(244 days)
ZENEX Implant System Long is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
ZENEX Implants in the 20 mm length when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
ZENEX Implant System_Long is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone in order to support or maintain the prosthetic tooth or denture when a patient's teeth are partially or totally lost.
The fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching).
There are 2 types of fixtures, and the dimensions are as following:
| Name | Fixture Type | Diameter (mm) | Length (mm) | Material |
|---|---|---|---|---|
| ZENEX ImplantSystem_Long(ZENEX MULTIFixture) | Image: Fixture Type 1 | Ø 3.75/4.25 | 18mm/20mm | |
| Ø 4.6 | 18mm | |||
| ZENEX ImplantSystem_Long(ZENEX PLUSFixture) | Image: Fixture Type 2 | Ø 3.75/4.25 | 18mm/20mm | |
| Ø 4.6 | 18mm |
The subject devices are compatible with the following abutments made by Izenimplant Co., Ltd.
ZENEX Implant System_Long is provided sterile, and valid for 5 years.
This document describes a 510(k) premarket notification for the ZENEX Implant System Long, an endosseous dental implant. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on non-clinical testing and comparisons to predicate devices, rather than a study proving the device meets acceptance criteria in a clinical setting.
Here's an analysis of the provided information based on your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for substantial equivalence based primarily on non-clinical testing, there isn't a direct "acceptance criterion" table in the sense of clinical performance metrics (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are the successful completion of various non-clinical tests according to established standards, demonstrating that the new device is as safe and effective as the predicate devices.
| Acceptance Criterion (Non-Clinical Test) | Reported Device Performance |
|---|---|
| Fatigue Testing (ISO 14801:2016) | Subject devices demonstrated substantial equivalence to predicate devices under worst-case scenario. |
| Biocompatibility Testing (ISO 10993-1, -3, -5, -6, -10, -11) | Leveraged from predicate K211090; demonstrated biocompatibility and substantial equivalence. |
| Gamma Sterilization Validation (ISO 11137-1, -2, -3) | Validated to a sterility assurance level (SAL) of 10⁻⁶. |
| Shelf Life Testing (ASTM F1980) | Worst-case construct tested; demonstrated equivalence to predicate devices for a 5-year shelf life. |
| Bacterial Endotoxin Test (ANSI/AAMI ST72:2011, USP <161>, <85>) | Leveraged from predicate K211090. |
| Surface Modification Information (SEM imaging, roughness, composition for SLA) | Leveraged from predicate K211090. |
| MR Environment Condition Review (FDA Guidance, published literature) | Non-clinical worst-case MRI review performed; MR Conditional Labeling leveraged from K211090. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of a clinical study. For non-clinical tests:
- Fatigue Testing: The number of implant samples subjected to fatigue testing according to ISO 14801 is not specified (e.g., "n="). The standard usually specifies minimum sample sizes.
- For other tests (Biocompatibility, Sterilization, Shelf Life, Bacterial Endotoxin, Surface Modification), the sample sizes are not provided as these were either leveraged from the predicate device or conducted per standard protocols without explicit counts in this document.
- Data Provenance: The document generally refers to "non-clinical testing data." Specific countries of origin for the non-clinical testing are not provided. The main submitter (Izenimplant Co., Ltd.) is from the Republic of Korea. The testing itself would typically be performed by accredited labs. The studies were retrospective in the sense that data from already cleared predicate devices were leveraged. The fatigue testing for the subject device was newly performed, making it prospective for that specific test on the new design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable in this context. Since this is a 510(k) submission based on non-clinical testing for substantial equivalence, there is no "ground truth" derived from expert clinical assessment of patient data (e.g., radiologists interpreting images) for a "test set" in the way it would be for an AI/CADe device. The "ground truth" for non-clinical tests is established by adhering to recognized international standards and laboratory protocols.
4. Adjudication Method for the Test Set
This information is not applicable. There was no "test set" in a clinical diagnostic sense requiring expert adjudication. Non-clinical tests typically involve objective measurements according to defined 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
This information is not applicable. The device is an endosseous dental implant, not an AI or CADe diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
For non-clinical tests, the "ground truth" is defined by the established international or national standards and protocols for each test (e.g., ISO 14801 for fatigue testing, ISO 10993 for biocompatibility). The results are compared against these benchmarks or against the performance of predicate devices tested under the same conditions.
8. The Sample Size for the Training Set
This information is not applicable. The device is an endosseous dental implant. There is no concept of a "training set" as would be used for machine learning models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no training set for a machine learning model, there is no ground truth established for one.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Izenimplant Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
October 30, 3024
Re: K240560
Trade/Device Name: ZENEX Implant System Long Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: February 28, 2024 Received: October 08, 2024
Dear April Lee:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
{2}------------------------------------------------
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 -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240560
Device Name ZENEX Implant System Long
Indications for Use (Describe)
ZENEX Implant System Long is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
ZENEX Implants in the 20 mm length when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Submitter
Izenimplant Co., Ltd. Ji-Hwan Jeong 1, 2Dong, 26-32, Suworam 4-Gil, Seotan-Myeon, Pyeongtaek-Si, Gyeonggi, 17703 Republic of Korea Email: jjhwan@izenimplant.com Tel. +82-31-662-0657 Fax. +82-31-662-0655
Official Correspondent
Withus Group Inc April Lee 106 Superior Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
Device Information
- Trade Name: ZENEX Implant System Long ●
- Common Name: Endosseous Dental Implant ●
- Classification Name: Implant, Endosseous, Root-Form
- Primary Product Code: DZE
- Panel: Dental
- Regulation Number: 21 CFR 872.3640
- Device Class: Class II
- . Date Prepared: 10/30/2024
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- . K211090, Zenex Implant System manufactured by Izenimplant Co., Ltd.
Reference Devices
- K161604, Osstem Implant System manufactured by OSSTEM Implant Co., Ltd.
- K221453, S.I.N. Dental Implant System manufactured by S.I.N. Sistema de Implante Nacional ● S.A.
- K222778. Osstem Implant System manufactured by OSSTEM Implant Co., Ltd.
- . K232418, Single Platform SP1 Implant System manufactured by Southern Implants (Pty) Ltd.
Indications for Use:
ZENEX Implant System Long is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
ZENEX Implants in the 20 mm length when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
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Device Description
ZENEX Implant System_Long is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone in order to support or maintain the prosthetic tooth or denture when a patient's teeth are partially or totally lost.
The fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching).
| Name | Fixture Type | Diameter (mm) | Length (mm) | Material |
|---|---|---|---|---|
| ZENEX ImplantSystem_Long(ZENEX MULTIFixture) | Image: Fixture Type 1 | $Ø$ 3.75/4.25 | 18mm/20mm | |
| $Ø$ 4.6 | 18mm | |||
| ZENEX ImplantSystem_Long(ZENEX PLUSFixture) | Image: Fixture Type 2 | $Ø$ 3.75/4.25 | 18mm/20mm | |
| $Ø$ 4.6 | 18mm |
There are 2 types of fixtures, and the dimensions are as following:
Tolerance of dimension shall be within ± 1% range.
| 510(K) | AbutmentName | Diameter (Ø) | Angulation | Length orCuff(mm) | Multi-unitLoading |
|---|---|---|---|---|---|
| K211090 | CoverScrew | I-System: Ø3.45 / Ø3.6T-System: Ø3.0/Ø3.4/Ø3.6/Ø3.9 | 0° | P/H: 0.4/1.4/2.0 | |
| HealingAbutment | I-System:Ø4.3/Ø4.8/Ø5.5/Ø6.0/Ø6.8/Ø8.0/09.0T-System:Ø4.3/Ø4.8/Ø5.3/Ø6.3/Ø7.3/Ø8.3 | 0° | P/H: 2/3/4/5/6/7/9 | ||
| CementedAbutment | I-System: Ø4.5/Ø5.2/Ø5.7/Ø6.5T-System:Ø4.0/Ø4.5/Ø5.0/Ø6.0/Ø7.0 | 0° | G/H: 1/2/3/4/5/6/7PH: 4/5/5.5/7 | Bridges | |
| AngledAbutment | I-System: Ø4.5/Ø5.2/Ø5.7T-System: Ø4.0/Ø4.5/Ø5.0/Ø6.0 | I-System: 15°/25°T-System: 17° | G/H: 2/3/4P/H: 7 | Bridges | |
| TemporaryAbutment | I-System: Ø4.5T-System: Ø4.0/Ø4.5 | 0° | G/H: 1/3P/H: 10 | ||
| BallAbutment | I-System: Ø3.5T-System: Ø3.5 | N/A | G/H: 1/2/3/4/5/6 | Overdentures | |
| AbutmentScrew | I-System: Ø2.3T-System: Ø2.2/Ø2.3 | N/A | I-System: 8.2T-System:8.35/10.2 |
The subject devices are compatible with the following abutments made by Izenimplant Co., Ltd.
ZENEX Implant System_Long is provided sterile, and valid for 5 years.
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Summaries of Technological Characteristics:
ZENEX Implant System_Long are similar to other commercially available products based on the intended used, the claims, the material composition employed and performance characteristics.
| Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|---|---|
| Company | Izenimplant Co., Ltd. | Izenimplant Co., Ltd. | OSSTEM ImplantCo., Ltd. | OSSTEM ImplantCo., Ltd. | S.I.N. - Sistema deImplante Nacional S.A. | Southern Implants (Pty) Ltd |
| Device Name | ZENEX ImplantSystem Long | ZENEX ImplantSystem | Osstem ImplantSystem | Osstem ImplantSystem | S.I.N. Dental ImplantSystem | Single Platform SP1 ImplantSystem |
| 510(k) Number | N/A | K211090 | K222778 | K161604 | K221453 | K232418 |
| DeviceClassificationName | Implant, Endosseous,Root-Form | Implant, Endosseous,Root-Form | Implant.Endosseous.Root-Form | Implant, Endosseous,Root-Form | Implant, Endosseous,Root-Form | Implant, Endosseous,Root-Form |
| Product Code | DZE | DZE | DZE, NHA | DZE, NHA | DZE, NHA | DZE |
| RegulationNumber | 872.3640 | 872.3640 | 872.3640 | 872.3640 | 872.3640 | 872.3640 |
| Reason forPredicate/Reference Device | Indications for UseDesign of implants andabutments, Materials | Ø3.75 x L18,20Implant | Ø4.6 X L18 Implant | Implant that can containØ4.25 X L18. 20 | 20, 22 and 24 mm length ofImplants | |
| Intended Use | ZENEX ImplantSystem_Long is indicatedfor use in partially orfully edentulousmandibles and maxillae,in support of single ormultiple unit restorationsincluding; cementedretained, screw retained,or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is intendedfor delayed loading.ZENEX Implants in the20 mm length whenplaced in the maxilla areonly indicated formultiple unit restorationsin splinted applicationsthat utilize at least twoimplants. | ZENEX ImplantSystem is indicated foruse in partially or fullyedentulous mandiblesand maxillae, in supportof single or multipleunit restorationsincluding; cementedretained, screw retained,or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It isintended for delayedloading. Wide FixtureSystem is intended to beused in the molar region | The Osstem ImplantSystem is indicatedfor use in partiallyor fully edentulousmandibles andmaxillae, in supportof single ormultiple-unitsrestorationsincluding; cementedretained, screwretained, oroverdenturerestorations, andfinal or temporaryabutment supportfor fixedbridgework. It isintended for delayedloading. Ultra wideImplant system isintended to be usedin the molar region. | The Osstem ImplantSystem is indicatedfor use in partially orfully edentulousmandibles andmaxillae, in supportof single or multiple-units restorationsincluding; cementedretained, screwretained, oroverdenturerestorations, and finalor temporaryabutment support forfixed bridgework. It isintended for delayedloading. Ultra wideImplant system isintended to be used inthe molar region.Products withdiameter or less than | S.I.N. Dental ImplantSystem is intended forplacement in themaxillary or mandibulararch to provide supportfor single-unit or multi-unit restorations. When aone-stage surgicalapproach is applied, theS.I.N. Dental ImplantSystem is intended forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading.S.I.N. Dental ImplantSystem implants withlengths of 18, 20, 22, or24 mm may be tilted up to30°. When used in themandible or maxilla withimplants with lengths of | The Single Platform SPIImplant System is intendedfor surgical placement in theupper or lower jaw to providea means for prostheticattachment of crowns, bridgesor overdentures utilizingdelayed or immediate loading.The Single Platform SPIImplant System is intendedfor immediate function whengood primary stability withappropriate occlusal loadingis achieved. The SinglePlatform SPI implants inlengths 20, 22 and 24 mmwhen placed in the maxillaare only indicated for multipleunit restorations in splintedapplications that utilize atleast two implants. For theconventional abutment andscrews: The Conventional |
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| Products with | 3.25mm should be | 18, 20, 22, or 24 mm at an | Abutments and Prosthetic | |
|---|---|---|---|---|
| diameter or less | used exclusively for | angulation of 30°, a | Screws are premanufactured | |
| than 3.25mm should | the lateral incisor in | minimum of four implants | prosthetic components | |
| be used exclusively | the maxilla and a | must be used and must be | directly connected to | |
| for the lateral | central or lateral | splinted. When placed in | endosseous dental implants | |
| incisor in the | incisor in the | the maxilla with lengths | and intended for use in fully | |
| maxilla and a | mandible. | of 18, 20, 22, or 24 mm at | edentulous or partially | |
| central or lateral | angulations between 0° | edentulous maxilla and/or | ||
| incisor in the | and less than 30°, the | mandible to provide support | ||
| mandible. | S.I.N. Dental Implant | for crowns, bridges or | ||
| System implants are only | overdentures. For the | |||
| indicated for multiple unit | Titanium Abutment Bases | |||
| restorations in splinted | and Passive Abutments: The | |||
| applications that utilize at | TIB and Passive Abutments | |||
| least two implants. | are premanufactured | |||
| All digitally-designed | prosthetic components | |||
| custom abutments for use | directly connected to | |||
| with Interface CAD-CAM | endosseous dental implants | |||
| abutments are to be sent | and are intended for use as an | |||
| to a S.I.N.-validated | aid in prosthetic | |||
| milling center formanufacture. | rehabilitation. The TIB andPassive abutments consist of | |||
| two major parts. Specifically, | ||||
| the titanium base and | ||||
| mesostructure components | ||||
| make up a two-piece | ||||
| abutment. The system | ||||
| integrates multiple | ||||
| components of the digital | ||||
| dentistry workflow: Scan files | ||||
| from desktop scanners, CAD | ||||
| software, CAM software, | ||||
| ceramic material, milling | ||||
| machine and associated | ||||
| tooling and accessories. For | ||||
| the Temporary Titanium | ||||
| Cylinders: The Southern | ||||
| Implants Temporary Titanium | ||||
| Abutments are | ||||
| premanufactured prosthetic | ||||
| components directly | ||||
| connected to endosseous | ||||
| dental implants and are | ||||
| intended for provisional use | ||||
| up to 180 days as an aid in | ||||
| prosthetic rehabilitation |
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| Material | Titanium Grade 4 ofASTM F67 | Titanium Grade 4 ofASTM F67 | Titanium Grade 4 ofASTM F67 | Titanium Grade 4 ofASTM F67 | Titanium Grade 4 ofASTM F67 | Titanium Grade 4 of ASTMF67 | good primary stability isachieved and withappropriate occlusalloading. | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Design | Image: Titanium Grade 4 of ASTM F67 | Image: Titanium Grade 4 of ASTM F67 | Image: Titanium Grade 4 of ASTM F67 | Image: Titanium Grade 4 of ASTM F67 | Image: Titanium Grade 4 of ASTM F67 | Image: Titanium Grade 4 of ASTM F67 | Shelf Life | 5 Years | 5 Years | 8 Years | 8 Years | 4 Years | 10 Years | |
| Structure | - Internal Hex connected- Submerged Fixture- Straight/Taper bodyshape | - Internal Hexconnected- Submerged Fixture- Straight/Taper bodyshape | - Internal Hexconnected | - Internal Hexconnected | - Internal Hex connected | Internal Cone and Hex | CompatibleAbutments | Straight and angledabutments | Straight and angledabutments | Straight and angledabutments | Straight and angledabutments | Straight and angledabutments | Straight and angled abutments | |
| Diameters (Ø)X Lengths (mm) | Ø3.75X L18, 20Ø4.25 X L18, 20Ø4.6 X L18 | Ø3.75XL8.5, 10, 11.5,13, 15Ø4.25X L7, 8.5, 10,11.5, 13, 15Ø4.6X L7, 8.5, 10, 11.5,13, 15Ø5.05X L7, 8.5, 10,11.5, 13, 15Ø5.4X L7, 8.5, 10, 11.5,13Ø5.9X L7, 8.5, 10, 11.5,13Ø6.75X L7, 8.5, 10,11.5, 13 | Ø3.75 x L18,20Ø3.77 x L7Ø4.25 x L7Ø4.65 x L7Ø5.45 xL10,11.5,13,15Ø5.48 x L8.5Ø5.5 x L7 | Ø3.2 XL8.5,10,11.5,13,15Ø4.4 XL7,8.5,10,11.5,13,15Ø4.6 X L18Ø4.8 XL7,8.5,10,11.5,13,15Ø5.05 X L18Ø5.25 XL7,8.5,10,11.5,13,15Ø6.2 XL6.2,7,8.5,10,11.5,13Ø7.1 XL6.2,7,8.5,10,11.5,13 | Ø3.8 X L18,20,22,24Ø4.0 X L18,20,22,24Ø4.5 X L18,20,22,24 | Ø3.5 XL8,10,11.5,13,16,18,20Ø4.0 XL8,10,11.5,13,16,18,20,22,24Ø5.0 X L8,10,11.5,13,16,18 | Similarities | The ZENEX Implant System_Long have same device characteristics with the Primary devices, ZENEX Implant System (K211090) such as the intended use, material,functions, general shape (Design), connection type, structure and applied production method are similar. | ||||||
| Surface Treatment | Sand blasting & AcidEtching | Sand blasting & AcidEtching | Sand blasting &Acid Etching | Sand blasting & AcidEtching | Acid Etched | Grit-blasted with a 3.0mmmachined section only atcoronal end | Differences | The differences between the subject device and the primary device, ZENEX Implant System (K211090) are the indications for Use and fixture length. The reason forthe difference of the indications for use between two devices is the subject device system does not include wide fixtures which is intended to be used in the molarregion. The whole length of the subject device is longer than the primary Device. To support this discrepancy, K222778, K161604 and K221453 was added, and itcovers all range of the fixture diameter and length combination. The Single Platform SPI implants (K232418) in lengths 20, 22 and 24 mm when placed in themaxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Therefore, these differences don't affect the device'sfundamental functions, safety and effectiveness. | ||||||
| Sterilization | Gamma Sterilization | Gamma Sterilization | GammaSterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | ||||||||
| Principle ofOperation | This product is a root-type fixture which isinserted in the alveolarbone. It replaces thefunctions of the missingteeth as a dental implantfixture. | This product is a root-type fixture which isinserted in the alveolarbone. It replaces thefunctions of the missingteeth as a dental implantfixture. | This product is aroot-type fixturewhich is inserted inthe alveolar bone. Itreplaces thefunctions of themissing teeth as adental implantfixture | This product is a root-type fixture which isinserted in thealveolar bone. Itreplaces the functionsof the missing teeth asa dental implantfixture | S.I.N. Dental ImplantSystem is intended forplacement in themaxillary or mandibulararch to provide supportfor single-unit or multi-unit restorations. When aone-stage surgicalapproach is applied, theS.I.N. Dental ImplantSystem is intended forimmediate loading when | The Conventional Abutmentsand Prosthetic Screws arepremanufactured prostheticcomponents directlyconnected to endosseousdental implants and intendedfor use in fully edentulous orpartially edentulous maxillaand/or mandible to providesupport for crowns, bridges oroverdentures. |
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Non-clinical testing data:
Below tests were performed on subject device:
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Fatigue Testing according to ISO 14801:2016 under the worst-case scenario ●
Below tests were performed for predicate device, K211090 and leveraged for the subject device: -
Biocompatibility testing according to ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-● 5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006
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Gamma sterilization validation Test Report according to ISO 11137-1. ISO 11137-2 and ISO . 11137-3
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Shelf Life Test on Fixtures according to ASTM F 1980 ●
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. Bacterial Endotoxin Test Report on Fixtures according to ANSI/AAMI ST72:2011, USP <161>, and USP <85>
The surface modification information such as surface roughness, surface composition analysis, and SEM imaging with SLA (Sandblasted with Large-grit and Acid-etching) for fixtures was leveraged from K211090.
Sterilization and Shelf Life Testing
For devices provided sterile, a sterility assurance level (SAL) of 10 6 have been validated in accordance with ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
Shelf Life Testing was performed in accordance with ASTM F1980, Standard Guide for Accelerated Aging of Sterile Medical Device Packages. The worst-case construct was tested, and results demonstrated equivalence to the predicate devices. The shelf life for devices provided sterile is 5 years.
Biocompatibility Testing
The Biocompatibility Test was conducted on the predicate device, K211090 and leveraged for the subject device because both products are manufactured with the same material and manufacturing process. It demonstrates that the subject device is biocompatible and substantial equivalence with the predicate.
Fatigue Testing
Due to the length of the subject devices. Dynamic fatigue tests were newly performed to demonstrate the mechanical value according to the FDA guidance document "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801. The Results of fatigue testing showed that subject devices are substantially equivalent under the worst-case scenario.
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic ZENEX Implant System_Long in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force
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and Torque on Metal Alloys Used in Medical Devices". Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. MR Conditional Labeling was leveraged from K211090.
The results of the above non-clinical tests have met the standards and demonstrated the substantial equivalence with the predicate device.
Conclusion
ZENEX Implant System_Long constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has similar intended use and fundamental scientific technology as its predicate devices. Therefore, ZENEX Implant System_Long and their predicates are substantially equivalent.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.