(300 days)
The IBS System is intended to replace missing teeth to restore chewing function. The IBS 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 fixtures and abutments in this system are below:
- Fixture
- Magicore (RBM)
- Magicore (RBM Cutting Edge)
- Magicore II (SLA) .
- Magicore II (SLA Cutting Edge)
- Abutment
- Magic Angled Abutment (Screw type _Hex, Non-Hex) ●
- Magic Motion
- Magic Motion Housing ●
- Magic Abutment (Screw type Hex, Non-Hex & Cement type Hex, Non-Hex) ●
- Magic Multiunit Abutment (Cement type Hex, Non-Hex)
- Magic Multiunit Cap .
An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The implant-abutment connection is tight and precise fitting with internal hex, non-hex and Morse taper bevel. The surface of the Magicore implant is treated with RBM (Resorbable Blasted media) and Magicore II implants are treated with SLA(sand-blasted, large-grit, acid-etched).
The provided text is a 510(k) summary for the IBS System, an endosseous dental implant. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance data against acceptance criteria from a study on the IBS System itself. Therefore, I cannot extract the full details you requested regarding acceptance criteria and the study that proves the device meets them.
The document primarily shows a comparison of technological characteristics between the subject device (IBS System) and various predicate and reference devices. The "SE Discussion" (Substantial Equivalence Discussion) sections explain why the differences are not considered to affect safety and effectiveness, thus supporting the claim of substantial equivalence.
However, I can extract the following information based on the provided text, particularly from the "Non-Clinical Data" section, which outlines the types of tests performed and the standards met:
Inferred Acceptance Criteria and Reported Device Performance (Summary based on tests performed for substantial equivalence):
| Acceptance Criteria Category | Reported Device Performance (Based on testing standards met) |
|---|---|
| Sterilization (Abutments) | Met standards: ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1. Sterility Assurance Level (SAL) of 10-6 achieved via overkill method (Moist heat). |
| Biocompatibility (Abutments) | Met standards: ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, and ISO 10993-10:2010. Demonstrated that subject abutments are biocompatible. |
| Surface Modification | Surface roughness, surface composition analysis, and SEM imaging provided to demonstrate substantial equivalence to predicate devices K152520 and K162099 for RBM and SLA treatments. (The document states "this surface change is intended to only improve scanning surface area and does not affect the actual equivalence of the product.") |
| Packaging (Aseptic Presentation) | Human Factors testing (usability evaluation in line with ISO 11607-1:2019 and FDA guidance), evaluation of broken tip at various degrees of rotation, and Quality System (QS) plan to ensure conformance with product specifications. |
| Materials | Verified to be Ti-6AL-4V ELI (conforming to ASTM Standard F-136) for fixtures and most abutments, and Co-Cr-Mo Alloy for the body of the Magic Motion abutment. |
Further Breakdown of Requested Information (where available):
-
A table of acceptance criteria and the reported device performance: See table above. It's important to note that these are inferred from the standards cited as being met for establishing substantial equivalence, not explicit performance metrics from a comparative study of the new device against specific performance criteria.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text for any of the non-clinical tests (e.g., number of abutments for sterilization, number of implants for fatigue testing, number of participants for human factors).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The manufacturer is InnoBioSurg Co., Ltd. from the Republic of Korea.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. This document describes non-clinical engineering and biological tests, not studies involving human expert assessment for ground truth.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. As above, this is for non-clinical testing.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an endosseous dental implant, not an AI-powered diagnostic or assistive technology.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Sterilization: Ground truth is defined by the demonstrated sterility assurance level (SAL) of 10^-6, verified by biological indicators and physical parameters outlined in the referenced ISO and AAMI standards.
- For Biocompatibility: Ground truth is established by the cellular responses and tissue reactions observed in tests, interpreted against the criteria of the ISO 10993 series.
- For Fatigue Testing: Ground truth is the material's resistance to fracture under cyclic loading, compared to the ISO 14801:2016 standard.
- For Surface Modification: Ground truth involves microscopic and chemical analysis (e.g., surface roughness, composition analysis, SEM imaging) against established benchmarks or predicate device characteristics.
-
The sample size for the training set: Not applicable. This is not a machine learning or AI device.
-
How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
InnoBioSurg Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
12/20/22
Re: K220517
Trade/Device Name: IBS System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 21, 2022 Received: November 21, 2022
Dear April Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220517
Device Name IBS System
Indications for Use (Describe)
The IBS System is intended to replace missing teeth to restore chewing function. The IBS System can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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{3}------------------------------------------------
510(K) Summary
Submitter
InnoBioSurg Co., Ltd. Ga Yun Kim 44-19. Techno 10-ro. Yuseong-gu Daejeon, 34027 Republic of Korea Email: gykim1@ibsimplant.com Tel. +82-42-933-2879 Fax. +82-42-933-2881
Device Information
- Trade Name: IBS System .
- . Common Name: Endosseous Dental Implant
- Classification Name: Implant, Endosseous, Root-Form .
- Product Code: DZE
- . Secondary Product Code: NHA
- . Panel: Dental
- . Regulation Number: 872.3640
- . Date prepared: 12/20/2022
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate K212517, Magicore System by InnoBioSurg Co., Ltd.
Reference Device
K152520, Magicore System by InnoBioSurg Co., Ltd. K173120, CCM Abutment System by InnoBioSurg Co., Ltd. K181138, CMI Implant IS System by Neobiotech Co. Ltd. K182448, AnyRidge Octa 1 Implant System by MegaGen Implant Co. Ltd. K192197, Magicore II System by InnoBioSurg Co., Ltd. K200753, IBS Implant System II by InnoBioSurg Co., Ltd.
Indication for Use:
The IBS System is intended to replace missing teeth to restore chewing function. The IBS 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.
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}------------------------------------------------
Device Description
The fixtures and abutments in this system are below:
- Fixture
- Magicore (RBM)
- Magicore (RBM Cutting Edge)
- Magicore II (SLA) .
- Magicore II (SLA Cutting Edge)
-
- Abutment
- Magic Angled Abutment (Screw type _Hex, Non-Hex) ●
- Magic Motion
- Magic Motion Housing ●
- Magic Abutment (Screw type Hex, Non-Hex & Cement type Hex, Non-Hex) ●
- Magic Multiunit Abutment (Cement type Hex, Non-Hex)
- Magic Multiunit Cap .
An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The implant-abutment connection is tight and precise fitting with internal hex, non-hex and Morse taper bevel. The surface of the Magicore implant is treated with RBM (Resorbable Blasted media) and Magicore II implants are treated with SLA(sand-blasted, large-grit, acid-etched).
Below is the fixture dimension range:
| Fixture | PlatformDiameters (Ø) | FixtureDiameters (Ø) | Cuff Lengths(mm) | Implantable Lengths(mm) |
|---|---|---|---|---|
| Magicore (RBM) | 5.7 | 7.0 | 1.0, 2.0, 3.0,4.0 | 11.0 ,12.0 ,13.0 |
| Magicore (RBM_ Cutting Edge) | 7.5 | 10.0, 11.0, 12.0, 13.0 | ||
| 8.0 | 9.0, 10.0, 11.0, 12.0, 13.0 | |||
| Magicore II (SLA)Magicore II (SLA_ Cutting Edge) | 5.7 | 7.0, 7.5, 8.0 | 1.0, 2.0, 3.0,4.0 | 7.0, 8.0, 9.0, 10.0, 11.0,12.0, 13.0 |
The subject fixtures are provided sterile.
Below is the abutment dimension range:
| Abutments | Uses | Diameter(Ø) | Total Length(mm) | Angle(°) | Surface |
|---|---|---|---|---|---|
| Magic AngledAbutment(Screw type _Hex,Non-Hex) | The Abutment is connectedwith fixture and it supportsprosthesis which restorestooth function. | 5.3 | 8.45, 8.96, 9.45,9.96, 10.45, 10.96,11.45, 11.96 | 15, 23 | machined |
| 6.3 | 8.68, 9.32, 9.68,10.32, 10.68,11.32, 11.68, 12.32 | ||||
| Magic Motion | The Magic MotionAbutment is connectedwith fixture and replacemissing teeth to restorechewing function. | 4.0 | 10.61, 11.11,11.56, 12.06,12.11, 13.06,13.11, 14.06,14.11, 15.06 | - | machined |
| Magic MotionHousing | The Magic MotionHousing is connected withmagic motion and replacemissing teeth to restorechewing function. | 5.16 | 3.3 | - | machined |
{5}------------------------------------------------
| Magic Abutment(Screw type _ Hex,Non-Hex) | The Abutment is connectedwith fixture and it supportsprosthesis which restorestooth function. | 5.2, 5.7,6.2, 6.7 | 4.51, 5.51, 6.51,7.51,8.51 | - | RBM(Blasting) |
|---|---|---|---|---|---|
| Magic Abutment(Cement type _Hex, Non-Hex) | The Abutment is connectedwith fixture and it supportsprosthesis which restorestooth function. | 5.2, 5.7,6.2, 6.7 | 6.5, 7.5, 8.5, 9.5,10.5 | - | RBM(Blasting) |
| Magic MultiunitAbutment(Cement type _Hex, Non-Hex) | The Abutment is connectedwith fixture and it supportsprosthesis which restorestooth function. | 4.8 | 5.7, 6.7, 7.7, 8.7 | 0, 5, 10 | RBM(Blasting) |
| 5.66, 6.66, 7.66,8.66 | 15 | ||||
| 6.0, 7.0, 8.0, 9.0 | 20 | ||||
| 6.237, 7.237,8.237, 9.237 | 25 | ||||
| 5.8 | 5.76, 6.76, 7.76,8.76 | 0, 5, 10 | |||
| 5.69, 6.69, 7.69,8.69 | 15 | ||||
| 5.96, 6.96, 7.96,8.96 | 20 | ||||
| 6.344, 7.334,8.334, 9.344 | 25 | ||||
| Magic MultiunitCap | Caps lead to accurateclosure of soft tissuesurrounding implant andprovide a definite shapeand form to gingiva whichis aesthetically close tonatural look. | 5.4, 6.4 | 4.3 | - | RBM(Blasting) |
The abutments are provided non-sterile and packaged separately. The abutments should be sterilized before use by End User sterilization.
Materials:
- The Magicore, Magicore II fixtures, Magic Angled Abutment, Magic Motion Housing, Magic . Abutment, Magic Multiunit Abutment and Magic Multiunit cap are made of Ti-6Al-4V ELI
- . The Ball Pin of the Magic Motion is made of Ti-6Al-4V ELI and the body of the Magic Motion is made of Co-Cr-Mo Alloy.
{6}------------------------------------------------
Summaries of Technological Characteristics & Substantial Equivalence Discussion
| 1) Magicore and Magicore II Fixtures | |||
|---|---|---|---|
| Subject Device | Primary predicate | Reference predicate | |
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd |
| Device Name | IBS System | Magicore System | Magicore II System |
| 510(k) No. | K220517 | K212517 | K192197 |
| Indications for use | The IBS Implant System isintended to replace missingteeth to restore chewingfunction. The IBS ImplantSystem can be placed insupport of single or multiple-unit restorations including;cement retained, screwretained, or overdenturerestorations, and terminal orimmediate abutment supportfor fixed bridgework. Thissystem is for one or two stagesurgical procedures. Thissystem is intended fordelayed loading. | The Magicore System isintended to replace missingteeth to restore chewingfunction. The MagicoreSystem can be placed insupport of single or multiple-unit restorations including;cement retained, screwretained, or overdenturerestorations, and terminal orimmediate Abutment supportfor fixed bridgework. Thissystem is for one or two stagesurgical procedures. Thissystem is intended fordelayed loading. | The Magicore II System isintended to replace missingteeth to restore chewingfunction. The Magicore IISystem can be placed insupport of single ormultipleunit restorationsincluding; cement retainedscrew retained, oroverdenture restorations,and terminal or immediateabutment support for fixedbridgework. This system isfor one or two stagesurgical procedures. Thissystem is intended fordelayed loading |
| Design | Image: Magicore | Image: Magicore II | Image: Magicore II |
| Cutting EdgeNon-Cutting Edge | Cutting EdgeNon-Cutting Edge | Cutting EdgeNon-Cutting Edge | |
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Connection | Internal HexNon - Submerged | Internal HexNon - Submerged | Internal HexNon - Submerged |
| Endosseous Implant | Tapered, macro threads | Tapered, macro threads | Tapered, macro threads |
| PlatformDiameters (Ø) | 5.7 | 5.2 | 4.7, 5.2, 5.7 |
| FixtureDiameters (Ø) | 7.0, 7.5, 8.0 | 5.0, 5.5,6.0, 6.5 | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
| Cuff Lengths(mm) | 1.0, 2.0, 3.0, 4.0 | 1.0, 2.0, 3.0, 4.0 | 0, 1.0, 2.0, 3.0, 4.0, 5.0,6.0, 7.0, 8.0, 9.0, 10.0 |
| ImplantableLengths (mm) | 11.0, 12.0,13.010.0, 11.0,12.0, 13.09.0, 10.0,11.0, 12.0,13.0 | 7.0, 8.0, 9.0,10.0, 11.0,12.0, 13.0 | 7.0, 8.0, 9.0, 10.0, 11.0,12.0, 13.0 |
| Surface | R.B.M | S.L.A | S.L.A |
| Treatment | R.B.M | ||
| SurgicalTechnique | 1 and 2 stage, self-tapping | 1 and 2 stage, self-tapping | 1 stage and 2 stage, selftapping |
| GammaSterilization | Yes | Yes | Yes |
| SE Discussion | The subject IBS System has same indications for Use, material, surface treatment,connection, general shape (Design), surface structure, applied production method andsurgical technique as the Primary Predicate, K212517. For SLA surface treatment andMagicore II fixture's design of the subject device, K192197 was added as a referencedevice. Therefore, subject device and predicate devices are substantially equivalent. |
1) Magicore and Magicore II Fixtures
{7}------------------------------------------------
- Abutment
<Magic Angled Abutment (Screw type _Hex, Non-Hex)>
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd. | Neobiotech Co., Ltd. |
| Device Name | IBS System | CMI Implant IS System |
| Abutment Name | Magic Angled Abutment | IS Angled Abutment |
| 510(k) No. | K220517 | K181138 |
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI |
| Design | Image: [Subject Device Design] | Image: [Reference Device Design] |
| Diameter(⌀) | 5.36.3 | 4.5, 5.2, 5.7, 6.5 |
| Length(mm) | 7.5, 8.037.73, 8.37 | 7.0, 8.0 |
| Angle (°) | 15, 23 | 15, 25 |
| Surface Treatment | Machine- | Tin Coating |
| Sterilization | End User Sterilization | End User Sterilization |
| SE Discussion | The subject device is similar in indications for Use, fundamental scientific technology, principle of operation, technology, functions, and materials with the identified reference device.The difference between the subject and reference device is the general design. However, it does not affect device's fundamental functions and safety; therefore, it is substantial equivalent. |
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd. |
| Device Name | IBS System | CCM Abutment System | IBS Implant System II |
| Product Name | Magic Motion | UCLA Abutment | Magic motion |
| 510(k) No. | K220517 | K173120 | K200753 |
| Material | Ball Pin (TI-6AL-4V ELI)Body (Co-Cr-Mo Alloy) | POM(Poly Acetal)Co-Cr-Mo Alloy | Titanium Alloy(ASTM F 136) |
| Design | Image: Subject Device Design | Image: Reference Device Design | Image: Reference Device Design |
{8}------------------------------------------------
| Diameters ( $ø$ ) | 4.0 | 4.0, 4.5, 5.0, 5.5 | 4.0 |
|---|---|---|---|
| Total Length (mm) | 10.61, 11.11, 11.56, 12.06,12.11, 13.06, 13.11, 14.06,14.11, 15.06 | 14.0, 15.0, 16.0, 17.0 | 10.05~16.05 |
| SurfaceTreatment | Machine- | N/A | Machine- |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
| SE Discussion | The subject device is similar in indications for Use, fundamental scientific technology,principle of operation, general design, technology, functions, and materials (Ball pin) withthe identified reference device.The difference between the subject and reference device is the head(Ball Pin) shapechanged to more round. This difference is to improve the connection of Magic Motion andMagic Motion Housing and doesn't impact product's substantial equivalence. And theBody materials changed Co-Cr-Mo Alloy. To support the materials, K173120 was addedas a reference device. This difference is to improve strength doesn't affect device'sfundamental functions and safety; therefore, it is substantial equivalent. |
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | IBS System | IBS Implant System II |
| Product Name | Magic Motion | Magic motion |
| 510(k) No. | K220517 | K200753 |
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameters (⌀) | 5.16 | 5.3 |
| Total Length (mm) | 3.3 | 3 |
| SurfaceTreatment | Machine- | Machine- |
| Sterilization | End User Sterilization | End User Sterilization |
| SE Discussion | The subject device is same in indications for Use, fundamental scientific technology,principle of operation, general design, technology, functions, and materials with theidentified reference device.The difference between the subject and reference device is diameters and length.The height and diameter are changed from K200753 however, it doesn't impact product'ssafety and effectiveness. Therefore, it is substantially equivalent. |
{9}------------------------------------------------
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | IBS System | Magicore System | Magicore System |
| Product Name | Magic Abutment | Magic Abutment | Magicore |
| 510(k) No. | K220517 | K212517 | K152520 |
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI | TI-6AL-4V ELI |
| Design | Image: Hex designImage: Non-Hex design | Image: Hex designImage: Non-Hex design | Image: Screw design |
| Diameters (Ø) | 5.2, 5.7, 6.2, 6.7 | 5.2, 5.7, 6.2, 6.7 | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
| Total Length(mm) | 4.51, 5.51, 6.51, 7.51, 8.51 | 4.51, 5.51, 6.51, 7.51, 8.51 | 7.0~13.0 |
| Surface Treatment | RBM(Blasting) | Machine- | RBM |
| Sterilization | End User Sterilization | End User Sterilization | Gamma Sterilization |
| SE Discussion | |||
| The subject device is same in fundamental scientific technology, technology, materials, dimensions, and design with the primary predicate.The difference between the subject and primary device is the surface treatment and sterilization. To support these discrepancies, K152520 was added as reference device. The surface treatment between the subject device and K152520 is exactly same.This surface change is intended to only improve scanning surface area and does not affect the actual equivalence of the product. Therefore, it is substantially equivalent. |
<Magic Abutment (Screw type _ Hex, Non-Hex)>
| <Magic Abutment (Cement type _ Hex, Non-Hex)>Subject Device | Primary Predicate | Reference Device | |||
|---|---|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | ||
| Device Name | IBS Implant System | Magicore System | Magicore System | ||
| Product Name | Magic Abutment | Magic Abutment | Magicore | ||
| 510(k) No. | K220517 | K212517 | K152520 | ||
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI | TI-6AL-4V ELI | ||
| Design | Image: Hex Design | Image: Non-Hex Design | Image: Hex Design | Image: Non-Hex Design | Image: Screw Design |
| Hex | Non-Hex | Hex | Non-Hex | ||
| Diameters (ø) | 5.2, 5.7, 6.2, 6.7 | 5.2, 5.7, 6.2, 6.7 | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | ||
| Total Length(mm) | 6.5, 7.5, 8.5, 9.5, 10.5 | 6.5, 7.5, 8.5, 9.5, 10.5 | 7.0 ~13.0 | ||
| SurfaceTreatment | RBM(Blasting) | Machine- | RBM | ||
| Sterilization | End User Sterilization | End User Sterilization | Gamma Sterilization | ||
| SE Discussion | The subject device is same in fundamental scientific technology, technology, materials,dimensions, and design with the primary predicate.The difference between the subject and primary device is the surface treatment andsterilization. To support these discrepancies, K152520 was added as reference device. Thesurface treatment between the subject device and K152520 is exactly same.This surface change is intended to only improve scanning surface area and does not affectthe actual equivalence of the product. Therefore, it is substantially equivalent. |
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| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | IBS Implant System | Magicore System | Magicore System |
| Product Name | Magic Multiunit Abutment | Magic Multiunit Abutment | Magicore |
| 510(k) No. | K220517 | K212517 | K152520 |
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI | TI-6AL-4V ELI |
| Design | HexNon-Hex | HexNon-Hex | |
| Diameters (Ø) | 4.8, 5.8 | 4.8, 5.8 | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
| Angulation (°) | 0, 5, 10, 15, 20, 25 | 0, 5, 10, 15, 20, 25 | 7.0~13.0 |
| SurfaceTreatment | RBM(Blasting) | Machine- | RBM |
| Sterilization | End User Sterilization | End User Sterilization | Gamma Sterilization |
| SE Discussion | The subject device is same in fundamental scientific technology, technology, materials,dimensions and design with the primary predicate.The difference between the subject and primary device is the surface treatment andsterilization. To support these discrepancies, K152520 was added as reference device. Thesurface treatment between the subject device and K152520 is exactly same.This surface change is intended to only improve scanning surface area and does not affect theactual equivalence of the product. Therefore, it is substantially equivalent. | ||
| Subject Device | Reference Device | Reference Device | |
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | IBS Implant System | Magicore System | Magicore System |
| Product Name | Magic Multiunit Cap | Magic Multiunit Cap | Magicore |
| 510(k) No. | K220517 | K212517 | K152520 |
| Material | TI-6AL-4V ELI | TI-6AL-4V ELI | TI-6AL-4V ELI |
| Design | |||
| Diameters (Ø) | 5.4, 6.4 | 5.4, 6.4 | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
| Total Length(mm) | 4.3 | 4.3 | 7.0~13.0 |
| SurfaceTreatment | RBM(Blasting) | Machine- | RBM |
| Sterilization | End User Sterilization | End User Sterilization | Gamma Sterilization |
Magic Multiunit Abutmont(Co n
dimensions and design with the primary predicate. The difference between the subject and primary device is the surface treatment. SE Discussion To support these discrepancies, K152520 was added as reference device. The surface treatment between the subject device and K152520 is exactly same. This surface change is intended to only improve scanning surface area and does not affect the actual equivalence of the product. Therefore, it is substantially equivalent.
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Non-Clinical Data:
Below tests were performed on the subject device:
- End User Sterilization Validation Test Report on Abutments made of Titanium ELI with ● RBM(Blasting) Surface treatment according to ANSVAAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1
- . Biocompatibility testing according to the ISO10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, and ISO 10993-10:2010 on abutments made of Titanium ELI with RBM(Blasting) Surface treatment.
Below tests were performed for predicate devices and leveraged for the subject device:
- 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 & K162099
- Biocompatibility testing according to ISO 10993-1:2009. ISO 10993-5:2009. ISO 10993-● 6:2007, and ISO 10993-10:2010 on abutments made of Titanium ELI referenced in K140806 & on Abutments made of CCM alloy referenced in K173120
- LAL information/testing per USP <85> as referenced in K162099
- Sterilization validation for devices on Fixtures according to ISO 11137-1 and ISO 11137-2
- . Shelf Life Test Report on Fixture and Magicore Cap according to ASTM F1980
- End User Sterilization Validation Test Report on Abutments made of Titanium ELI according to . ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K192197
- Fatigue Testing according to ISO 14801:2016 referenced in K212517 ●
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) and SLA(sand-blasted, large-grit, acid-etched)was provided. To compare surface modification between the subject and predicate devices, K152520 and K162099, surface roughness, surface composition analysis, and SEM imaging were provided, and it demonstrate the substantial equivalence.
The end user sterilization validation testing was performed on abutment made of Titanium ELI with RBM(Blasting) Surface treatment under the worst-case construction. This sterilization cycle has been validated by the overkill method to a sterility assurance level (SAL) of 10-6 according to ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
The biocompatibility testing was performed on abutments made of Titanium ELI with RBM(Blasting) Surface treatment according to the ISO10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and it demonstrate the subject abutments are biocompatible.
Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments".
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-
Performance testing of Fixture Packaging -
Below performance testing and information have been provided for subject implant fixture packaging: -
Human Factors testing (A usability evaluation for aseptic presentation of the subject device, in line with ISO 11607-1:2019 and the recommendations of the FDA guidance document, "Applying Human Factors and Usability Engineering to Medical Devices.")
-
. Low and high magnification images at various degrees of rotation following the removal from the packaging (Evaluation of the broken tip at various degrees rotation at a high magnification and low magnification for damage after removal from the packaging and disconnection of the fixture jig)
-
. Quality System (QS) plan including the method and frequency of acceptance activities to ensure that the devices conform with product specifications with packaging design.
Conclusion
The IBS 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, IBS System and its predicates are substantially equivalent.
§ 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.