.5, 6.0, 6.3, 6.5, 6.9, 7.6mm | 5.5, 6.0, 6.5, 6.9, 7.6mm | 4.0, 4.5, 4.8, 5.5, 6.0, 6.8, 8.0, 9.0mm |
| Cuff (mm) | 2.8, 4.2, 5.3mm | 4.2mm | 2.3, 2.8, 3.3, 3.8, 4.3, 4.8, 5.3, 5.8, |
| 6.3, 6.8, 7.8mm | |||
| Surface | |||
| treatment | Anodizing | ||
| (Green, Purple, Blue, Yellow) | Anodizing | ||
| (Green, Purple, Blue, Yellow) | Machine | ||
| Gamma | |||
| Sterilization | No | No | Yes |
Similarities
The Healing Cap has substantially equivalent in intended use, fundamental scientific technology, principle of operation, design, functions, surface treatment and materials as the identified predicates.
Differences
Dimensions: Compared to the Primary predicate device 5.3, 6.3mm diameter with 2.8mm 5.3mm cuff lengths are added to the new subject system. The smaller diameters and shorter cuffs of the subject device allows space when healing gingiva. To support the dimensional differences, we selected K181138 as the reference device's dimensional range. Therefore, the difference doesn't affect product's fundamental functions.
9
Image /page/9/Picture/0 description: The image contains a logo for a company called "IBS IMPLANT". The logo features the letters "IBS" stacked on top of each other in a stylized, blue font. A yellow star is placed to the left of the "I" in "IBS". Below the letters, the word "IMPLANT" is written in a smaller, blue font.
InnoBioSurg Co., Ltd.
44-19, Techno 10-ro, Yuseong-gu, Daejeon, 34027, Korea Tel. 82- 42-933-2879 / Fax. 82-42-933-2881
| Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd |
| Device Name | Magicore System | Magicore System | Magicore System II |
| Model Name | Magicore Solid Abutment | Magicore Abutment | Short Abutment |
| 510(k) No. | N/A | K152520 | K192197 |
| Composition of | |||
| 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 Predicate |
| Range of | |||
| Diameters (mm) | 3.5, 3.86, 4.3, 4.6mm | 3.5, 3.86, 4.3, 4.6mm | 3.5, 3.86, 4.3, 4.6mm |
| Range of Height | |||
| (mm) | 2, 3, 4, 5, 6mm | 4, 5, 6mm | 2, 3, 4, 5, 6mm |
| Surface Treatment | N/A | N/A | N/A |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
Similarities
The Magicore Solid Abutment has a substantially equivalent intended use as the identified predicates. The subject device is same in fundamental scientific technology, manufacture, principle of operation, general shape (design), functions diameter and material.
Differences
New Magicore Solid Abutment: Compared to the dimension of Primary predicate and Subject device is same. The difference between the subject device and predicate device (K192197) is integral with screw. The difference doesn't affect product's functions.
10
Image /page/10/Picture/0 description: The image shows the logo for IBS Implant. The logo consists of the letters "IBS" stacked on top of each other in blue, with a yellow star above the "I". Below the letters is the word "IMPLANT" in a smaller font size. The logo is simple and modern, and the use of blue and yellow gives it a professional look.
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd |
| Device Name | Magicore System | Magicore System |
| Model Name | Magicore Solid Abutment Cap | Magicore Abutment Cap |
| 510(k) No. | N/A | K152520 |
| Design | Image: Abutment Cap Design | Image: Abutment Cap Design |
| Composition of Material | Poly Oxy Methylene (POM) | Poly Oxy Methylene (POM) |
| Range of Diameters | ||
| (mm) | 5.5, 6.0, 6.5, 7.0mm | 5.5, 6.0, 6.5, 7.0mm |
| Range of Lengths (mm) | 5.5, 6.5, 7.5, 8.5, 9.5mm | 5.5, 6.5, 7.5, 8.5, 9.5mm |
| Sterilization | End Use Sterilization | End Use Sterilization |
Similarities
The Magicore Solid Abutment Cap has same fundamental scientific technology, principle of operation, general shape (design), functions, diameter and material to the predicate.
Differences
Only change the product name. Therefore, it doesn't impact product's substantial equivalence.
11
Image /page/11/Picture/0 description: The image shows the logo for Implant Direct Services (IDS). The logo features the letters "IDS" in a stylized, bold, dark blue font. A yellow star is positioned above the "I". Below the letters, the word "IMPLANT" is written in a smaller, sans-serif font, also in dark blue.
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 and design. The predicate and reference devices may be leveraged for the subject devices because of using the same materials, manufacturing methods, and sterilization procedures. Although the dimensions are slightly different, it doesn't impact the ability to determine substantial equivalence of the subject devices because the predicate and reference 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 according to ISO 11137-1 and ISO 11137-2 on Fixtures referenced in K140806
- Bacterial endotoxin Testing according to USP on Fixtures as referenced in K162099 ●
- Shelf Life Test according to ASTM F1980 on fixtures 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 and K152520
- 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
- End User Sterilization Validation testing according to ANSI/AAMI ST79, ISO 17665-1, ISO ● 17665-2. ISO 11737-1. ISO 11737-2, and ISO 11138-1 on Abutments 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 conducted as the subject device does not contain any angulated abutments.
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.