(366 days)
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, 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.
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.
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.
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°.
The provided document is a 510(k) summary for the CORE1 Implant System, demonstrating its substantial equivalence to predicate devices. It focuses on physical and material characteristics and performance testing based on industry standards, rather than clinical study results involving human or expert evaluation for diagnostic accuracy.
Therefore, many of the requested details, such as those related to "acceptance criteria" for diagnostic accuracy, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details" are not applicable or extractable from this document as it pertains to a dental implant system, not an AI/diagnostic device.
However, I can extract information related to the device's performance through non-clinical testing.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
The document doesn't define specific numerical "acceptance criteria" in a table format for diagnostic performance, as it's a dental implant. Instead, it describes performance through non-clinical testing against established ISO standards and FDA guidance for dental implants. The "acceptance" is demonstrated by meeting the requirements of these standards.
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Endotoxin Test | According to USP <85><161> and ANSI/AAMI ST72:2011. Testing limit of 20 EU/device for blood contacting and implanted device. | Confirmed that the endotoxin test reagent (PTS cartridge) and laboratory environment were suitable, meeting endotoxin standards and established criteria. Implies performance within the accepted limit. |
| Fatigue Testing | According to ISO 14801:2016 and FDA guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". Objective: Confirm permanent restoration of the implant without failure. | Performed on the subject device and reference device K190837 to confirm covering permanent restoration of the implant without failure. The language "to confirm covering permanent restoration of the implant without failure" implies successful completion meeting the standard. |
| Surface Analysis | Not explicitly stated as a separate acceptance criterion but is part of material characterization. | SEM & EDS analysis showed surface roughness leading to a macroroughness and no other impurity on the surface of the final product. This indicates the desired surface characteristics were achieved. |
| Gamma Sterilization | According to ISO 11137-1:2006/Amd.1:2013, ISO 11137-2:2013, and ISO 11137-3:2006. Objective: Acceptable range of densities of other product in carrier and confirm process stability. | Evaluation showed an acceptable range of densities of other products in the carrier and confirmed process stability. Concluded that the packaging with gamma sterilization of the subject device is equivalent to predicate/reference devices, with a shelf life of 5 years. |
| End User Sterilization | According to ISO 17665-1:2006, ISO 17665-2:2009, and ANSI/AAMI ST79:2010/A4:2013. | Performed according to the stated standards. The implicit result is that it meets the requirements for end-user sterilization. |
| Biocompatibility Testing | According to ISO 10993-1:2018 and FDA Guidance Document "Use of International Standard ISO 10993-1...", and ISO 10993-5:2009. | Performed for each subject device. The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate devices, which includes assurance of biocompatibility. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a number of devices. The testing is based on performing the required tests as per relevant ISO standards. For fatigue testing, it states it was performed on "subject device and reference device K190837," implying at least one of each for the test, but typically these tests involve multiple samples to establish robustness and statistical significance as required by the standards.
- Data provenance: Not specified in terms of country of origin or whether it was retrospective/prospective. As this is non-clinical bench testing, the data is generated in a laboratory setting. The manufacturer, Cybermed Inc., is from the Republic of Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. This device is a dental implant, not a diagnostic device requiring expert review for "ground truth" establishment of medical conditions. The "ground truth" for performance is based on established engineering and materials science standards for dental implants.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is non-clinical bench testing against established standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a dental implant, not an AI/diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a dental implant, not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is derived from compliance with international and national standards for medical device safety and performance, specifically for dental implants (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility, ISO 11137 for sterilization, USP <85><161> for endotoxins).
8. The sample size for the training set:
Not applicable. This document does not describe a machine learning or AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set."
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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
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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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
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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.
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- 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.
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VI. COMPARISON OF TECHNILOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Table 1 : Substantial Equivalence – Indication for Use Statements
| Subject device | Predicate device | Reference device | |
|---|---|---|---|
| EQUIVALENCEDISCUSSION | K210039COE1 Implant SystemCybermed Inc. | K153639OneQ-SL s-Clean Implant SystemDENTIS CO., LTD. | K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. |
| Indications forUse Statement | CORE1 Implant System is indicated for use inpartially or fully edentulous mandibles andmaxillae, in support of single or multiple unitrestorations including; cemented retained, screwretained, and terminal or intermediate abutmentsupport for fixed bridgework. This system isdedicated for one and two stage surgicalprocedures. This system is intended for delayedloading.CORE1 Implant System 3.3mm diameterimplants may be used as an artificial rootstructure for single tooth replacement of | The OneQ-SL s-Clean Implant System isindicated for use in partially or fully edentulousmandibles and maxillae, in support of single ormultiple unit restorations including; Cementedretained, screw retained, or overdenturerestorations, and terminal or intermediateabutment support for fixed bridgework. Thissystem is dedicated for one and two stage surgicalprocedures. This system is intended for delayedloading. | The s-Clean OneQ-SL Narrow Implant System(3.0, 3.3mm) may be used as an artificial rootstructure for single tooth replacement ofmandibular central and lateral incisors andmaxillary lateral incisors. The implants may berestored immediately 1) with a temporaryprosthesis that is not in functional occlusion, 2)when splinted together as an artificial rootstructure for multiple tooth replacement ofmandibular incisors, or 3) for denture stabilizationusing multiple implants in the anterior mandibleand maxilla. The implants may be placed inimmediate function when good primary stability |
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| mandibular central and lateral incisors andmaxillary lateral incisors. | has been achieved and with appropriate occluloading. |
|---|---|
| ---------------------------------------------------------------------------- | ---------------------------------------------------------- |
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 | EQUIVALENCEDISCUSSION | |
|---|---|---|---|---|---|---|
| PartName | CORE1 Fixture | OneQ-SL s-Clean Fixture | s-Clean OneQ-SL NarrowImplant | BLT II OS Implant | XPEED AnyRidgeInternal Fixture | |
| TradeName | CORE1 Implant System | OneQ-SL s-Clean ImplantSystem | s-Clean OneQ-SL NarrowImplant System | Internal Hex ImplantSystem | XPEED AnyRidgeInternal Implant System | |
| Manufacturer | Cybermed Inc. | DENTIS CO., LTD. | Dentis Co., Ltd. | EBI Inc. | MegaGen Implant Co.,Ltd | |
| 510(k)Number | K210039 | K153639 | K161244 | K190837 | K123988 | |
| Material | CP Ti Grade 4(ASTM F67) | CP Ti Grade 4(ASTM F67) | Ti-6Al-4V ELI(ASTM F136) | CP Ti Grade 4(ASTM F67) | CP Ti Grade 4 (ASTMF67) | EquivalentCompared to the predicateand reference device, the |
| subject device's rawmaterial is same aspredicate device. | ||||||
| Surfacetreatment | SLA | SLA | SLA | SLA | SLA | Same |
| Connection type | Internal Hex | Internal Hex | Internal Hex | Internal Hex | Internal Hex | Same |
| Diameter(Ø)&TotalLength(mm) | Ø 3.3 x 8.5, 10.0, 11.5,13.0mmØ 3.6 x 8.5, 10.0, 11.5, 13.0mmØ 3.8 x 8.5, 10.0, 11.5, 13.0mmØ 3.82 x 8.5, 10.0, 11.5, 13.0mmØ 4.1 x 7.0, 8.5, 10.0, 11.5,13.0 mmØ 4.2 x 7.0, 8.5, 10.0, 11.5,13.0 mmØ 4.35 x 7.0, 8.5, 10.0, 11.5,13.0 mmØ 4.6 x 7.0, 8.5, 10.0, 11.5,13.0 mmØ 4.65 x 7.0, 8.5, 10.0, 11.5,13.0 mmØ 4.97 x 7.0, 8.5, 10.0, 11.5,13.0 mm | Ø 3.5 x 7.0, 8.0, 10.0, 12.0,14.0mmØ 3.6 x 7.0, 8.0, 10.0, 12.0,14.0mmØ 3.7 x 7.0, 8.0, 10.0, 12.0,14.0mmØ 4.2 x 7.0, 8.0, 10.0, 12.0,14.0mmØ 4.7 x 7.0, 8.0, 10.0, 12.0,14.0mmØ 5.8 x 7.0, 8.0, 10.0, 12.0mmØ 6.8 x 7.0, 8.0, 10.0, 12.0mm | Ø 3.0 x 10.0, 12.0, 14.0mmØ 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, 11.0,12.5, 14.5 mmØ 4.3 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ 4.8 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ 5.3 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ 5.8 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ 6.3 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ 6.8 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ 7.3 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ 7.8 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mmØ 8.3 x 7.0, 8.0, 9.5, 11.0,12.5, 14.5 mm | EquivalentThe combined diameterand total length of subjectdevice is slightly differentwith predicate andreference device, but allthe subject combination ofdiameter and length iswithin the range ofdimension.Subject device verifiedthrough performance test,so this difference of rangedoesn't impact substantialequivalence. |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterile | Gamma Sterilization | Same |
| ImplantType | Bone Level | Bone Level | Bone Level | Bone Level | Bone Level | Same |
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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.
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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 | EquivalentThe subject device diameters are in the range ofdiameters of the predicate device. Subjectdevice was verified through performance test, sothis difference of range doesn't impactsubstantial equivalence. |
| Length (mm) | G/H : 1.0/2.0/3.0/4.0/5.0Post : 4.0/5.5/7.0 | G/H :1.0/2.0/3.0/4.0/5.0/6.0Post : 4.0/5.5/7.0 | EquivalentThe subject device lengths are in the range ofdiameters of the predicate device. Subjectdevice was verified through performance test, so |
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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 impactsubstantial 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-typeprosthesis. | Using making for general cement-typeprosthesis. | - |
| 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 | EquivalentThe subject device diameters are in the range ofdiameters of the predicate device. Subjectdevice was verified through performance test, sothis difference of range doesn't impactsubstantial equivalence. |
| Length (mm) | Post : 4.0/5.5/7.0 | Post : 5.2, 7.2 | Equivalent |
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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 tothe fixture tightly. | It is used to connect and fix the abutment tothe 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 | EquivalentThe subject device diameters are in the range ofpredicate device's diameters. |
| Length (mm) | 8.35/10.2 | 3.35/5.6/7.5/8.35/9.6/10.2 | EquivalentThe subject device lengths are in the range ofdiameters 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, sothis difference of range doesn't impactsubstantial 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 adjustmentis necessary. | It is used when a prosthetic's path adjustment isnecessary. | |
| 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 | EquivalentSubject device diameters are within the range ofdiameters of the predicate and reference devicesor larger. Larger diameters do not represent aworst 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 finalartificial tooth to provide masticatory andaesthetic function and only to hand milled. | This product is used for marking a final artificialtooth to provide masticatory and aestheticfunction 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 | DifferentCompared to the predicate device, the subjectdevice's surface treatment is different. Thisdifference of range doesn't impact substantialequivalence. |
| Diameter (Ø) | 4.0/4.6/5.0/5.5/6.0 | 4.0/5.5/7.0 | EquivalentThe subject device diameters are in the range ofdiameters of the predicate device. Subject devicewas verified through performance test, so thisdifference of range doesn't impact substantialequivalence. |
| 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 | EquivalentSubject devices are within the range of predicatedevices diameters |
| Sterilization | End User Sterilization | End User Sterilization | Same |
| Final design parametersfor hand milling | Post Length : 5.0 to 9.0Total Length : 6.1 to 10.1Wall thickness : Min 0.4 to Max 1.3Angulation : Min 0° to 20°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 ImplantSystem | - |
| Manufacturer | Cybermed Inc. | Surgident Co., Ltd. | CSM Implant | - |
| 510(k) Number | K210039 | K173570 | K173141 | - |
| Usage | It is used temporarily to maintainesthetic appearance until finalprosthesis is made. | It is used temporarily to maintainesthetic appearance until finalprosthesis is made. | It is used temporarily to maintainesthetic appearance until finalprosthesis is made. | - |
| Type of restoration | Single Unit | |||
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6AI-4V ELI (ASTM F136), orCP 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 | EquivalentThe subject device diameters are inthe range of diameters of thepredicate device. Subject devicewas verified through performancetest, so this difference of rangedoesn't impact substantialequivalence. | |
|---|---|---|---|---|
| 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 -Abutment | OSSTEM Implant System -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 Abutmentin the oral cavity. | Used for the protection of the | Used for the protection of theRigid Abutment in the oral cavity. | |
| Material | POM(Polyoxymethylene) | PC(Poly Carbonate Polymer) | POM(Polyoxymethylene) | DifferentCompared to the predicate device,the subject device's raw material isdifferent. However,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) arewidely used as medical devicematerial and have proven safe, sothese differences do not affectsafety 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 | EquivalentThe subject device diameters are inthe range of diameters of thepredicate device. Subject devicewas verified through performancetest, so this difference of rangedoesn't impact substantialequivalence. |
| Length (mm) | 5.5/7.0/8.5 | 5.5/5.7/5.8/5.9/7.0/7.2/7.3/8.5/8.7/8.8 | 5.5/7.0/8.5 | EquivalentSubject devices are within the rangeof predicate devices diameters. |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization | Same |
| Subject Device | Predicate device | EQUIVALENCE DISCUSSION | |
|---|---|---|---|
| Part Name | Cover Screw | Cover Screw | |
| Trade Name | CORE1 Implant System | Internal Hex Implant System | |
| Manufacturer | Cybermed Inc. | EBI Inc. | |
| 510(k) Number | K210039 | K190837 | |
| Usage | It is to protect exposed top of the fixture, is to | It is to protect exposed top of the fixture, is to be |
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the logo for Cybermed. The logo consists of the word "CYBER" in blue, followed by a blue tooth shape with the number "1" inside it. The letters "ED" are in green and are placed to the right of the tooth shape.
| be used in a tooth gap after inserting the implant. | used in a tooth gap after inserting the implant. | ||
|---|---|---|---|
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI Alloy | Same |
| Surface treatment | Anodizing | Anodizing | Same |
| Diameter (Ø) | 3.05/3.1/3.25/3.4/3.6 | 3.0, 3.2, 3.6 | EquivalentThe subject device diameters are in the range ofdiameters of the predicate device. Subjectdevice was verified through performance test, sothis difference of range doesn't impactsubstantial equivalence. |
| Length (mm) | G/H : 0.4, 1.25, 2.25 | G/H : 0.4, 1.25, 2.25 | Same |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Same |
| Subject Device | Predicate Device | EQUIVALENCE DISCUSSION | |
|---|---|---|---|
| Part Name | Healing Abutment | IS Healing Abutment | |
| Trade Name | CORE1 Implant System | IS-III active System | |
| Manufacturer | Cybermed Inc. | Neobiotech Co., Ltd | |
| 510(k) Number | K210039 | K181138 | |
| Usage | It is used with fixture to protect the innerconfiguration of the implant and maintain,stabilize and form the soft tissue the healingprocess. | It is used with fixture to protect the innerconfiguration of the implant and maintain,stabilize and form the soft tissue the healingprocess. |
{18}------------------------------------------------
Image /page/18/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.
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI of ASTM F136 | Same |
|---|---|---|---|
| Surface treatment | Machined type | Machined type | Same |
| Diameter ( $ø$ ) | 4.3/4.8/5.3/6.3/7.3/8.3 | 4.0/4.5/4.8/5.5/6.0/6.8/8.0/9.0 | EquivalentThe subject device diameters are in the range ofdiameters of the predicate device. Subjectdevice was verified through performance test, sothis difference of range doesn't impactsubstantial equivalence. |
| Length(mm) | G/H: 3.0/4.0/5.0/7.0/9.0 | G/H: 2.3/2.8/3.3/3.8/4.3/4.8/5.3/5.8/6.3/6.8/7.8 | EquivalentSubject devices are included in the ranged of thepredicate device gingival heights or higher.Higher gingival heights do not represent a worstcase in terms of performance. |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Same |
| Subject Device | Predicate Device | Reference Device | EQUIVALENCE DISCUSSION | |
|---|---|---|---|---|
| Part Name | Healing Abutment (Scan) | Healing Abutment | BellaTek® Encode® HealingAbutment | |
| Trade Name | CORE1 Implant System | Internal Hex Implant System | BIOMET 3i Dental Abutments&Restorative Components | |
| Manufacturer | Cybermed Inc. | EBI Inc. | BIOMET 3i, Inc. | |
| 510(k) Number | K210039 | K190837 | K072642 | |
| Usage | It is used with fixture to protect | It is used with fixture to protect the | It is used with fixture to protect the |
{19}------------------------------------------------
Image /page/19/Picture/0 description: The image shows the logo and address of Cybermed Inc. The logo is a combination of the words "CYBER" in blue and "1ED" in green. The address is "6-26, Yuseong-daero 1205 beon-gil, Yuseong -gu, Daejeon, 34104, Republic of Korea."
| the inner configuration of theimplant and maintain, stabilizeand form the soft tissue thehealing process. | inner configuration of the implantand maintain, stabilize and form thesoft tissue the healing process. | inner configuration of the implantand maintain, stabilize and form thesoft tissue the healing process. | Subject Device | Predicate Device | EQUIVALENCE DISCUSSION | |||
|---|---|---|---|---|---|---|---|---|
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Same | ||||
| Surface treatment | Machined Type | 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 | 3.8~7.5 | EquivalentThe subject device diameters are inthe range of diameters of thepredicate and reference device.Subject device was verified throughperformance test, so this differenceof range doesn't impact substantialequivalence. | ||||
| Length (mm) | G/H: 3.0/4.0/5.0/6.0/7.0 | G/H : 3.0/4.0/6.0/8.0 | EquivalentThe subject device lengths are in therange of lengths of the referencedevice.Subject device was verified throughperformance test, so this differenceof range doesn't impact substantialequivalence | |||||
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Same |
{20}------------------------------------------------
Image /page/20/Picture/0 description: The image shows the logo for Cyber 1 ED. The word "CYBER" is in blue, followed by a blue tooth-shaped graphic. The number "1" is inside the tooth graphic. The letters "ED" are in green.
| Part Name | Healing Abutment (Scan) Screw | Abutment Screw | |
|---|---|---|---|
| Trade Name | CORE1 Implant System | OSSTEM Implant System - Abutment | |
| Manufacturer | Cybermed Inc. | OSSTEM Implant Co., Ltd. | |
| 510(k) Number | K210039 | K161689 | |
| Usage | It is used for connecting HealingAbutment(Scan) to Fixture | It is used for connecting Abutment to Fixture | |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Same |
| Surface treatment | Machined Type | Machined Type | Same |
| Diameter (Ø) | 2.2/2.3 | 2.0/2.05/2.2/2.3/2.5 | EquivalentSubject devices are within the range of predicatedevices diameters. |
| Length (mm) | 9.0/10.7 | 3.35/5.6/7.5/8.35/9.6/10.2 | EquivalentThe subject device lengths are in the range oflengths of the predicate and reference device.Subject device was verified throughperformance test, so this difference of rangedoesn't impact substantial equivalence |
| Sterilization | End User Sterilization | End User Sterilization | Same |
| Subject Device | Predicate Device | EQUIVALENCE DISCUSSION | |
|---|---|---|---|
| Part Name | Universal Abutment | Multi-unit Abutment Straight | |
| Trade Name | CORE1 Implant System | IH Prosthetic System |
{21}------------------------------------------------
Image /page/21/Picture/0 description: The image shows the logo for Cyber 1 ED. The word "CYBER" is in blue, followed by a blue graphic that looks like a tooth. The letters "ED" are in green. The logo is simple and modern.
| Manufacturer | Cybermed Inc. | Sewon Medix Inc. | |
|---|---|---|---|
| 510(k) Number | K210039 | K153521 | |
| Usage | It is a premanufactured prosthetic componentdirectly connected to the endosseous dentalimplant and is intended for use as an aid inprosthetic rehabilitation | It is a premanufactured prosthetic componentdirectly connected to the endosseous dentalimplant and is intended for use as an aid inprosthetic rehabilitation | |
| Type of restoration | Multi unit | ||
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Same |
| Surface treatment | Machined Type | Machine | Same |
| Diameter (Ø) | 4.8 | 4.8 | Same |
| Length (mm) | G/H : 2.0/3.0/4.0/5.0 | G/H : 1.5/ 2.5 / 3.5 / 4.5 | EquivalentThe subject device lengths are in the range oflengths of the predicate device.Subject device was verified throughperformance test, so this difference of rangedoesn't impact substantial equivalence |
| Sterilization | End User Sterilization | End User Sterilization | Same |
| Subject Device | Predicate Device | EQUIVALENCE DISCUSSION | |
|---|---|---|---|
| Part Name | Universal Angled Abutment | Multi-Unit Abutment | |
| Trade Name | CORE1 Implant System | Internal Hex Implant System | |
| Manufacturer | Cybermed Inc. | EBI Inc. |
{22}------------------------------------------------
Image /page/22/Picture/0 description: The image shows the logo for Cyber1ED. The logo consists of the word "CYBER" in blue, followed by a blue checkmark-like symbol with a white number "1" inside. The letters "ED" are in green. The logo is simple and modern, with a focus on technology and education.
| 510(k) Number | K210039 | K190837 | |
|---|---|---|---|
| Usage | It is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation and used the multi-unit only. | It is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation and used the multi-unit only. | |
| Type of restoration | Multi unit | ||
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Same |
| Surface treatment | Machined Type | Machined type | Same |
| Diameter (Ø) | 4.8 | 4.8 | Same |
| Length (mm) | G/H : 2.0/3.0/4.0/5.0 | G/H : 1.0/2.0/2.5/3.0/3.5/4.0/5.0 | EquivalentSubject devices are within the range of predicate device's lengths. |
| Angle ( $^{\circ}$ ) | 17/30 | 0/17/30 | Equivalent |
| Sterilization | End User Sterilization | End User Sterilization | Same |
| Subject Device | Predicate Device | EQUIVALENCE DISCUSSION | |
|---|---|---|---|
| Part Name | Universal Angled Abutment Screw | Abutment Screw | |
| Trade Name | CORE1 Implant System | OSSTEM Implant System – Abutment | |
| Manufacturer | Cybermed Inc. | OSSTEM Implant Co., Ltd | |
| 510(k) Number | K210039 | K161689 |
{23}------------------------------------------------
Image /page/23/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 letters "ED" are in green. The logo is simple and modern.
| Usage | It is used for connecting Universal AngledAbutment to the Fixture. | It is used for connecting Abutment to theFixture. | |
|---|---|---|---|
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Same |
| Surface treatment | Machined Type | Machined Type | Same |
| Diameter (Ø) | 2.2 | 2.0/2.05/2.2/2.3/2.5 | EquivalentSubject devices are within the range of predicatedevice's diameters. |
| Length (mm) | 8.35/10.2 | 3.35/5.6/7.5/8.35/9.6/10.2 | EquivalentSubject devices are within the range of predicatedevice's lengths. |
| Sterilization | End User Sterilization | End User Sterilization | Same |
| Subject Device | Predicate Device | EQUIVALENCE DISCUSSION | |
|---|---|---|---|
| Part Name | Universal Ti Cylinder | Convertible Combination Cylinder | |
| Trade Name | CORE1 Implant System | ET/SS Implant System | |
| Manufacturer | Cybermed Inc. | OSSTEM Implant Co., LTD | |
| 510(k) Number | K210039 | K120847 | |
| Usage | It creates framework of the final prosthesis tobe fixed on top of the abutment. | It creates framework of the final prosthesis tobe fixed on top of the abutment. | |
| Material | Ti-6Al-4V ELI (ASTM F136) | Titanium Gr.3 (ASTM F67) | DifferentThe subject device has the different Material asthe predicate device. But both raw materials are |
{24}------------------------------------------------
Image /page/24/Picture/0 description: The image shows the logo for Cyber1ED. The logo is in blue and green. The word "CYBER" is in blue, followed by a blue tooth-shaped icon, and then the letters "1ED" in green.
| well-established because of their goodbiocompatibility performance. | |||
|---|---|---|---|
| Surface treatment | Machined Type | Machined Type | Same |
| Diameter (Ø) | 4.8 | 4.2~6.3 | EquivalentThe subject device diameters are in the range ofdiameters of the predicate device. Subjectdevice was verified through performance test, sthis difference of range doesn't impactsubstantial equivalence. |
| Length (mm) | 7.0 | 7.0 | Same |
| Sterilization | End User Sterilization | End User Sterilization | Same |
| Subject Device | Predicate Device | EQUIVALENCE DISCUSSION | |
|---|---|---|---|
| Part Name | Universal Ti Cylinder Screw | Abutment Screw | |
| Trade Name | CORE1 Implant System | OSSTEM Implant System - Abutment | |
| Manufacturer | Cybermed Inc. | Osstem Implant Co., Ltd. | |
| 510(k) Number | K210039 | K161689 | |
| Usage | It is used for connecting Universal TiCylinder, Universal Temporary Cylinder,Universal Plastic Cylinder or UniversalHealing Cap used with Universal Abutment orUniversal Angled Abutment. | It is used for connecting Abutment to theFixture. |
{25}------------------------------------------------
Image /page/25/Picture/0 description: The image shows the logo for CyberEd. The logo is in blue and green. The word "CYBER" is in blue, followed by a blue tooth-shaped icon, and then the word "ED" in green.
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Same |
|---|---|---|---|
| Surface treatment | Machined type | Machined type | Same |
| Diameter (Ø) | 2.2 | 2.0/2.05/2.2/2.3/2.5 | EquivalentThe subject device diameters are in the range ofdiameters of the predicate device. Subjectdevice was verified through performance test, sothis difference of range doesn't impactsubstantial equivalence. |
| Length (mm) | 4.0 | 3.35/5.6/7.5/8.35/9.6/10.2 | EquivalentThe subject device lengths are in the range oflengths of the predicate device. Subject devicewas verified through performance test, so thisdifference of range doesn't impact substantialequivalence |
| Sterilization | End User Sterilization | End User Sterilization | Same |
| Subject Device | Predicate Device | EQUIVALENCE DISCUSSION | |
|---|---|---|---|
| Part Name | Universal Temporary Cylinder | Multi-Unit Temporary Cylinder | - |
| Trade Name | CORE1 Implant System | Internal Hex Implant System | - |
| Manufacturer | Cybermed Inc. | EBI Inc. | - |
| 510(k) Number | K210039 | K190837 | - |
| Usage | It is for temporary prosthesis for use with the | It is for temporary prosthesis for use with the | - |
{26}------------------------------------------------
Image /page/26/Picture/0 description: The image shows the logo for Cyber 1ED. The word "CYBER" is in blue, followed by a blue tooth-shaped icon. The letters "1ED" are in green.
| Universal Abutment. | Multi-Unit Abutment. | ||
|---|---|---|---|
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI Alloy | Same |
| Surface treatment | Machined type | Machined type | Same |
| Diameter (Ø) | 4.8 | 4.8 | Same |
| Length (mm) | 12 | 12 | Same |
| Sterilization | End User Sterilization | End User Sterilization | Same |
| Subject Device | Predicate Device | EQUIVALENCE DISCUSSION | |
|---|---|---|---|
| Part Name | Universal Healing Cap | Multi-Unit Healing Cap | |
| Trade Name | CORE1 Implant System | Internal Hex Implant System | |
| Manufacturer | Cybermed Inc. | EBI Inc. | |
| 510(k) Number | K210039 | K190837 | |
| Usage | It is lead to accurate closure of soft tissuesurrounding implant and provide a definiteshape and form to gingival which isaesthetically close to natural look. | It is lead to accurate closure of soft tissuesurrounding implant and provide a definiteshape and form to gingival which isaesthetically close to natural look. | |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Same |
| Surface treatment | Machined Type | Machined type | Same |
| Diameter (Ø) | 4.8 | 4.9, 6.2 | DifferentThe subject device diameter is different frompredicate device. Minor differences in the |
{27}------------------------------------------------
Image /page/27/Picture/0 description: The image shows the logo for Cybermed. The logo consists of the word "CYBER" in blue, followed by a blue tooth-shaped icon, and then the letters "ED" in green. To the right of the logo is the word "Cybermed" in black, followed by the text "6-26, Yuseong-daero, Yuseong-gu, Daejeon, Korea".
| dimensions are not expressed to impactsubstantial equivalence because the device isonly intended during healing for protection anddesigned for compatibility to the associatedabutment. | |||
|---|---|---|---|
| Length (mm) | 5.5 | 4.2 | DifferentThe subject device length is different frompredicate device. Minor differences in thedimensions are not expressed to impact substantialequivalence because the device is only intendedduring healing for protection and designed forcompatibility to the associated abutment. |
| Sterilization | Gamma Sterilization | End User Sterilization | DifferentThe subject device sterilization is different frompredicate device. Subject device was verifiedthrough performance test, so this difference ofrange doesn't impact substantial equivalence |
| Subject Device | Predicate Device | EQUIVALENCE DISCUSSION | |
|---|---|---|---|
| Part Name | Universal Plastic Cylinder | Octa Plastic Cylinder | |
| Trade Name | CORE1 Implant System | Internal Hex Implant System | |
| Manufacturer | Cybermed Inc. | EBI Inc. | |
| 510(k) Number | K210039 | K190837 | |
| Usage | It is a burn-out device only used in the lab for | It is a burn-out device only used in the lab for |
{28}------------------------------------------------
Image /page/28/Picture/0 description: The image shows the logo for Cyber 1 ED. The logo has the word "CYBER" in blue, followed by a blue tooth-shaped icon. The number "1" is next to the tooth icon, and the letters "ED" are next to the number "1". The number "1" and the letters "ED" are in green.
| casting and is not part of the final restoration. | casting and is not part of the final restoration. | ||
|---|---|---|---|
| Material | POM(Polyoxymethylene) | POM(Polyoxymethylene) | Same |
| Diameter (Ø) | 4.8 | 5.0 | DifferentThe subject device diameter is different frompredicate device, but this difference is notimportant factor to the device performance. Thesubject device is substantial equivalent. |
| Length (mm) | 12 | 10.0 | DifferentThe subject device length is different frompredicate device, but this difference is notimportant factor to the device performance.The subject device is substantial equivalent. |
| Sterilization | End User Sterilization | End User Sterilization | Same |
K161244(s-Clean OneQ-SL Narrow Implant System), K19087 (Internal Hex Implant System) and K123988(Xpeed AnyRant System) are chosen to support additional fixture diments (diameter x length combinations) that are not covered by primary predicate K153639. s-Clean OneQ-SL Narrow Implant System K161244 was included for the additions for use language specific to our 3.3mm diameter implants. Other reference devices (K172100, K161689, K140507, K173141, K181138, K172642, K153521, K120847) were chosen because K153936 does not include all abutments with ours. We chose considering indication for use, design, material, principle of operations, length, or angulation for various abutment models. Minor differences in the dimension or length are not expected to impact substantial equivalence because subject device diameters either predicate or reference devices. Also, subject device was verified through performance test, so this difference of range doesn't impact substantial equivalence.
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Image /page/29/Picture/0 description: The image shows the logo and address of Cybermed Inc. The logo includes the word "CYBER" in blue and the number "1" in green. The address is "6-26, Yuseong-daero 1205 beon-gil, Yuseong -gu, Daejeon, 34104, Republic of Korea".
Therefore, any difference doesn't impact the substantial equivalence.
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Image /page/30/Picture/0 description: The image shows the logo for Cyber 1ED. The word "CYBER" is in blue, followed by a blue tooth-shaped icon. The letters "1ED" are in green. The logo is simple and modern, and the colors are bright and eye-catching.
VII. NON-CLINICAL TESTING
The subject device was tested to evaluate its substantial equivalence according to the following standards.
· Bacterial endotoxin test performed according to The United States Pharmacopoeia (USP) <85><161> and ANSVAAMI ST72:2011 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing. The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device. As a result of endotoxin test validation for the product, it was confirmed that the endotoxin test reagent (PTS cartridge) and the laboratory environment were suitable for endotoxin test by the initial qualification test. Endotoxin Test concludes that the product is suitable for endotoxin testing using both PTS readers and PTS cartridge, meeting both endotoxin standards and established criteria for testing.
· Fatigue Testing performed according to ISO 14801:2016 and FDA guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". Comparative fatigue testing was performed subject device and reference device K190837 to confirm covering permanent restoration of the implant without failure.
· Surface Analysis performed by SEM & EDS. Analysis results indicated that there was surface roughness leading to a macroroughness and no other impurity on the surface of the final product.
Gamma sterilization validation performed according to ISO 11137-. 1:2006/Amd.1:2013 Sterilization of health care products -Requirements for validation and routine control - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, ISO 11137-2:2013 Sterilization of health care products -Requirements for validation and routine control - Radiation - Part 2 : Establishing the sterilization dose, and ISO 11137-3:2006 Sterilization of health care products -Requirements for validation and routine control - Radiation - Part 3 : Guidance on dosimetric aspects. It was acceptable range of densities of other product in carrier and confirm to process
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Image /page/31/Picture/0 description: The image shows the logo for CyberEd. The word "CYBER" is in blue, followed by a blue tooth-shaped icon. The letters "ED" are in green.
stability. Based on these, the packaging with gamma sterilization of the subject is equivalent to the packaging of the predicate and reference device. The shelf life for devices provided sterile is 5 years.
· End user sterilization for abutment performed according to ISO 17665-1:2006 "Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices", ISO 17665-2:2009 "Sterilization of health care products - Moist heat - Part Guidance on on the application of of ISO 17665-1"and ANSI/AAMI 2: ST79:2010/A4:2013 "Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 3"
· Biocompatibility testing performed according to ISO 10993-1:2018 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: September 4, 2020" for each of the subject devices, and ISO 10993-5:2009 "Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity".
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate devices.
SUBSTANTIAL EQUIVALENCE DISCUSSION VIII.
The subject device, CORE1 implant system, has same device characteristics with the primary predicate and reference devices as dental implant system. It is intended purpose as they are placed in the alveolar bone to replace the function of missing tooth.
The various dimensions of subject devices are slightly different from the predicate devices. However, the dimensions of the subject device are in the range of the dimensions of the predicate and reference devices. Also, subject device was verified through performance test, so this difference of range doesn't impact substantial
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Image /page/32/Picture/0 description: The image shows the logo for Cyber1ED. The word "CYBER" is in blue, followed by a blue tooth shape with the number "1" inside. The letters "ED" are in green. The logo is simple and modern.
equivalence. The bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics doesn't impact substantial equivalence.
Therefore, it is concluded that CORE1 implant system is substantially equivalent to the predicate devices.
§ 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.