Who is the manufacturer of Magicore Narrow System?

Innobiosurg Co., Ltd. filed the 510(k) submission for Magicore Narrow System (K220079).

What is the FDA product code for Magicore Narrow System?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Magicore Narrow System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Magicore Narrow System?

s-Clean OneQ-SL Narrow Implant System (K161244).

Who can help prepare an FDA 510(k) submission like Magicore Narrow System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Magicore Narrow System

K220079 · Innobiosurg Co., Ltd. · DZE · Dec 14, 2022 · Dental

Device Facts

Record ID	K220079
Device Name	Magicore Narrow System
Applicant	Innobiosurg Co., Ltd.
Product Code	DZE · Dental
Decision Date	Dec 14, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2

Indications for Use

The Magicore Narrow System (3.0, 3.5mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or 3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Device Story

Endosseous dental implant system comprising fixtures, abutments, and screws; used as artificial root structure for tooth replacement or denture stabilization. Fixtures are placed into the jawbone by a clinician; abutments connect to fixtures to support dental prostheses. System features internal hex and Morse taper bevel connections. Fixtures are provided sterile (gamma); some abutments are non-sterile and require end-user sterilization. Device provides stable foundation for prosthetic restoration, potentially improving patient masticatory function and aesthetics. Clinical decision-making relies on clinician assessment of primary stability and occlusal loading requirements.

Clinical Evidence

Bench testing only. Evidence includes shelf-life testing (ASTM F1980), sterilization validation (ISO 11137, ISO 17665), biocompatibility (ISO 10993), and MRI safety assessment based on scientific rationale and literature. Surface modification equivalence supported by SEM imaging, surface roughness, and composition analysis. Human factors/usability testing performed for aseptic presentation.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F-136) and PolyOxyMethylene (Acetal). Design: Tapered endosseous implant with macro threads, internal hex, and Morse taper bevel connection. Surface treatments: RBM (Resorbable Blasted media) or SLA (sand-blasted, large-grit, acid-etched). Sterilization: Gamma (fixtures/closing screws) or end-user (other abutments). Connectivity: Standalone dental implant system.

Indications for Use

Indicated for single tooth replacement of mandibular central/lateral incisors and maxillary lateral incisors; multiple tooth replacement of mandibular incisors (when splinted); and denture stabilization in the anterior mandible and maxilla. Suitable for immediate restoration or immediate function if primary stability is achieved.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

s-Clean OneQ-SL Narrow Implant System (K161244)

Reference Devices

BioHorizons Laser-Lok 3.0 Implant System (K093321)
Magicore System (K152520)
CCM Abutment System (K173120)
Magicore II System (K192197)
Magicore System (K201981)
Magicore System (K212517)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. InnoBioSurg Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620 Re: K220079 Trade/Device Name: Magicore Narrow System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 10, 2022 Received: November 14, 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 mediation-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 I. Steen -S Andrew I. 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220079 Device Name Magicore Narrow System #### Indications for Use (Describe) The Magicore Narrow System (3.0, 3.5mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or - 3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(K) Summary #### Submitter InnoBioSurg Co., Ltd. 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 ### Official Correspondent Withus Group Inc April Lee 106 Superior Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122 #### Device Information - Trade Name: Magicore Narrow 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: 12/13/2022 #### Predicate Devices: The subject device is substantially equivalent to the following Devices: Primary Predicate K161244, s-Clean OneO-SL Narrow Implant System manufactured by Dentis Co., Ltd. #### Reference Device K093321, BioHorizons Laser-Lok 3.0 Implant System by BioHorizons Implant K152520, Magicore System manufactured by InnoBioSurg Co., Ltd. K173120, CCM Abutment System manufactured by InnoBioSurg Co., Ltd. K192197, Magicore II System manufactured by InnoBioSurg Co., Ltd. K201981, Magicore System manufactured by InnoBioSurg Co., Ltd. K212517, Magicore System manufactured by InnoBioSurg Co., Ltd. #### Indications for Use The Magicore Narrow System (3.0, 3.5mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or 3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading. {4}------------------------------------------------ #### Device Description: The fixtures and abutments in this system are below: - 1) Fixture - Magicore Narrow (RBM) ● - . Magicore Narrow (SLA) - 2) Abutment - Short Abutment(Hex, Non-Hex) ● - Magicore Solid Abutment - Magic Abutment (Hex, Non-Hex) ● - Magicore Solid Abutment Cap - Magicore Healing Cap ● - Magicore Healing Cap Screw - Closing Screw ● - Abutment Screw ● An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The Magicore Narrow System consists of dental implants, cylinders, caps 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 Magicore Narrow implant is treated with RBM (Resorbable Blasted media) or SLA(sand-blasted, large-grit, acid-etched). Below is the fixture dimension range: | Fixture | Fixture Diameters (Ø) X Implantable Lengths (mm) | |--------------------------|------------------------------------------------------------------| | Magicore Narrow - RBM | 3.0(Ø) X 11.0, 13.0, 15.0 (mm) 3.5(Ø) X 11.0, 13.0, 15.0 (mm) | | Magicore Narrow -SLA | 3.0(Ø) X 11.0, 13.0, 15.0 (mm) 3.5(Ø) X 11.0, 13.0, 15.0 (mm) | The subject fixtures are provided sterile. Below is the abutment Features and dimension range: | Abutments | Uses | Diameters (Ø) | Length (mm) | Angle (°) | Surface Treatment | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------|----------------------------|--------------|----------------------| | Closing Screw | Closing Screw is placed flush over the top of the implant and the gum is sewn up over it for the period of healing. | 2.75 | 5.2 | 0 | Anodizing | | Short Abutment(Hex, Non-Hex) | The Abutment is connected with fixture and it supports prosthesis which restores tooth function. | 2.8 | 4.2, 5.2, 6.2, 7.2, 8.2 | 0 | N/A | | Magic Abutment(Hex, Non-Hex) | The Abutment is connected with fixture and it supports prosthesis which restores tooth function. | 3.87 | 4.2, 5.2, 6.2, 7.2, 8.2 | 0 | N/A | | | The Abutment is connected with fixture and it supports prosthesis which restores tooth function. | 4.5 | 4.2, 5.2, 6.2, 7.2, 8.2 | 0 | N/A | {5}------------------------------------------------ | Magicore Solid Abutment | The Abutment is connected with fixture and it supports prosthesis which restores tooth function. | 2.8 | 7.2, 8.2, 9.2, 10.2, 11.2 | 0 | N/A | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|------------------------------|---|-----| | Magicore Solid Abutment Cap | The Abutment used to protect abutment inside of the mouth and minimize the feeling of irritation from the patient's mouth. | 4.5 | 5.5, 6.5, 7.5, 8.5, 9.5 | 0 | N/A | | Magicore Healing Cap | Healing caps lead to accurate closure of soft tissue surrounding implant and provide a definite shape and form to gingiva which is aesthetically close to natural look. | 4.6, 4.8 | 5.5, 7.1, 8.0 | 0 | N/A | | Magicore Healing Cap Screw | Connection body to connect abutment to fixture. | 1.8 | 6.4 | 0 | N/A | | Abutment Screw | Connection body to connect abutment to fixture. | 1.8 | 7.0 | 0 | N/A | The Closing Screw, Magicore Healing Cap are supplied sterile by Gamma sterilization. Other abutments are provided non-sterile and packaged separately. The abutments should be sterilized before use by End User sterilization. The Magicore Narrow Fixture is only compatible with the Magicore Narrow Abutments. #### Materials: - Magicore Narrow Fixture and abutments are made of Ti-6A1-4V Eli - - -Magicore Solid Abutment Cap is made of PolyOxyMethylene(=Acetal) {6}------------------------------------------------ # Summaries of Technological Characteristics & Substantial Equivalence Discussion | Fixtures | | |----------|--| | | | | | Subject Device | Primary predicate | Reference Device | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | InnoBioSurg Co., Ltd | Dentis Co., Ltd. | BioHorizons Implant Systems. Inc | | Device Name | Magicore Narrow System | s-Clean OneQ-SL Narrow Implant System | BioHorizons Laser-Lok 3.0 Implant System | | 510(k) No. | K220079 | K161244 | K093321 | | Indications for use | The Magicore Narrow System (3.0, 3.5mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or 3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading. | The s-Clean OneQ-SL Narrow Implant System (3.0, 3.3mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or 3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading. | BioHorizons Laser-Lok 3.0 Implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or 3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading. | | Design | Image: RBM | Image: SLA | Image: Implant | | Material | Non-Cutting Edge Ti-6Al-4V Eli | Cutting Edge Ti-6Al-4V Eli | Non-Cutting Edge Ti-6Al-4V Eli | | Connection | Internal Hex Non - Submerged | Internal Hex | Internal Hex | | Endosseous Implant | Tapered, macro threads | Tapered, macro threads | Tapered, macro threads | | Platform Diameters | $Ø$ 4.0 | - | - | | Fixture Diameters | $Ø$ 3.0, $Ø$ 3.5 | $Ø$ 3.0, $Ø$ 3.3 | $Ø$ 3.0 | | Implantable Lengths | 11.0, 13.0, 15.0 mm | 10.0, 12.0, 14.0 mm | 10.5, 12.0, 15.0 mm | | Modified Surface | R.B.M & S.L.A | S.L.A | R.B.M | {7}------------------------------------------------ | Surgical Technique | 1 and 2 stage, self-tapping | 1 and 2 stage, self-tapping | 1 and 2 stage, self-tapping | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------| | Gamma Sterilization | Yes | Yes | Yes | | SE Discussion | The Magicore Narrow System has similar device characteristics with the Primary predicate such as Indications for use, functions, material, surface treatment (SLA), fixture diameter, surgical technique, sterilization method, structure and applied production method. The difference between the subject device and primary predicate are device design, the longest implantable length and surface treatment (RBM) of the device. To support the Ø3.0 X15mm and the Ø3.5 X15mm long length and surface treatment (RBM), K093321 was added as reference device. Any differences do not raise different questions of safety and effectiveness than the primary predicate; therefore, it is substantial equivalent. | | | Abutment <Closing Screw> | | Subject Device | Reference Device | |-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------| | Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | | Device Name | Magicore Narrow System | Magicore System | | Abutment Name | Closing Screw | Closing Screw | | 510(k) No. | K220079 | K152520 | | Material | TI-6AL-4V ELI | TI-6AL-4V ELI | | Design | Image: Subject Device Design | Image: Reference Device Design | | Diameters (Ø) | 2.75 | 3.5 | | Total Length (mm) | 5.2 | 5.65 | | Surface Treatment | Anodizing (Light Green) | Machined & Anodizing (Yellow, Purple, Blue, Green) | | Sterilization | Gamma Sterilization | Gamma Sterilization | | SE Discussion | The subject device is similar in intended use, fundamental scientific technology, principle of operation, general design, technology, functions, material, anodizing with the cover screw cleared in K152520. The difference between the subject and reference device is dimension of the device. However, it does not affect device's fundamental functions and safety; therefore, it is substantial equivalent. | | #### < Short Abutment ( Hex, Non-Hex)> | | Subject Device | Reference Device | |---------------|------------------------------|------------------------------| | Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | | Device Name | Magicore Narrow System | Magicore II System | | Abutment Name | Short Abutment | Short Abutment | | 510(k) No. | K220079 | K192197 | | Material | TI-6AL-4V ELI | TI-6AL-4V ELI | | Design | Image: Hex Image: Non-Hex | Image: Hex Image: Non-Hex | {8}------------------------------------------------ | Diameters (ø) | 2.8 | 3.5, 3.86, 4.3, 4.6 | |-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Total Length (mm) | 4.2, 5.2, 6.2, 7.2, 8.2 | 4.55, 5.55, 6.55, 7.55, 8.55 | | Surface Treatment | Machine- | Machine- | | Sterilization | End User Sterilization | End User Sterilization | | SE Discussion | The subject device is similar in intended use, fundamental scientific technology, principle of operation, design, technology, functions, dimensions, and materials with the identified reference device. The difference between the subject and reference device is the dimensions of the device. However, it does not affect device's fundamental functions and safety; therefore, it is substantial equivalent. | | # < Magic Abutment (Hex, Non-Hex)> | | Subject Device | Reference Device | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------| | Company | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | | Device Name | Magicore Narrow System | Magicore II System | | Abutment Name | Magic Abutment | Magic Abutment | | 510(k) | K220079 | K192197 | | Material | TI-6AL-4V ELI | TI-6AL-4V ELI | | Design | Image: Hex Image: Non-Hex | Image: Hex Image: Non-Hex | | Diameters (∅) | 3.87 | 4.57, 4.7, 5.07, 5.57, 5.7, 5.87, 6.2, 6.37, 6.5, 7.0 | | Total Lengths(mm) | 4.2, 5.2, 6.2, 7.2, 8.2 | 4.27, 5.21, 5.5, 6.0 | | Surface Treatment | Machine- | Machine- | | Sterilization | End User Sterilization | End User Sterilization | | SE Discussion | The subject device is similar in intended use, fundamental scientific technology, principle of operation, design, technology, functions, dimensions, and materials with the identified reference device. The difference between the subject and reference device is the dimensions of the device. However, it does not affect device's fundamental functions and safety; therefore, it is substantial equivalent. SMAH5506AS | | | | Subject Device | Reference Device | |-------------------|------------------------------|-----------------------------------------------------------| | Company | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | | Device Name | Magicore Narrow System | Magicore System | | Abutment Name | Magic Abutment | Magic Abutment | | 510(k) | K220079 | K212517 | | Material | TI-6AL-4V ELI | TI-6AL-4V ELI | | Design | Image: Hex Image: Non-Hex | Image: Hex Image: Non-Hex | | Diameters (Ø) | 4.5 | 5.2, 5.7, 6.2, 6.7 | | Total Lengths(mm) | 4.2, 5.2, 6.2, 7.2, 8.2 | 4.51, 5.51, 6.5, 6.51, 7.5, 7.51, 8.5, 8.51, 9.5, 10.5 | | Surface Treatment | Machine- | Machine- | | Sterilization | End User Sterilization | End User Sterilization | {9}------------------------------------------------ | SE Discussion | The subject device is similar in intended use, fundamental scientific technology, principle of operation, design, technology, functions, dimensions, and materials | |---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | with the identified reference device. | | | The difference between the subject and reference device is the dimensions of the | | | device. However, it does not affect device's fundamental functions and safety; | | | therefore, it is substantial equivalent. | < Magicore Solid Abutment> | | Subject Device | Reference Device | |-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | | Device Name | Magicore Narrow System | Magicore System | | Abutment Name | Magicore Solid Abutment | Magicore Solid Abutment | | 510(k) No. | K220079 | K201981 | | Material | TI-6AL-4V ELI | TI-6AL-4V ELI | | Design | Image: Design of subject device | Image: Design of reference device | | Diameters (Ø) | 2.8 | 3.5, 3.86, 4.3, 4.6 | | Total Length (mm) | 7.2, 8.2, 9.2, 10.2, 11.2 | 7.6, 8.6, 9.6, 10.6, 11.6 | | Surface Treatment | Machine- | Machine- | | Sterilization | End User Sterilization | End User Sterilization | | SE Discussion | The subject device is similar in intended use, fundamental scientific technology, principle of operation, design, technology, functions, dimensions, and materials with the identified reference device. The difference between the subject and reference device is the dimensions of the device. However, it does not affect device's fundamental functions and safety; therefore, it is substantial equivalent. | | ### <Magicore Solid Abutment Cap> | | Subject Device | Reference Device | |-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | | Device Name | Magicore Narrow System | Magicore System | | Abutment Name | Magicore Solid Abutment Cap | Magicore Solid Abutment Cap | | 510(k) No. | K220079 | K201981 | | Material | PolyOxyMethylene (=Acetal) | PolyOxyMethylene (=Acetal) | | Design | Image: Subject Device Design | Image: Reference Device Design | | Diameters (Ø) | 4.5 | 5.5, 6.0, 6.5, 7.0 | | Total Length (mm) | 5.5, 6.5, 7.5, 8.5, 9.5 | 5.5, 6.5, 7.5, 8.5, 9.5 | | Sterilization | End User Sterilization | End User Sterilization | | SE Discussion | The subject device is similar in intended use, fundamental scientific technology, principle of operation, design, technology, functions, dimensions, and materials with the identified reference device. The difference between the subject and reference device is the dimensions of the device. However, it does not affect device's fundamental functions and safety; therefore, it is substantial equivalent. | | {10}------------------------------------------------ | | Subject Device | Reference Device | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------| | Company | InnoBioSurg Co., Ltd.…

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