(26 days)
No
The summary describes a dental implant system and its components, focusing on materials, design, and mechanical testing. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is intended to replace missing teeth to restore chewing function, which addresses a physiological dysfunction (missing teeth) and returns the body to a normal or improved state (restored chewing function).
No
Explanation: The device, IBS Implant System, is intended to replace missing teeth and restore chewing function. It is a dental implant system used for surgical procedures and restorations, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of dental implants, abutments, and screws, which are physical hardware components. The performance studies also detail testing related to these physical components (sterilization, biocompatibility, fatigue testing, etc.).
Based on the provided text, 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 consists of "dental implants, abutments, and screws." These are physical components implanted into the jawbone.
- Lack of IVD Characteristics: The description does not mention any components or processes related to testing samples in vitro (outside the body), such as reagents, calibrators, controls, or analysis of biological specimens.
- Anatomical Site: The anatomical site is "Missing teeth," which is a location within the human body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a physical implant used for structural support and restoration within the body.
N/A
Intended Use / Indications for Use
The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant can be placed in support of single or 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 and not for immediate loading. 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 implants and abutments to the previously cleared device, IBS Implant System (K153350). An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The IBS Implant System consists of dental implants, abutments, 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).
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:
- Sterilization validation for devices provided sterile per ISO 11137-1 and ISO 11137-2 referenced in K153350
- LAL information/testing per USP as referenced in K162099
- Shelf Life Test on Fixtures according to ASTM F1980 referenced in K152520
- Biocompatibility testing according to ISO 10993-1:2009. ISO 10993-3:2014. ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures referenced in K140806, K152520 and K162099
- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, and ISO 10993-10:2010 on abutments referenced in K140806 and K173120
- End User Sterilization Validation Test Report according to ANSVAAMI 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 referenced in K153350
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. K153350, 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 predicate device remains as worst-case based on the dimensional worst-case analysis. 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.
K113554, K140806, K150344, K152520, K162099, K172100, K173120, K173141, K182448, K192197
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 23, 2020
InnoBioSurg Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K202479
Trade/Device Name: IBS Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 28, 2020 Received: August 28, 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 (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,
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202479
Device Name IBS Implant System
Indications for Use (Describe)
The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutunent support for fixed bridgework. This system is for one or two stage surgical procedures and not for immediate loading. This system is intended for delayed loading.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 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. 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: IBS Implant System
- . Common Name: Endosseous dental implant
- Classification Name: Endosseous dental implant ●
- Primary Product Code: DZE
- Secondary Product Code: NHA
- Panel: Dental
- Regulation Number: 872.3640
- Device Class: Class II
- Date prepared: 09/22/2020
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate K153350, IBS Implant System manufactured by InnoBioSurg Co., Ltd.
Reference Device K113554, CMI Implant IS System by Neobiotech Co., Ltd. K140806. IBS Implant System by InnoBioSurg Co., Ltd. K150344, Dentis Dental Implant System by Dentis Co., Ltd. K152520, Magicore System by InnoBioSurg Co., Ltd. K162099, IBS Implant System II by InnoBioSurg Co., Ltd. K172100, URIS OMNI System by TruAbutment Korea Co., Ltd. K173120, CCM Abutment System by InnoBioSurg Co., Ltd. K173141, CSM Submerged3-L Implant System by CSM Implant K182448, Any Ridge Octa 1 System by MegeGen Implant Co., Ltd. K192197, Magicore II System by InnoBioSurg Co., Ltd.
Indication for Use
The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures and not for immediate loading. This system is intended for delayed loading.
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General Description
This submission is to add implants and abutments to the previously cleared device, IBS Implant System (K153350).
An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The IBS Implant System consists of dental implants, abutments, 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).
| Fixture | Diameters (Ø) | Length (mm) |
|---|---|---|
| NR Fix | ||
| (Addition to K153350) | 3.5 | 10, 11, 12, 13, 14 |
| (Length of Surface treatment: 10, 12) | ||
| 3.8 | 10, 11, 12, 13, 14 | |
| (Length of Surface treatment: 10, 12) | ||
| Magic FC Mini | ||
| (Newly Added) | 3.55 | 9, 10, 11, 12, 13 |
| Magic FC | ||
| (Addition to K153350) | 4 | 8, 10, 12, 14 |
| 4.5 | 8, 10, 12, 14 | |
| 5 | 8, 10, 12, 14 | |
| 5.5 | 8, 10, 12, 14 | |
| 6 | 8, 10, 12, 14 | |
| 6.5 | 8, 10, 12, 14 | |
| Magic FC | ||
| (Cutting Edge) | ||
| (Addition to K153350) | 4 | 8, 10, 12, 14 |
| 4.5 | 8, 10, 12, 14 | |
| 5 | 8, 10, 12, 14 | |
| 5.5 | 8, 10, 12, 14 | |
| 6 | 8, 10, 12, 14 | |
| 6.5 | 8, 10, 12, 14 |
Below is Fixture dimension range:
Below is abutment dimension range:
| Abutments | Diameters (Ø) | Angle (°) | Length (mm) |
|---|---|---|---|
| Angled Abutment | |||
| (Addition to K153350) | 4.5 | 15 | 11.4, 12.4, 13.4, 14.4 |
| 4.5 | 25 | 11.65, 12.65, 13.65, 14.65 | |
| 4.95 | 15 | 11.4, 12.4, 13.4, 14.4 | |
| 4.95 | 25 | 11.65, 12.65, 13.65, 14.65 | |
| Pair Abutment | |||
| (Addition to K153350) | 3.95, 4.5, 4.95, | ||
| 5.5, 5.95, 6.5 | 0 | Post Height: 4, 5.5, 6, 7, 7.5 | |
| Multiunit Abutment | |||
| (Addition to K153350) | 4.8 | 0, 17, 30 | 6.21, 6.76, 7.21, 7.76, 8.21, 8.76, 9.21, |
| 9.76, 10.1, 10.21, 10.76, 11.1, 12.1, | |||
| 13.1, 14.1 | |||
| Multiunit Abutment Screw | |||
| (Newly Added) | 2.2 | 0 | 6.5 |
| Multiunit Abutment Cap | |||
| (Addition to K153350) | 4.8 | 0 | 6 |
| Temporary Abutment | |||
| (Newly Added) | 4.5 | 0 | 13.1 |
5
| Multiunit Abutment Temporary
| Cylinder (Newly Added) | 4.8 | 0 | 12 |
|---|---|---|---|
| Multiunit Abutment Plastic Cylinder | |||
| (Newly Added) | 4.8 | 0 | 12 |
| Multiunit Abutment CCM Cylinder | |||
| (Newly Added) | 4.8 | 0 | 12 |
| Closing Screw | |||
| (Newly Added) | 3.0 | 0 | 4.8 |
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 Angled Abutment, Pair Abutment, Multiunit Abutment, Multiunit Abutment Screw, Multiunit Abutment Cap, Temporary Abutment, Multiunit Abutment Temporary Cylinder, Multiunit Abutment Plastic Cylinder, and Multiunit Abutment CCM Cylinder are supplied non-sterile and should be sterlized before use.
The purpose of this submission is
- To add NR Fix Ø3.5, 3.8 X 10, 11, 12, 13, 14mm of total length with length of surface treatment 10, 12mm.
- . To add Magic FC Mini.
- To add Magic FC Ø4, 4.5, 5, 5.5, 6, 6.5 X 8, 10, 12, 14mm.
- To add Magic FC (Cutting Edge) ø4. 4.5. 5. 5.5. 6. 6.5 X 8. 10. 12. 14mm.
- To change the product codes of the previously cleared NR Fix and Magic FC by adding "B" at ● the end of the product code.
- . To change the product codes of the previously cleared Angled Abutment, Pair Abutment, and Multiunit Abutment by adding "B" at the end of the product codes.
- . To add Angled Abutment @4.5, 4.95 X 11.4, 11.65, 12.4, 13.65, 14.4, 14.65mm.
- To add Pair Abutment Ø3.95, 4.5, 4.95, 5.5, 5.95, 6.5 X Post Heights 4, 5.5, 6, 7, 7.5mm. ●
- To add Multiunit Abutment @4.8mm X 6.21, 6.76, 7.21, 7.76, 8.21, 8.76, 9.21, 9.76, 10.1, 10.21, 10.76, 11.1, 12.1, 13.1, 14.1mm.
- To add Multiunit Abutment Screw.
- To add Multiunit Abutment Cap Ø4.8 X 6mm. ●
- To add Temporary Abutment.
- To add Multiunit Abutment Temporary Cylinder. ●
- To add Multiunit Abutment Plastic Cylinder.
- To add Multiunit Abutment CCM Cylinder.
- To add Closing Screw. ●
Materials:
Fixtures, Angled Abutment, Pair Abutment, Multiunit Abutment, Temporary Abutment and Multiunit Abutment Temporary Cylinder are fabricated from Ti-6AL-4V Eli (Conforming to ASTM Standard F-136).
Multiunit Abutment Plastic Cylinder is fabricated from Poly Diacetate. Multiunit Abutment CCM Cylinder is fabricated from Poly Diacetate, Co-Cr-Mo (Cobalt Chromium Molybdenum).
6
Summaries of Technology Characteristics:
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | IBS Implant System | IBS Implant System |
| 510(k) No. | N/A | K153350 |
| Indications for use | The IBS Implant System is intended to replace missing teeth | |
| to restore chewing function. The IBS Implant System can be | ||
| placed in support of single or multiple-unit restorations | ||
| including; cement retained, screw retained, or overdenture | ||
| restorations, and terminal or immediate abutment support for | ||
| fixed bridgework. This system is for one or two stage surgical | ||
| procedures and not for immediate loading. This system is | ||
| intended for delayed loading. | The IBS Implant System is intended to replace missing teeth | |
| to restore chewing function. The IBS Implant System can be | ||
| placed in support of single or multiple-unit restorations | ||
| including; cement retained, screw retained, or overdenture | ||
| restorations, and terminal or immediate abutment support for | ||
| fixed bridgework. This system is for one or two stage surgical | ||
| procedures and not for immediate loading. This system is | ||
| intended for delayed loading. | ||
| Design | Cutting Edge | Cutting Edge |
| Material | Titanium Alloy (Ti-6Al-4V Eli) ASTM F136 | Titanium Alloy (Ti-6Al-4V Eli) ASTM F136 |
| Connection | Internal Hex, Submerged | Internal Hex, Submerged |
| Endosseous Implant | Tapered, Macro threads | Tapered, Macro threads |
| Diameters (Ø) | 3.5, 3.8 | 3.5, 3.8 |
| Lengths (mm) | 10, 11, 12, 13, 14 | 9, 10, 11, 12, 13, 14, 15 |
| D X L (Surface Tx L) | ||
| (implants feature a non- | ||
| blasted collar of 0, 1, | ||
| and 2 mm lengths) | 3.5 X 10 (10) | |
| 3.5 X 12 (12) | ||
| 3.8 X 12 (10) | ||
| 3.8 X 11 (10) | ||
| 3.8 X 13 (12) | ||
| 3.8 X 14 (12) | 3.5 X 9 (9) | |
| 3.5 X 11 (11) | ||
| 3.5 X 13 (13) | ||
| 3.8 X 11 (9) | ||
| 3.8 X 13 (11) | ||
| 3.8 X 15 (13) | ||
| 3.8 X 10 (9) | ||
| 3.8 X 12 (11) | ||
| 3.8 X 14 (13) | ||
| Modified Surface | RBM | RBM |
| Surgical Technique | 1 stage and 2 stage, Self tapping | 1 stage and 2 stage, Self tapping |
| Gamma Sterilization | Yes | Yes |
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The NR Fix is substantially equivalent with the Primary predicate such as indications for Use, diameters, Length, surface treatment method, material, functions, general shape (Design), structure and applied production method.
Differences
The difference between the subject and predicate device is the surface treatment. Compared to the predicate device, the subject's device's length of surface treatment is 10 and 12mm. Since treatment length of subject device is included in range of primary predicate's surface treatment length, therefore, it doesn't impact product's substantial equivalence.
| Subject Device | Primary Predicate | ||
|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | |
| Device Name | IBS Implant System | IBS Implant System | |
| 510(k) No. | N/A | K153350 | |
| Indications for use | The IBS Implant System is intended to replace | ||
| missing teeth to restore chewing function. The IBS | |||
| Implant System can be placed in support of single or | |||
| multiple-unit restorations including; cement retained, | |||
| screw retained, or overdenture restorations, and | |||
| terminal or immediate abutment support for fixed | |||
| bridgework. This system is for one or two stage | |||
| surgical procedures and not for immediate loading. | |||
| This system is intended for delayed loading. | The IBS Implant System is intended to replace missing teeth to | ||
| restore chewing function. The IBS Implant System can be placed in | |||
| support of single or multiple-unit restorations including; cement | |||
| retained, screw retained, or overdenture restorations, and terminal or | |||
| immediate abutment support for fixed bridgework. This system is for | |||
| one or two stage surgical procedures and not for immediate loading. | |||
| This system is intended for delayed loading. | |||
| Design | Image: Magic FC Mini | Image: NR Fix | Image: Magic FC |
8
| | Non-Cutting Edge | Cutting Edge | Cutting Edge
Non-Cutting Edge |
|----------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|
| Composition of
Material | Titanium Alloy (Ti-6Al-4V Eli)
ASTM F136 | Titanium Alloy (Ti-6Al-4V Eli)
ASTM F136 | Titanium Alloy (Ti-6Al-4V Eli)
ASTM F136 |
| Connection | Internal Hex, Submerged | Internal Hex, Submerged | Internal Hex, Submerged |
| Endosseous Implant | Tapered, Macro threads | Tapered, Macro threads | Tapered, Macro threads |
| Diameters (ø) | 3.55 | 3.5, 3.8 | 4, 4.5, 5, 5.5, 6, 6.5 |
| Lengths (mm) | 9, 10, 11, 12, 13 | 9, 10, 11, 12, 13, 14, 15 | 7, 9, 11, 13, 15 |
| Modified Surface | RBM | RBM | |
| Surgical Technique | 1 stage and 2 stage, Self tapping | 1 stage and 2 stage, Self tapping | |
| Gamma Sterilization | Yes | Yes | |
The Magic FC Mini is substantially equivalent with the Primary predicate such as indications for Use diament method, material, functions, general shape (Design), structure and applied production method.
Differences
Compared to the Primary predicate, the subject's device is non-cutting-edge functions as self-tapping by creating a screw path. This difference doesn't impact product's substantial equivalence.
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | IBS Implant System | IBS Implant System |
| 510(k) No. | N/A | K153350 |
| Indications for use | The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant System can be placed in support of single or multiple-unit restorations including; cement retained, screw | The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant System can be placed in support of single or multiple-unit restorations including; cement retained, screw |
9
| | retained, or overdenture restorations, and terminal or
immediate abutment support for fixed bridgework. This
system is for one or two stage surgical procedures and
not for immediate loading. This system is intended for
delayed loading. | retained, or overdenture restorations, and terminal or
immediate abutment support for fixed bridgework. This
system is for one or two stage surgical procedures and
not for immediate loading. This system is intended for
delayed loading. |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Image: Implant Design | Image: Implant Design |
| | Cutting Edge, Non-Cutting Edge | Cutting Edge, Non-Cutting Edge |
| Composition of
Material | Titanium Alloy (Ti-6Al-4V Eli) | Titanium Alloy (Ti-6Al-4V Eli) |
| | ASTM F136 | ASTM F136 |
| Connection | Internal Hex | Internal Hex |
| | Submerged | Submerged |
| Endosseous Implant | Tapered, Macro threads | Tapered, Macro threads |
| Diameters (Ø) | 4, 4.5, 5, 5.5, 6, 6.5 | 4, 4.5, 5, 5.5, 6, 6.5 |
| Lengths (mm) | 8, 10, 12, 14 | 7, 9, 11, 13, 15 |
| Modified Surface | RBM | RBM |
| Surgical Technique | 1 stage and 2 stage, Self tapping | 1 stage and 2 stage, Self tapping |
| Gamma Sterilization | Yes | Yes |
The Magic FC is substantially equivalent with the Primary predicate such as indications for Use diament method, material, functions, general shape (Design), structure and applied production method.
Differences
Compared to the Primary predicate, the subject's device's length is different. However, the lengths of subject device are included in range of primary predicate's lengths. Therefore, it doesn't impact product's substantial equivalence.
10
2) Abutments
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd. |
| Device Name | IBS Implant System | IBS Implant System |
| 510(k) No. | N/A | K153350 |
| Composition of | ||
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Design | Image: Subject Device Design | Image: Primary Predicate Design |
| Diameters ( $Ø$ ) | 4.5, 4.95 | 4, 4.5, 5 |
| Length (mm) | 11.4, 11.65, 12.4, 12.65, 13.4, 13.65, 14.4, 14.65 | 10.6, 10.85, 11.4, 11.65, 12.4, 12.65, 13.4, 13.65, 14.4, |
| 14.65 | ||
| Angle (°) | 15, 25 | 15, 25, 30 |
| Surface treatment | Machine | Machine |
| Sterilization | End User Sterilization | End User Sterilization |
Similarities
The Angled Abutment is substantially equivalent with the Primary predicate such as diameters, Length, intended use, material, functions, general shape (Design), structure, angulation and applied production method.
Differences
Compared to the Primary predicate, the diameters and lengths of subject device are different; however, the subject device's dimensions are included in range of primary predicate's. Therefore, it doesn't impact product's substantial equivalence.
11
| Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Device Name | IBS Implant System | IBS Implant System | IBS Implant System |
| 510(k) No. | N/A | K153350 | K140806 |
| 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 Predicate Design |
| Non-hex | Hex | ||
| Diameters ( $ø$ ) | 3.95, 4.5, 4.95, 5.5, 5.95, 6.5 | 3.5, 4, 4.5, 5, 5.5, 6, 6.5 | 4, 4.5, 5, 5.5, 6, 6.5 |
| Post Heights (mm) | 4, 5.5, 6, 7, 7.5 | 6 | 4, 6, 7.5 |
| Surface treatment | Machine | Machine | Machine |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
The Pair Abutment is substantially equivalent with the primary predicate device such as indications for use, fundamental scientific technology, principle of operation, general shape (design), functions, surface treatment and materials.
Differences
Compared to the Primary predicate device 4, 5.5, 7, 7.5mm post heights are added to the new subject system. K140806 was chosen to support the range of the subject device dimension. Therefore, it doesn't impact product's substantial equivalence.
12
| Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd. | Dentis Co., Ltd. |
| Device Name | IBS Implant System | IBS Implant System | Denis Dental Implant System |
| 510(k) No. | N/A | K153350 | K150344 |
| 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 Predicate Design |
| Diameters (ø) | 4.8 | 3.6, 4, 4.5, 5, 5.5, 6 | 4.8 |
| Length (mm) | 6.21, 6.76, 7.21, 7.76, 8.21, 8.76, | ||
| 9.21, 9.76, 10.1, 10.21, 10.76, 11.1, | |||
| 12.1, 13.1, 14.1 | 9, 11, 13, 16 | 6.08, 6.69, 8.08, 8.69 | |
| Angle (°) | 0, 17, 30 | 0, 17, 30 | 17, 30 |
| Surface treatment | Machine | Machine | Machine |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
Similarities
The Multiunit Abutment is substantially equivalent with the Primary predicate such as intended use, material, functions, general shape (Design), structure, angulation and applied production method.
Differences
Compared to the primary predicate, the subject multiunit abutment has more various lengths. The Reference Predicate MU Angled Abutment (K150344), supports substantial equivalence of the subject device's 4.8 diameter and 6.21, 6.7.21, 7.76, 8.21 lengths. The Primary Predicate Multiunit Abutment (K153350), support rest lengths of the subject device. This difference of raise an issue in performance or safety.
13
| Subject Device | Reference Predicate | ||
|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | Dentis Co., Ltd. | InnoBioSurg Co., Ltd |
| Device Name | IBS Implant System | Dentis Dental Implant System | IBS Implant System |
| 510(k) No. | N/A | K150344 | K140806 |
| Composition of | |||
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Design | Image: IBS Implant | Image: Dentis Dental Implant | Image: IBS Implant |
| Head Diameters (Ø) | 2.2 | 1.98 | 2.5 |
| Length (mm) | 6.5 | 3.7 | 7.6 |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
| Principle of | |||
| operation | Abutment screw is used for securing | ||
| the abutment to the endosseous | |||
| implant. | Abutment screw is used for securing | ||
| the abutment to the endosseous | |||
| implant. | Abutment screw is used for securing | ||
| the abutment to the endosseous | |||
| implant. |
Similarities
The Multiunit Abutment Screw is substantially equivalent in intended use, general shape, material, Sterilization and Principle of operation as the predicates.
Differences
K150344 and K140806 were added as reference device to support the substantial equivalence of dimensions differences. Although the reference device's dimensions are not exactly same as the subject device, it does not cause a matter in substantial equivalence since the size difference is very minor. The reduced diameter is in the threaded retention area which could potentially affect mechanical performance. Therefore, the difference doesn't impact product's substantial equivalence and no additional fatigue testing was necessary.
14
| Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd. | Neobiotech Co., Ltd. |
| Device Name | IBS Implant System | IBS Implant System | CMI Implant IS System |
| 510(k) No. | N/A | K153350 | K113554 |
| Composition of | |||
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli | POM |
| Design | Image: Implant design | Image: Implant design | Image: Implant design |
| Diameters (ø) | 4.8 | 4.95, 5.35, 5.85, 6.35, 6.85, 7.35 | 4.5, 5.2, 5.7, 6.5 |
| Length (mm) | 6 | 4.95, 6.75, 8.8, 11.9 | 4.5, 5.5, 6, 7, 8 |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
Similarities
The Multiunit Abutment Cap is substantially equivalent in intended use, fundamental scientific technology, principle of operation, design, functions, materials as the identified predicates.
Differences
Compared to the Primary predicate device, the diameter and length range of the subject device are different. K113554 was added to support this discrepancy. Therefore, the difference doesn't impact product's substantial equivalence.
15
| Subject Device | Reference Predicate | ||||
|---|---|---|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd. | CSM Implant | ||
| Device Name | IBS Implant System | CCM Abutment System | CSM Submerged3-L | ||
| Implant System | |||||
| 510(k) No. | N/A | K173120 | K173141 | ||
| Composition of | |||||
| Material | Ti-6Al-4V Eli | Poly Diacetate, Co-Cr-Mo | Ti-6Al-4V Eli | ||
| Design | Image: IBS Implant System | Image: CCM Abutment System | Image: CSM Submerged3-L Implant System | ||
| Diameters (Ø) | 4.5 | 4, 4.5, 5, 5.5, 6 | 4.5, 5.5 | ||
| Length (mm) | 13.1 | 14, 15, 16, 17 | 12.8, 13.3, 13.8, 14.8, | ||
| 15.8, 16.8 | |||||
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
Similarities
The Temporary Abutment is substantially equivalent in intended use, fundamental scientific technology, principle of operation, design, functions, and materials as the identified predicates.
Differences
Compared to the predicate devices, the dimensions and design are slightly different. However, the subject device dimensions are in range of the predicate's and the design difference doesn't change product fundamental characteristics and application. Therefore, do not impact product's substantial equivalence.
16
| Subject Device | Reference Predicate | |
|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd |
| Device Name | IBS Implant System | IBS Implant System II |
| 510(k) No. | N/A | K162099 |
| Composition of | ||
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Design | Image: Implant Design | Image: Implant Design |
| Diameters (ø) | 4.8 | 3.5, 4, 4.5, 5, 5.5, 6 |
| Length (mm) | 12 | 12 |
| Sterilization | End User Sterilization | End User Sterilization |
Similarities
The Multiunit Abutment Temporary Cylinder is substantially equivalent in intended use, fundamental scientific technology, principle of operation, design, functions and materials as the identified predicate.
Differences
Compared to the predicate device, the different, however, the diameter of the subject device is in range of the reference device's. Therefore, the difference doesn't impact product's substantial equivalence.
17
| Subject Device | Reference Predicate | |
|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd |
| Device Name | IBS Implant System | IBS Implant System II |
| 510(k) No. | N/A | K162099 |
| Composition of | ||
| Material | Poly Diacetate | Poly Diacetate |
| Design | Image: Implant Design | Image: Implant Design |
| Diameters (ø) | 4.8 | 3.5, 4, 4.5, 5, 5.5, 6 |
| Length (mm) | 12 | 12 |
| Sterilization | End User Sterilization | End User Sterilization |
Similarities
The Multiunit Abutment Plastic Cylinder is substantially equivalent in intended use, fundamental scientific technology, principle of operation, design, functions and materials as the identified predicate.
Differences
Compared to the predicate device, the different, however, the diameter of the subject device is in range of the reference device's. Therefore, the difference doesn't impact product's substantial equivalence.
18
| Subject Device | Reference Predicate | |
|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd |
| Device Name | IBS Implant System | IBS Implant System II |
| 510(k) No. | N/A | K162099 |
| Composition of | ||
| Material | Poly Diacetate, Co-Cr-Mo | Ti-6Al-4V Eli |
| Design | Image: Implant Design | Image: Implant Design |
| Diameters (ø) | 4.8 | 3.5, 4, 4.5, 5, 5.5, 6 |
| Length (mm) | 12 | 12 |
| Sterilization | End User Sterilization | End User Sterilization |
Similarities
The Multiunit Abutment CCM Cylinder is substantially equivalent in intended use, fundamental scientific technology, principle of operation, design, functions and materials as the identified predicate.
Differences
Compared to the predicate device, the different, however, the diameter of the subject device is in range of the reference device's. Therefore, the difference doesn't impact product's substantial equivalence.
19
| ------------------------------ | -- |
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd |
| Device Name | IBS Implant System | IBS Implant System |
| 510(k) No. | N/A | K140806 |
| Composition of | ||
| Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli |
| Design | Image: Implant Design | Image: Implant Design |
| Diameters (ø) | 3.0 | 3.4 |
| Length (mm) | 4.8 | 5.65 |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
The Closing Screw has substantially equivalent in intended use, fundamental scientific technology, principle and materials as the identified predicate.
Differences
Compared to the predicate device the different. Although the reference device's dimensions are not exactly same as the subject device, it does not cause a matter in substantial equivalence since difference is very minor. Therefore, the difference doesn't impact product's substantial equivalence.
20
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 for devices provided sterile per ISO 11137-1 and ISO 11137-2 referenced in K153350
- LAL information/testing per USP as referenced in K162099 ●
- Shelf Life Test on Fixtures according to ASTM F1980 referenced in K152520 ●
- Biocompatibility testing according to ISO 10993-1:2009. ISO 10993-3:2014. ISO 10993-● 5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures referenced in K140806, K152520 and K162099
- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, and ISO 10993-10:2010 on abutments referenced in K140806 and K173120
- End User Sterilization Validation Test Report according to ANSVAAMI 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 referenced in K153350 ●
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. K153350, 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 predicate device remains as worst-case based on the dimensional worst-case analysis.
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 IBS Implant 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 Implant System and its predicates are substantially equivalent.