CORE1 Implant System

K210039 · Cybermed, Inc. · DZE · Jan 7, 2022 · Dental

Device Facts

Record IDK210039
Device NameCORE1 Implant System
ApplicantCybermed, Inc.
Product CodeDZE · Dental
Decision DateJan 7, 2022
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

CORE1 Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading. CORE1 Implant System 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

Device Story

CORE1 Implant System consists of endosseous dental implants (fixtures) and various prosthetic abutments. Fixtures are placed into alveolar bone to replace missing teeth; they feature internal hex connections and SLA (sandblasted, large-grit, acid-etched) surface treatment. Abutments connect the fixture to the final crown or bridge. The system is used by dental professionals in clinical settings for one or two-stage surgical procedures. The device provides a stable foundation for prosthetic restorations, restoring patient chewing function and aesthetics. The system includes various components like solid, cement, angled, and milling abutments, along with healing caps and screws. The device is intended for delayed loading. Clinical benefit is the restoration of oral function and appearance in edentulous patients.

Clinical Evidence

Bench testing only. Testing included bacterial endotoxin analysis (USP <85>/<161>), fatigue testing (ISO 14801:2016), surface analysis (SEM/EDS), and biocompatibility testing (ISO 10993-1, ISO 10993-5). Sterilization validation performed for gamma (ISO 11137) and steam (ISO 17665). Results confirmed substantial equivalence to predicate devices.

Technological Characteristics

Fixtures: CP Titanium Grade 4 (ASTM F67). Abutments/Screws: Ti-6Al-4V ELI (ASTM F136). Surface: SLA (Sandblasted, Large-grit, Acid-etched). Connection: Internal Hex. Sterilization: Gamma (fixtures) or end-user steam (abutments). Form factor: Bone-level, thread-type implants with various diameters/lengths. No software/algorithm.

Indications for Use

Indicated for partially or fully edentulous patients (mandible/maxilla) requiring single or multiple unit restorations (cemented/screw-retained) or fixed bridgework support. 3.3mm diameter implants indicated for single tooth replacement of mandibular central/lateral incisors and maxillary lateral incisors. Dedicated for one or two-stage surgery; intended for delayed loading.

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

Reference Devices

Related Devices

Submission Summary (Full Text)

{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 seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". Cybermed Inc. Cheol Young Kim President 6-26. Yuseong-daero 1205 beon-gil Yuseong-gu. Daeieon 34104 REPUBLIC OF KOREA Re: K210039 Trade/Device Name: CORE1 Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 29, 2021 Received: December 6, 2021 Dear Cheol Young Kim: 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. 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 {1}------------------------------------------------ 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, 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210039 Device Name CORE1 Implant system Indications for Use (Describe) CORE 1 Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading. CORE 1 Implant System 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------|---------------------------------------------------------------| | <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for CyberEd. The logo is in blue and green. The word "CYBER" is in blue, and the word "ED" is in green. There is a blue checkmark-like symbol between the two words. ## 510(k) Summary Date: January 7, 2022 ### I. SUBMITTER Cybermed Inc. 6-26, Yuseong-daero 1205 beon-gil, Yuseong -gu, Daejeon, 34104, Republic of Korea Tel: +82-42-716-3070 Fax: +82-42-716-3075 Contact Name: Cheol Young Kim Email: kaster@cybermed.co.kr ## II. DEVICE INFORMATION ·Device's Trade name: CORE1 Implant System ·Classification Name: implant, endosseous, root-form ·Device's Common Name: Endosseous dental implant ·Regulation Number 872.3640 ·Class: 2 ·Primary Product Code: DZE ·Secondary Product Code: NHA ## III. PREDICATE DEVICE Primary predicate device K153639, OneQ-SL s-Clean Implant System, Dentis Co., Ltd. Reference device K161244, s-Clean OneQ-SL Narrow Implant System, Dentis Co., Ltd. K190837, Internal Hex Implant System, EBI Inc. K123988, Xpeed AnyRidge Internal Implant System, MegaGen Implant Co., Ltd K172100, URIS OMNI System, Tru Abutment Inc. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Cyber 1ED. The word "CYBER" is in blue, and the "1ED" is in green. The "1" in "1ED" is shaped like a check mark. K161689, OSSTEM Implant System – Abutment, OSSTEM Implant Co., Ltd. K140507, Hiossen Prosthetic System, OSSTEM Implant Co., Ltd. K173570, SD Abutment, Surgident Co., Ltd. K173141, CSM Submerged3-L Implant System, CSM Implant K181138, IS-III active System, Neobiotech. Co., Ltd. K072642, BIOMET 3i Dental Abutments & Restorative Components, BIOMET 3i, Inc. K153521, IH Implant System, Sewon Medix Inc. K120847, ET/SS Implant System, OSSTEM Implant Co., Ltd. ## IV. DEVICE DESCRIPTION ### 1) CORE1 Fixture CORE1 Fixture is a thread type implant made of CP Titanium Gr.4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic device or other components of a dental implant set with human body (mandibular or maxillary bone). Fixtures are provided after gamma sterilization as a set package including a cover screw or as a single fixture. ## 2) CORE1 Abutment - CORE1 Abutment intended for Single Unit restorations is a superstructure of a । dental implant system and connecting elements between the dental implant and the crown. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows single prosthetic restorations to restore a patient's chewing function. Abutment Screw made of Ti-6AI-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Solid Abutment, Cement Abutment, Angled Abutment, Milling Abutment, Temporary Abutment, Solid Protect Cap, Cover Screw, Healing Abutment, Healing Abutment (Scan). Angled Abutment can select 15° and 25° angles for prosthetics, and Milling Abutment is up to 20° for hand milling only. {5}------------------------------------------------ - CORE1 Abutment intended for Multi-Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the bridge. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows multi prosthetic restorations to restore a patient's chewing function. Universal Plastic Cylinder is a burn-out device only used in the lab for casting and is not part of the final restoration. Abutment Screw made of Ti-6A1-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Universal Abutment, Universal Angled Abutment, Universal Ti Cylinder, Universal Temporary Cylinder, Universal Healing Cap. Universal Angled Abutment has angles of 17%30°. #### V. INDICATION FOR USE CORE1 Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading. CORE1 Implant System 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. {6}------------------------------------------------ ## VI. COMPARISON OF TECHNILOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE #### Table 1 : Substantial Equivalence – Indication for Use Statements | | Subject device | Predicate device | Reference device | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | EQUIVALENCE<br>DISCUSSION | K210039<br>COE1 Implant System<br>Cybermed Inc. | K153639<br>OneQ-SL s-Clean Implant System<br>DENTIS CO., LTD. | K161244<br>s-Clean OneQ-SL Narrow Implant System<br>Dentis Co., Ltd. | | Indications for<br>Use Statement | CORE1 Implant System is indicated for use in<br>partially or fully edentulous mandibles and<br>maxillae, in support of single or multiple unit<br>restorations including; cemented retained, screw<br>retained, and terminal or intermediate abutment<br>support for fixed bridgework. This system is<br>dedicated for one and two stage surgical<br>procedures. This system is intended for delayed<br>loading.<br><br>CORE1 Implant System 3.3mm diameter<br>implants may be used as an artificial root<br>structure for single tooth replacement of | The OneQ-SL s-Clean Implant System is<br>indicated for use in partially or fully edentulous<br>mandibles and maxillae, in support of single or<br>multiple unit restorations including; Cemented<br>retained, screw retained, or overdenture<br>restorations, and terminal or intermediate<br>abutment support for fixed bridgework. This<br>system is dedicated for one and two stage surgical<br>procedures. This system is intended for delayed<br>loading. | The s-Clean OneQ-SL Narrow Implant System<br>(3.0, 3.3mm) may be used as an artificial root<br>structure for single tooth replacement of<br>mandibular central and lateral incisors and<br>maxillary lateral incisors. The implants may be<br>restored immediately 1) with a temporary<br>prosthesis that is not in functional occlusion, 2)<br>when splinted together as an artificial root<br>structure for multiple tooth replacement of<br>mandibular incisors, or 3) for denture stabilization<br>using multiple implants in the anterior mandible<br>and maxilla. The implants may be placed in<br>immediate function when good primary stability | {7}------------------------------------------------ | mandibular central and lateral incisors and<br>maxillary lateral incisors. | has been achieved and with appropriate occlu<br>loading. | |----------------------------------------------------------------------------|----------------------------------------------------------| |----------------------------------------------------------------------------|----------------------------------------------------------| This language is identical and substantially equivalent to the identified primary predicate, OneQ-SL s-Clean Implant System, Dentis Co., Ld. K153639. To support the smaller platform diameter 0 3.3mm, s-Clean OneQ-SL Narrow Implant System K161244 was added as reference device. The differences in language with reference K161244 related to immediate loading does not apply to the Corel Implant System, as the Core1 Implant System is intended only for delayed loading. ## Table 2 : Substantial Equivalence EQUIVALENCE DISCUSSION – Technological characteristics – Implant | | Subject Device | Predicate Device | Reference Device | Reference Device | Reference Device | EQUIVALENCE<br>DISCUSSION | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Part<br>Name | CORE1 Fixture | OneQ-SL s-Clean Fixture | s-Clean OneQ-SL Narrow<br>Implant | BLT II OS Implant | XPEED AnyRidge<br>Internal Fixture | | | Trade<br>Name | CORE1 Implant System | OneQ-SL s-Clean Implant<br>System | s-Clean OneQ-SL Narrow<br>Implant System | Internal Hex Implant<br>System | XPEED AnyRidge<br>Internal Implant System | | | Manufact<br>urer | Cybermed Inc. | DENTIS CO., LTD. | Dentis Co., Ltd. | EBI Inc. | MegaGen Implant Co.,<br>Ltd | | | 510(k)<br>Number | K210039 | K153639 | K161244 | K190837 | K123988 | | | Material | CP Ti Grade 4<br>(ASTM F67) | CP Ti Grade 4<br>(ASTM F67) | Ti-6Al-4V ELI<br>(ASTM F136) | CP Ti Grade 4<br>(ASTM F67) | CP Ti Grade 4 (ASTM<br>F67) | Equivalent<br>Compared to the predicate<br>and reference device, the | | | | | | | | subject device's raw<br>material is same as<br>predicate device. | | Surface<br>treatment | SLA | SLA | SLA | SLA | SLA | Same | | Connecti<br>on type | Internal Hex | Internal Hex | Internal Hex | Internal Hex | Internal Hex | Same | | Diameter<br>(Ø)<br>&<br>Total<br>Length<br>(mm) | Ø 3.3 x 8.5, 10.0, 11.5,<br>13.0mm<br>Ø 3.6 x 8.5, 10.0, 11.5, 13.0<br>mm<br>Ø 3.8 x 8.5, 10.0, 11.5, 13.0<br>mm<br>Ø 3.82 x 8.5, 10.0, 11.5, 13.0<br>mm<br>Ø 4.1 x 7.0, 8.5, 10.0, 11.5,<br>13.0 mm<br>Ø 4.2 x 7.0, 8.5, 10.0, 11.5,<br>13.0 mm<br>Ø 4.35 x 7.0, 8.5, 10.0, 11.5,<br>13.0 mm<br>Ø 4.6 x 7.0, 8.5, 10.0, 11.5,<br>13.0 mm<br>Ø 4.65 x 7.0, 8.5, 10.0, 11.5,<br>13.0 mm<br>Ø 4.97 x 7.0, 8.5, 10.0, 11.5,<br>13.0 mm | Ø 3.5 x 7.0, 8.0, 10.0, 12.0,<br>14.0mm<br>Ø 3.6 x 7.0, 8.0, 10.0, 12.0,<br>14.0mm<br>Ø 3.7 x 7.0, 8.0, 10.0, 12.0,<br>14.0mm<br>Ø 4.2 x 7.0, 8.0, 10.0, 12.0,<br>14.0mm<br>Ø 4.7 x 7.0, 8.0, 10.0, 12.0,<br>14.0mm<br>Ø 5.8 x 7.0, 8.0, 10.0, 12.0mm<br>Ø 6.8 x 7.0, 8.0, 10.0, 12.0mm | Ø 3.0 x 10.0, 12.0, 14.0mm<br>Ø 3.3 x 10.0, 12.0, 14.0mm | Ø 3.25-5.5 x 7-18mm | Ø 3.9 x 7.0, 8.0, 9.5, 11.0,<br>12.5, 14.5 mm<br>Ø 4.3 x 7.0, 8.0, 9.5, 11.0,<br>12.5, 14.5 mm<br>Ø 4.8 x 7.0, 8.0, 9.5, 11.0,<br>12.5, 14.5 mm<br>Ø 5.3 x 7.0, 8.0, 9.5, 11.0,<br>12.5, 14.5 mm<br>Ø 5.8 x 7.0, 8.0, 9.5, 11.0,<br>12.5, 14.5 mm<br>Ø 6.3 x 7.0, 8.0, 9.5, 11.0,<br>12.5, 14.5 mm<br>Ø 6.8 x 7.0, 8.0, 9.5, 11.0,<br>12.5, 14.5 mm<br>Ø 7.3 x 7.0, 8.0, 9.5, 11.0,<br>12.5, 14.5 mm<br>Ø 7.8 x 7.0, 8.0, 9.5, 11.0,<br>12.5, 14.5 mm<br>Ø 8.3 x 7.0, 8.0, 9.5, 11.0,<br>12.5, 14.5 mm | Equivalent<br>The combined diameter<br>and total length of subject<br>device is slightly different<br>with predicate and<br>reference device, but all<br>the subject combination of<br>diameter and length is<br>within the range of<br>dimension.<br>Subject device verified<br>through performance test,<br>so this difference of range<br>doesn't impact substantial<br>equivalence. | | Sterilizati<br>on | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterile | Gamma Sterilization | Same | | Implant<br>Type | Bone Level | Bone Level | Bone Level | Bone Level | Bone Level | Same | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Cyber1ED. The logo consists of the word "CYBER" in blue, followed by a stylized number "1" in blue and green, and the letters "ED" in green. The stylized number "1" has a curved shape at the top, resembling a check mark. {9}------------------------------------------------ #### Table 3 : Substantial Equivalence EQUIVALENCE DISCUSSION – Technological characteristics – Abutment | | Subject Device | Predicate Device | EQUIVALENCE DISCUSSION | |---------------------|-------------------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Part Name | Solid Abutment | D Basis Abutment -Direct Type | - | | Trade Name | CORE1 Implant System | URIS OMNI System | - | | Manufacturer | Cybermed Inc. | Tru Abutment Korea Co., Ltd. | - | | 510(k) Number | K210039 | K172100 | - | | Usage | It is one body cement retained restoration | It is one body cement retained restoration. | - | | Type of restoration | Single unit | | - | | Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Same | | Surface treatment | Machined Type | Machined Type | Same | | Diameter (Ø) | 4.0/4.6/5.0/6.0 | 4.0/4.5/5.5/6.5 | Equivalent<br>The subject device diameters are in the range of<br>diameters of the predicate device. Subject<br>device was verified through performance test, so<br>this difference of range doesn't impact<br>substantial equivalence. | | Length (mm) | G/H : 1.0/2.0/3.0/4.0/5.0<br>Post : 4.0/5.5/7.0 | G/H :1.0/2.0/3.0/4.0/5.0/6.0<br>Post : 4.0/5.5/7.0 | Equivalent<br>The subject device lengths are in the range of<br>diameters of the predicate device. Subject<br>device was verified through performance test, so | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for CyberEd. The logo is made up of the word "CYBER" in blue, followed by a blue tooth-shaped icon with a green number "1" inside of it. The word "ED" is written in green to the right of the tooth icon. | | | | this difference of range doesn't impact<br>substantial equivalence | |---------------|------------------------|------------------------|--------------------------------------------------------------------| | Sterilization | End User Sterilization | End User Sterilization | Same | | | Subject Device | Predicate Device | EQUIVALENCE DISCUSSION | |---------------------|-----------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Part name | Cement Abutment | Best Duo Abutment | - | | Trade Name | CORE1 Implant System | Internal Hex Implant System | - | | Manufacturer | Cybermed Inc. | EBI Inc. | - | | 510(k) Number | K210039 | K190837 | - | | Usage | Using making for general cement-type<br>prosthesis. | Using making for general cement-type<br>prosthesis. | - | | Type of restoration | Single unit | | | | Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Same | | Surface treatment | Machined Type | Machined Type | Same | | Diameter (Ø) | 4.0/4.6/5.0/6.0 | 3.5, 4.0, 4.8, 5.5, 6.5 | Equivalent<br>The subject device diameters are in the range of<br>diameters of the predicate device. Subject<br>device was verified through performance test, so<br>this difference of range doesn't impact<br>substantial equivalence. | | Length (mm) | Post : 4.0/5.5/7.0 | Post : 5.2, 7.2 | Equivalent | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo and address of Cybermed Inc. The logo is on the left side of the image and consists of the letters "MED" in green and blue. The address is on the right side of the image and reads "6-26, Yuseong-daero 1205 beon-gil, Yuseong -gu, Daejeon, 34104, Republic of Korea". CY The subject device lengths are in the range of diameters of the predicate device. Subject device was verified through performance test, so this difference of range doesn't impact substantial equivalence | Sterilization | Same | |------------------------|------------------------| | End User Sterilization | End User Sterilization | | | Subject Device | Predicate Device | EQUIVALENCE DISCUSSION | |-------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Part Name | Cement Abutment Screw | Abutment Screw | | | Trade Name | CORE1 Implant System | OSSTEM Implant System - Abutment | | | Manufacture | Cybermed Inc. | OSSTEM Implant Co., Ltd. | | | 510(k) Number | K210039 | K161689 | | | Usage | It is used to connect and fix the abutment to<br>the fixture tightly. | It is used to connect and fix the abutment to<br>the fixture tightly. | | | Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Same | | Surface treatment | Machined Type | Machined Type | Same | | Diameter | 2.2/2.3 | 2.0/2.05/2.2/2.3/2.5 | Equivalent<br>The subject device diameters are in the range of<br>predicate device's diameters. | | Length (mm) | 8.35/10.2 | 3.35/5.6/7.5/8.35/9.6/10.2 | Equivalent<br>The subject device lengths are in the range of<br>diameters of the predicate device. Subject | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo and address of Cybermed Inc. The logo is a stylized text with the word "CYBER" in blue and "1ED" in green. The address is "6-26, Yuseong-daero 1205 beon-gil, Yuseong -gu, Daejeon, 34104, Republic of Korea". | Sterilization | End User Sterilization | End User Sterilization | device was verified through performance test, so<br>this difference of range doesn't impact<br>substantial equivalence | |---------------|------------------------|------------------------|------------------------------------------------------------------------------------------------------------------------| | | | | Same | | | Subject Device | Predicate Device | EQUIVALENCE DISCUSSION | |---------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Part Name | Angled Abutment | Best Angled Abutment | | | Trade Name | CORE1 Implant System | Internal Hex Implant System | | | Manufacturer | Cybermed Inc. | EBI Inc. | | | 510(k) Number | K210039 | K190837 | | | Usage | It is used when a prosthetic's path adjustment<br>is necessary. | It is used when a prosthetic's path adjustment is<br>necessary. | | | Type of restoration | Single unit | | | | Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Same | | Surface treatment | Machined Type | Machined Type | Same | | Diameter (Ø) | 4.0/4.6/5.0/5.5/6.0 | 3.5/4.0/4.8 | Equivalent<br>Subject device diameters are within the range of<br>diameters of the predicate and reference devices<br>or larger. Larger diameters do not represent a<br>worst case in terms of performance. | | Angle (°) | 15/25 | 15/25 | Same | {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for Cyber 1 ED. The word "CYBER" is in blue, followed by a blue tooth-shaped icon. The number "1" and the letters "ED" are in green. The logo is simple and modern, and the colors are bright and eye-catching. | Sterilization | End User Sterilization | End User Sterilization | Same | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Reference Device | EQUIVALENCE DISCUSSION | | Part name | Milling Abutment | Free Form Abutment | - | | Trade Name | CORE1 Implant System | Hiossen Prosthetic System | - | | Manufacturer | Cybermed Inc. | OSSTEM Implant co., Ltd. | - | | 510(k) Number | K210039 | K140507 | - | | Usage | This product is used for marking a final<br>artificial tooth to provide masticatory and<br>aesthetic function and only to hand milled. | This product is used for marking a final artificial<br>tooth to provide masticatory and aesthetic<br>function and only to hand milled. | - | | Type of restoration | Single unit | Single unit | - | | Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Same | | Surface treatment | Machined Type | TiN Coating | Different<br>Compared to the predicate device, the subject<br>device's surface treatment is different. This<br>difference of range doesn't impact substantial<br>equivalence. | | Diameter (Ø) | 4.0/4.6/5.0/5.5/6.0 | 4.0/5.5/7.0 | Equivalent<br>The subject device diameters are in the range of<br>diameters of the predicate device. Subject device<br>was verified through performance test, so this<br>difference of range doesn't impact substantial<br>equivalence. | | Length (mm) | G/H : 1.0/2.0/3.0/4.0/5.0 | G/H : 0.5/1.0/1.5/2.0/2.5/3.0/4.0/5.0 | Equivalent<br>Subject devices are within the range of predicate<br>devices diameters | | Sterilization | End User Sterilization | End User Sterilization | Same | | Final design parameters<br>for hand milling | Post Length : 5.0 to 9.0<br>Total Length : 6.1 to 10.1<br>Wall thickness : Min 0.4 to Max 1.3<br>Angulation : Min 0° to 20°<br>Gingival height : 1.0 to 5.0 | | | {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for Cyber 1 ED. The word "CYBER" is in blue, and the "1ED" is in green. There is a blue tooth-shaped icon between the two words. | | Subject Device | Predicate Device | Reference Device | EQUIVALENCE DISCUSSION | |---------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------| | Part Name | Temporary Abutment | Temporary Abutment | Temporary Abutment | - | | Trade Name | CORE1 Implant System | SD Abutment | CSM Submerged3-L Implant<br>System | - | | Manufacturer | Cybermed Inc. | Surgident Co., Ltd. | CSM Implant | - | | 510(k) Number | K210039 | K173570 | K173141 | - | | Usage | It is used temporarily to maintain<br>esthetic appearance until final<br>prosthesis is made. | It is used temporarily to maintain<br>esthetic appearance until final<br>prosthesis is made. | It is used temporarily to maintain<br>esthetic appearance until final<br>prosthesis is made. | - | | Type of restoration | Single Unit | | | | | Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6AI-4V ELI (ASTM F136), or<br>CP Ti Grade 4 (ASTM F67) | Ti-6Al-4V ELI (ASTM-F136) | Same | | Surface treatment | Machined type | Machined type | Machined type | Same | {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the logo for CyberEd. The logo is made up of the word "CYBER" in blue, followed by a blue tooth-shaped icon. The word "ED" is in green. The logo is simple and modern, and it is likely used to represent a company or organization that is involved in cybersecurity education. | Diameter (Ø) | 4.0/4.6/5.0/5.5/6.0 | 4.0/4.5/5.0/5.5/6.0/6.5 | | Equivalent<br>The subject device diameters are in<br>the range of diameters of the<br>predicate device. Subject device<br>was verified through performance<br>test, so this difference of range<br>doesn't impact substantial<br>equivalence. | |---------------|--------------------------|-------------------------|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Length (mm) | 12.8/13.8/14.8/15.8/16.8 | | 12.8/13.3/13.8/14.8/15.8/16.8 | Same | | Sterilization | End User Sterilization | End User Sterilization | End User Sterilization | Same | | | Subject Device | Predicate Device | Reference Device | EQUIVALENCE DISCUSSION | |---------------|-------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Part Name | Solid Protect Cap | Rigid Protect Cap | Rigid Retraction Cap | | | Trade Name | CORE1 Implant System | OSSTEM Implant System -<br>Abutment | OSSTEM Implant System -<br>Abutment | | | Manufacturer | Cybermed Inc. | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. | | | 510(k) Number | K210039 | K161689 | K161689 | | | Usage | It is used to protect Solid Abutment<br>in the oral cavity. | Used for the protection of the | Used for the protection of the<br>Rigid Abutment in the oral cavity. | | | Material | POM(Polyoxymethylene) | PC(Poly Carbonate Polymer) | POM(Polyoxymethylene) | Different<br>Compared to the predicate device,<br>the subject device's raw material is<br>different. However,<br>POM(Polyoxymethylene) and | {16}------------------------------------------------ Image /page/16/Picture/0 description: The image shows the logo for Cyber1ED. The logo is in blue and green. The word "CYBER" is in blue, and the "1ED" is in green. The number "1" is shaped like a tooth. The text next to the logo says "Cyber" and "6-26, Korea". | | | | | PC(Poly Carbonate Polymer) are<br>widely used as medical device<br>material and have proven safe, so<br>these differences do not affect<br>safety and performance. | |---------------|------------------------|---------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Diameter (Ø) | 4.5/5.1/5.5/6.5 | 4.4/5.0/5.5/6.6/7.4 | 4.8/6.0/6.6/7.7/8.7 | Equivalent<br>The subject device diameters are in<br>the range of diameters of the<br>predicate device. Subject device<br>was verified through performance<br>test, so this difference of range<br>doesn't impact substantial<br>equivalence. | | Length (mm) | 5.5/7.0/8.5 | 5.5/5.7/5.8/5.9/7.0/7.2/7.3/8.5/<br>8.7/8.8 | 5.5/7.0/8.5 | Equivalent<br>Subject devices are within the range<br>of predicate devices diameters. | | Sterilization | End User Sterilization | End User Sterilization | End User Sterilization | Same | | | Subject Device…
Innolitics
510(k) Summary
Decision Summary
Classification Order
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