(101 days)
The Magic UCLA Abutment System is intended to replace missing teeth to restore chewing function. The Magic UCLA 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 Magic UCLA Abutment System is used with a dental implant to provide support to prosthetic restorations such as crowns, bridges, and overdentures in partially or fully edentulous patients. The system includes Magic UCLA Screw Retained Type (Hex, Non-Hex) and Magic UCLA Cement Retained Type (Hex, Non-Hex) abutments. The abutments are fabricated from Co-Cr-Mo Alloy with Poly Diacetate, provided non-sterile, and packaged separately. They must be sterilized before use. The abutments are not intended to be cast at angulation or placed to provide angular correction.
The provided document is a 510(k) premarket notification for a dental device, the "Magic UCLA Abutment System." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for a new AI/medical image analysis device.
Therefore, this document does not contain the information required to answer your request about acceptance criteria and a study proving device performance for an AI/medical image analysis device.
The relevant sections of your request (acceptance criteria, test set details, expert ground truth, MRMC study, standalone performance, training set details) are specific to the validation of AI/image analysis algorithms, which is not the subject of this 510(k) submission. This submission is for a physical dental implant component and leverages non-clinical testing performed on predicate devices to demonstrate equivalence.
Here's a breakdown of why this document cannot fulfill your request:
- No AI/Image Analysis: The "Magic UCLA Abutment System" is a physical dental implant component (abutment). There is no mention of it being an AI device or involving image analysis.
- No Performance Study Against Acceptance Criteria (as you defined them): The document confirms "Non-clinical testing was not performed for the subject device" (page 9) because it's considered substantially equivalent to predicate devices based on material, manufacturing, and design similarities. The "tests" mentioned are biocompatibility, galvanic reaction, and sterilization tests, which are standard for physical medical devices and not related to AI performance metrics like sensitivity, specificity, F1-score, etc., nor do they involve human expert review for ground truth in the context of image analysis.
- No Test/Training Sets: Since there's no AI component, there are no test or training sets of data/images to evaluate an algorithm's performance.
- No Experts for Ground Truth (in the context of AI): The document doesn't discuss establishing ground truth by experts for image analysis.
- No MRMC Study: An MRMC study is relevant for evaluating human reader performance with and without AI assistance. This is not applicable here.
- No Standalone Performance: Standalone performance refers to an algorithm's performance without human intervention. This is not reported.
In summary, the provided text describes a regulatory submission for a physical dental device, not an AI or image analysis device, and thus does not contain the information requested about acceptance criteria and performance studies typical for AI/medical imaging products.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 3, 2020
InnoBioSurg Co., Ltd. % April Lee Consultant Withus Group Inc. 106 Superior Irvine, California 92620
Re: K202418
Trade/Device Name: Magic UCLA Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 3, 2020 Received: November 3, 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.
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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.
Andrew Steen Assistant 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) K202418
Device Name Magic UCLA Abutment System
Indications for Use (Describe)
The Magic UCLA Abutment System is intended to replace missing teeth to restore chewing function. The Magic UCLA 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Submitter
InnoBioSurg Co., Ltd. Sun-Mi Park 44-19, Techno 10-ro, Yuseong-gu Daejeon, 34027 Republic of Korea Email: sumpark@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: Magic UCLA Abutment System ●
- Common Name: Dental Abutment System
- Classification Name: Endosseous dental implant abutment
- Product Code: NHA
- Panel: Dental
- Regulation Number: 872.3630
- Device Class: Class II
- Date prepared: 12/02/2020
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
K173120, CCM Abutment System manufactured by InnoBioSurg Co., Ltd.
Reference Device
K153350, IBS Implant System manufactured by InnoBioSurg Co., Ltd.
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General Description
The purpose of this submission is to add abutments to the previously cleared device. CCM Abutment System (K173120). The added abutments are below:
Abutments
- . Magic UCLA Screw Retained Type (Hex, Non-Hex)
- Magic UCLA Cement Retained Type (Hex, Non-Hex) ●
The Magic UCLA Abutment System is used with a dental implant to provide support to prosthetic restorations such as crowns, bridges, and overdentures in partially or fully edentulous patients.
The subject device is compatible with the following implants:
| K Number | Compatible Implant |
|---|---|
| K152520 | Magicore System A L A P S M A P |
The dimension ranges of the abutments are below:
| Abutments | Diameter(mm) | Length (mm) |
|---|---|---|
| Magic UCLA Screw Retained Type | 4.5 | 10.2 |
| 5.2 | 10.4 | |
| 6.2 | 10.5 | |
| Magic UCLA Cement Retained Type | 4.5 | 10.5 |
| 5.2 | 11.1 | |
| 6.2 | 11.1 |
Tolerance of dimensions for Abutments shall be within ±1%.
The Magic UCLA Abutment System is provided non-sterile and packaged separately. The abutments should be sterilized before use. The Magic UCLA Screw Retained Type and the Magic UCLA Cement Retained Type are not intended to be cast at angulation or placed to provide angular correction.
Indications for Use
The Magic UCLA Abutment System is intended to replace missing teeth to restore chewing function. The Magic UCLA 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.
Materials
Abutments are fabricated from Co-Cr-Mo Alloy with Poly Diacetate.
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Image /page/5/Picture/0 description: The image shows the logo for IBS Implant. The logo is primarily blue and features a stylized "IBS" with a yellow star-like shape above the "I". Below the blue "IBS", the word "IMPLANT" is written in a smaller, sans-serif font.
InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu, Daejeon, 34027, Korea
Tel. 82-42-933-2879 / Fax. 82-42-933-2881
Summaries of Technological Characteristics:
| Magic UCLA Screw Retained Type (Hex, Non-Hex) | |||
|---|---|---|---|
| Device Name | Subject Device | Primary Predicate Device | Reference Predicate Device |
| Magic UCLA Abutment System | CCM Abutment System | IBS Implant system | |
| 510k | K202418 | K173120 | K153350 |
| Part Name | Magic UCLA Screw Retained Type | Burn out core cylinder | UCLA Abutment |
| Materials | Co-Cr-Mo AlloyPoly Diacetate | Co-Cr-Mo AlloyPoly Diacetate | Titanium AlloyPoly Diacetate |
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Indications for Use | The Magic UCLA Abutment System isintended to replace missing teeth torestore chewing function. The MagicUCLA Abutment System can be placedin support of single or multiple-unitrestorations including: cement retained,screw retained, and terminal orimmediate abutment support for fixedbridgework. This system is for one ortwo stage surgical procedures. Thissystem is intended for delayed loading. | The CCM Abutment System is intendedto replace missing teeth to restorechewing function. The CCM AbutmentSystem can be placed in support ofsingle or multiple-unit restorationsincluding: cement retained, screwretained, and terminal or immediateabutment support for fixed bridgework.This system is for one or two stagesurgical procedures. This system isintended for delayed loading. | The IBS Implant System is intended toreplace missing teeth to restore chewingfunction. The IBS Implant can be placed insupport of single or multiple-unitrestorations including: cement retained,screw retained, or overdenture restorations,and terminal or immediate abutment supportfor fixed bridgework. This system is for oneor two stage surgical procedures. Thissystem is intended for delayed loading. |
| Principle of Operation | A screw retained restoration type ofabutment using a screw to fix aprosthesis. | A screw retained restoration type ofabutment using a screw to fix aprosthesis. | A screw retained restoration type ofabutment using a screw to fix a prosthesis. |
| Hex | |||
| Dimensions | 4.5, 5.2, 6.2mm (Ø) X 10.2, 10.4,10.5mm (L) | 5, 6mm (Ø) X 8.5, 8.65mm (L) | 3.5, 4, 4.5, 5, 5.5mm (Ø) X 14, 15,16, 17mm (L) |
| Restoration angulations | No Angle | No Angle | No Angle |
| Design | |||
| Non-Hex | |||
| Dimensions | 4.5, 5.2, 6.2mm (Ø) X 10.2, 10.4,10.5mm (L) | 5, 6mm (Ø) X 8.5, 8.65mm (L) | 3.5, 4, 4.5, 5, 5.5mm (Ø) X 14, 15,16, 17mm (L) |
| Restoration angulations | No Angle | No Angle | No Angle |
| Design |
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Image /page/6/Picture/0 description: The image shows the logo for IBS Implant. The logo consists of the letters "IBS" in a stylized, blocky font, with a small yellow star above the "I". Below the letters, the word "IMPLANT" is written in a smaller, sans-serif font. The letters "IBS" are in blue.
InnoBioSurg Co., Lt
44-19, Techno 10-ro, Yuseong-gu, Daejeon, 34027, Korea Tel. 82- 42-933-2879 / Fax. 82-42-933-2881
Similarities
The Magic UCLA Screw Retained Type is substantially equivalent in indications for use, fundamental scientific technology, principle of operation, functions, and materials as the identified predicates.
Differences
Compared to the primary predicate device, new abutments with various dimensions are added to the subject system. To support the dimension differences between the primary predicate device, K153350 was added as the reference device. The dimensions of the subject device are in range of the ceference device and the slight difference does not affect the application and fundamental scientific technology of the device. Therefore, it is concluded that the Magic UCLA Screw Retained Type is substantially equivalent with the predicate devices.
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Image /page/7/Picture/0 description: The image shows a logo for a company called "IBS Implant". The logo consists of the letters "IBS" stacked on top of each other in a stylized font, with the word "IMPLANT" written below. The letters "IBS" are dark blue, and there is a yellow star-like shape above the "I". The word "IMPLANT" is also 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
| Magic UCLA Cement Retained Type (Hex, Non-Hex) | |||
|---|---|---|---|
| Subject Device | Primary Predicate Device | Reference Predicate Device | |
| Device Name | Magic UCLA Abutment System | CCM Abutment System | IBS Implant system |
| 510k | K202418 | K173120 | K153350 |
| Part Name | Magic UCLA Cement Retained Type | Burn out core cap | UCLA Abutment |
| Materials | Co-Cr-Mo AlloyPoly Diacetate | Co-Cr-Mo AlloyPoly Diacetate | Titanium AlloyPoly Diacetate |
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Indications for Use | The Magic UCLA Abutment System isintended to replace missing teeth torestore chewing function. The MagicUCLA Abutment System can be placedin support of single or multiple-unitrestorations including: cement retained,screw retained, and terminal orimmediate abutment support for fixedbridgework. This system is for one ortwo stage surgical procedures. Thissystem is intended for delayed loading. | The CCM Abutment System is intendedto replace missing teeth to restorechewing function. The CCM AbutmentSystem can be placed in support ofsingle or multiple-unit restorationsincluding: cement retained, screwretained, and terminal or immediateabutment support for fixed bridgework.This system is for one or two stagesurgical procedures. This system isintended for delayed loading. | The IBS Implant System is intended toreplace missing teeth to restore chewingfunction. The IBS Implant can be placed insupport of single or multiple-unitrestorations including: cement retained,screw retained, or overdenture restorations,and terminal or immediate abutment supporfor fixed bridgework. This system is for oneor two stage surgical procedures. Thissystem is intended for delayed loading. |
| Principle of Operation | A screw retained restoration typeof abutment using a screw to fix aprosthesis. | A screw retained restoration typeof abutment using a screw to fix aprosthesis. | A screw retained restoration type ofabutment using a screw to fix a prosthesis. |
| Hex | |||
| Dimensions | 4.5, 5.2, 6.2mm (Ø) X 10.5,11.1mm (L) | 5, 6mm (Ø) X 9.15mm (L) | 3.5, 4,4.5,5, 5.5mm (Ø) X 14, 15,16, 17mm (L) |
| Restoration angulations | No Angle | No Angle | No Angle |
| Design | |||
| Image: dental implant | Image: dental implant | Image: dental implants | |
| Non-Hex | |||
| Dimensions | 4.5, 5.2, 6.2mm (Ø) X 10.5,11.1mm (L) | 5, 6mm (Ø) X 9.15 mm (L) | 3.5,4,4.5, 5, 5.5mm (Ø) X 14, 15,16, 17mm (L) |
| Restoration angulations | No Angle | No Angle | No Angle |
| Design | |||
| Image: dental implant | Image: dental implant | Image: dental implants |
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Image /page/8/Picture/0 description: The image shows a logo for IBS Implant. The logo is composed of the letters "IBS" stacked on top of each other in a stylized, sans-serif 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 Magic UCLA Cement Retained Type is substantially equivalent in indications for use, fundamental scientific technology, principle of operation, functions, and materials as the identified predicates.
Differences
Compared to the primary predicate device, new abutments with various dimensions are added to the subject system. To support the dimension differences between the primary predicate device. K153350 was added as the reference device. The dimensions of the subject device are in range of the reference device and the slight difference does not affect the application and fundamental scientific technology of the device, it is concluded that the Magic UCLA Cement Retained Type is substantially equivalent with the predicate devices.
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Image /page/9/Picture/0 description: The image shows the logo for IBS Implant. The logo is primarily blue and features the letters "IBS" stacked on top of each other. The "I" has a yellow star-like shape in the upper left corner. Below the letters, the word "IMPLANT" is written in a smaller, sans-serif font.
Non-Clinical Data
Non-clinical testing was not performed for the subject device because the subject device and predicate devices are substantially equivalent in indications, fundamental scientific technology, materials, and design. By performing the product's design controls activity summary, it is concluded that any differences do not impact the product's safety and effectiveness and demonstrate substantial equivalence.
The tests below were performed for the predicate devices and leveraged for the subject device:
- Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, . ISO 10993-10:2010, and ISO 10993-11:2006 referenced in K173120
- Galvanic Reaction Test between CoCr alloy and non-precious metals referenced in K173120 ●
- End User Steam Sterilization Test according to ISO 17665-1:2006, -2:2009, and ● ANSI/AAMI ST79 referenced in K192197
The results of the above tests have met the criteria of the standards, and demonstrated substantial equivalence with the predicate devices.
The Biocompatibility Test was conducted on the primary predicate and leveraged for the subject device because both products are manufactured with the same materials and undergo the same manufacturing process. It demonstrates that the subject device is biocompatible and substantially equivalent with the predicate.
The galvanic reaction testing between the CoCr alloy and non-precious dental alloys, Ti Grade 5, was performed on the primary predicate and compatible implants. Per FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", corrosion potential of each CoCr and Ti Grade 5 alloy and couple potential for assembled CoCr and Ti Grade 5 alloy were assessed.
The end user sterilization test was performed for the predicate device. K192197, and leveraged for the subject device because the product category, materials, manufacturing process, facility, and packaging is the exactly the same as the predicate, K192197.
Mechanical testing such as fatigue testing was not performed for the subject device because per FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", the Magic UCLA Abutment System is not intended to be cast at angulation or placed to provide angular correction.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate devices.
Conclusions
The Magic UCLA Abutment 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 the predicate devices. Therefore, the Magic UCLA Abutment System is substantially equivalent.
§ 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.)