(30 days)
No
The document describes a dental implant system and its abutments, focusing on materials, dimensions, and intended use for replacing missing teeth. 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 addresses a medical condition and restores a bodily function.
No
The device is described as an implant system for replacing missing teeth, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states the abutments are fabricated from Ti-6AL-4V Eli and are provided non-sterile, indicating a physical hardware component.
Based on the provided information, 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 surgical and restorative procedure performed directly on the patient's body.
- Device Description: The device is described as "abutments" made from Ti-6AL-4V Eli, which are components of a dental implant system. These are physical implants and prosthetic components.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a physical implant and prosthetic component.
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
NHA
Device Description
This submission is to add new abutments to the previously cleared device. Magicore II System (K192197).
The newly added abutments are Magic Multiunit Abutments (Screw type – Hex. Non-Hex. Cemented type - Hex, Non-Hex) with the new angulations of 5, 10, 20°
For Magic Multiunit Cylinder, Magic Multiunit Abutment ST, and Mazic Multi Abutment Cap, no other changes are being made to the previous clearances except for model names.
The Abutments are fabricated from Ti-6AL-4V Eli (Conforming to ASTM Standard F-136).
The dimension ranges of the abutments are below:
Abutments Diameters (Ø) Lengths (mm) Angulation (°)
5 (Newly Added)
3.9- 7.5
10 (Newly Added)
Magic Multiunit Abutment 4.8 4.2-7.8 (Screw type - Hex, Non-Hex,
20 (Newly Added)
4.8-8.4
Cemented type – Hex, Non-Hex)
4-7.6
5 (Newly Added)
(Cleared in K192197)
5.8 4.3-7.9
10 (Newly Added)
20 (Newly Added)
4.9- 8.5
The subject abutments are compatible with implants in K192197.
The Abutments are provided non-sterile and packaged separately. The abutment should be sterilized before use.
The purpose of this submission is
- To add a new Magic Multiunit Abutment with angle 5, 10, 20°.
- To change the product name
| Product Name in K192197 | Product Name in Subject system |
|---|---|
| Magic Multi Abutment | Magic Multiunit Abutment |
| Magic Multi Cylinder | Magic Multiunit Cylinder |
| Magic Multi Abutment ST | Magic Multiunit Abutment ST |
| Healing Cap | Magic Multiunit Abutment Cap |
- To change the screw quantity 1ea to 2ea in a set package
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)
Non-Clinical Data
No need to perform any non-clinical testing for the subject device since and predicate device are substantially equivalent in indications, fundamental technology, material and design. Although the dimensions and angulations are different, by performing product's dimensional comparison analysis, it concluded that the predicate device is the mechanical worst case and demonstrated the substantial equivalence.
As both subject device and predicate device has same material and manufacturing process, it demonstrates the subject device is biocompatible and substantially equivalent.
The end user sterilization performed in predicate device can be leveraged for the subject device because both products have same material, manufacturing process, and sterility process and it demonstrated the substantial equivalence. The change of the screw quantity from 1 each to 2 each does not affect the sterility process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 15, 2020
InnoBioSurg Co., Ltd. % April Lee Consultant Withus Group Inc. 106 Superior Irvine, California 92620
Re: K201621
Trade/Device Name: Magicore II System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 13, 2020 Received: June 15, 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
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Indications for Use
510(k) Number (if known) K201621
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Submitter
InnoBioSurg Co., Ltd. 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
Device Information
- . K number: K201621
- . Trade Name: Magicore II System
- Common Name: Endosseous dental implant abutment .
- . Classification Name: Endosseous dental implant abutment
- . Product Code: NHA
- . Panel: Dental
- . Regulation Number: 872.3630
- . Device Class: Class II
- . Date prepared: 07/10/2020
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
K192197, Magicore II System manufactured by InnoBioSurg Co., Ltd.
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, 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.
Device Description
This submission is to add new abutments to the previously cleared device. Magicore II System (K192197).
The newly added abutments are Magic Multiunit Abutments (Screw type – Hex. Non-Hex. Cemented type - Hex, Non-Hex) with the new angulations of 5, 10, 20°
For Magic Multiunit Cylinder, Magic Multiunit Abutment ST, and Mazic Multi Abutment Cap, no other changes are being made to the previous clearances except for model names.
The Abutments are fabricated from Ti-6AL-4V Eli (Conforming to ASTM Standard F-136).
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
4
Abutments Diameters (Ø) Lengths (mm) Angulation (°) 5 (Newly Added) 3.9- 7.5 10 (Newly Added) Magic Multiunit Abutment 4.8 4.2-7.8 (Screw type - Hex, Non-Hex, 20 (Newly Added) 4.8-8.4 Cemented type – Hex, Non-Hex) 4-7.6 5 (Newly Added) (Cleared in K192197) 5.8 4.3-7.9 10 (Newly Added) 20 (Newly Added) 4.9- 8.5
The dimension ranges of the abutments are below:
The subject abutments are compatible with implants in K192197.
The Abutments are provided non-sterile and packaged separately. The abutment should be sterilized before use.
The purpose of this submission is
- . To add a new Magic Multiunit Abutment with angle 5, 10, 20°.
- . To change the product name
| Product Name in K192197 | Product Name in Subject system |
|---|---|
| Magic Multi Abutment | Magic Multiunit Abutment |
| Magic Multi Cylinder | Magic Multiunit Cylinder |
| Magic Multi Abutment ST | Magic Multiunit Abutment ST |
| Healing Cap | Magic Multiunit Abutment Cap |
- To change the screw quantity 1ea to 2ea in a set package ●
5
Summaries of Technology Characteristics:
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | Magicore II System | Magicore II System |
| Abutment Name | Magic Multiunit Abutment | Magic Multi Abutment |
| 510(k) No. | NA | K192197 |
| Instructions 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 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. | ||
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI |
| Design | Image: Abutment Design | Image: Abutment Design |
| Diameters (Ø) | 4.8, 5.8 | 4.8, 5.8 |
| Gingiva Height (mm) | 1.5, 2.5, 3.5, 4.5 | 1.5, 2.5, 3.5, 4.5 |
| Angulation (°) | 5, 10, 20° | 15, 25° |
| Surface Treatment | Machine- | Machine- |
| Sterilization | End User Sterilization | End User Sterilization |
Similarities
Magic Multiunit Abutments with 5, 10, 20° angulations have the same fundamental scientific technology, principle of operation, design, technology, functions, dimensions and materials.
Differences
- New Magic Multiunit Abutment: The Abutments with 5 °, 10 °, 20 ° angulation are added to the new subject system. Since the primary predicate's abutment is worst case (largest angulation), the difference doesn't impact product's safety and effectiveness and it demonstrates substantial equivalence.
6
Non-Clinical Data
No need to perform any non-clinical testing for the subject device since and predicate device are substantially equivalent in indications, fundamental technology, material and design. Although the dimensions and angulations are different, by performing product's dimensional comparison analysis, it concluded that the predicate device is the mechanical worst case and demonstrated the substantial equivalence.
As both subject device and predicate device has same material and manufacturing process, it demonstrates the subject device is biocompatible and substantially equivalent.
The end user sterilization performed in predicate device can be leveraged for the subject device because both products have same material, manufacturing process, and sterility process and it demonstrated the substantial equivalence. The change of the screw quantity from 1 each to 2 each does not affect the sterility process.
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.