(146 days)
The ZENEX Implant System Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
The implants may be restored immediately
- with a temporary prosthesis that is not in functional occlusion,
- when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
- for denture stabilization using multiple implants in the anterior mandible and maxilla.
The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.
The ZENEX Implant System Narrow consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The fixtures and abutments in this system are: ZENEX MULTI Fixture, ZENEX PLUS Fixture, Cover Screw, Healing Abutment, Cemented Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Temporary Abutment (Hex, Non-Hex), FreeMilling Abutment (Hex, Non-Hex), CCM Cast Abutment (Hex, Non-Hex), and Abutment Screw. An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the ZENEX MULTI and PLUS Fixtures are treated with SLA(sand-blasted, large-grit, acid-etched). The subject fixture, cover screw and healing abutment are provided sterile. Other abutments are provided non-sterile and packaged separately.
The provided text is a 510(k) summary for the ZENEX Implant System Narrow, a dental implant device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria and performance studies for an AI/ML device cannot be extracted from this document.
The document details:
- Device Description: Components (fixtures, abutments), materials (Ti-6Al-4V ELI, Co-Cr-Mo Alloy), and surface treatments (SLA, TiN coated).
- Indications for Use: Single tooth replacement, multiple tooth replacement, denture stabilization.
- Predicate Devices: A list of previously cleared dental implants and accessories used for comparison.
- Substantial Equivalence Discussion: A comparative table outlining various characteristics of the subject device against its primary predicate and reference devices, focusing on design, connection, material, surface, sterilization, shelf life, and indications for use.
- Non-Clinical Data: Lists mechanical and material tests conducted (Bacterial Endotoxin, Fatigue Testing on fixture) and leveraged from predicate devices (Sterilization Validation, Shelf-Life, End User Sterilization Validation, Biocompatibility). It also mentions an MR environment review.
There is no information in this document about:
- Acceptance criteria for an AI/ML device.
- Reported device performance metrics (e.g., sensitivity, specificity, accuracy) of an AI/ML device.
- Sample sizes for test sets in an AI/ML study.
- Data provenance for an AI/ML study.
- Number or qualifications of experts for AI/ML ground truth.
- Adjudication methods for AI/ML ground truth.
- MRMC comparative effectiveness study results for AI/ML.
- Standalone performance of an AI/ML algorithm.
- Type of ground truth used for an AI/ML study.
- Sample size for the training set of an AI/ML model.
- How ground truth for the training set was established for an AI/ML model.
This 510(k) summary is for a physical dental implant system, not a software or AI/ML-driven device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Izenimplant Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K230630
Trade/Device Name: ZENEX Implant System Narrow Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 5, 2023 Received: July 5, 2023
Dear April Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230630
Device Name ZENEX Implant System Narrow
Indications for Use (Describe)
The ZENEX Implant System Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
The implants may be restored immediately
-
with a temporary prosthesis that is not in functional occlusion,
-
when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
-
- for denture stabilization using multiple implants in the anterior mandible and maxilla.
The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.
- for denture stabilization using multiple implants in the anterior mandible and maxilla.
| 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. Kwon, Mi-Kyung 1, 2Dong, 26-32, Suworam 4-Gil, Seotan-Myeon, Pyeongtaek-Si, Gyeonggi, 17703 Republic of Korea Email: mkkwon@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 Narrow
- Common Name: Endosseous Dental Implant
- . Classification Name: Implant, Endosseous, Root-Form
- Product Code: DZE
- . Secondary Product Code: NHA
- . Panel: Dental
- . Regulation Number: 872.3640
- . Date prepared: 07/28/2023
Predicate Devices:
The subject device is substantially equivalent to the following Devices:
Primary Predicate K161244, s-Clean OneQ-SL Narrow Implant System manufactured by Dentis Co., Ltd.
Reference Device
K161604, OSSTEM Implant System by Osstem Implant Co., Ltd.
K161987, UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure by DIO Corporation
K172100, URIS OMNI System by TruAbutment Korea Co.,Ltd.
K182081, JDentalCare Implant System JDIcon by J Dental Care S.R.L.
K182194, UV Active Implant System by DIO Corporation
K190849. IS-III active System S-narrow Type by Neobiotech Co., Ltd.
K211090, ZENEX Implant System by Izenimplant Co., Ltd.
K220079, Magicore Narrow System by InnobioSurg Co., Ltd.
Indications for Use
The ZENEX Implant System Narrow (3.0. 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
The implants may be restored immediately
-
with a temporary prosthesis that is not in functional occlusion,
-
when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
-
for denture stabilization using multiple implants in the anterior mandible and maxilla.
The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.
{4}------------------------------------------------
Device Description:
The fixtures and abutments in this system are below:
- Fixture
- . ZENEX MULTI Fixture
- . ZENEX PLUS Fixture
-
- Abutment
- Cover Screw ●
- Healing Abutment
- Cemented Abutment (Hex, Non-Hex) ●
- Angled Abutment (Hex, Non-Hex)
- Temporary Abutment (Hex, Non-Hex) ●
- FreeMilling Abutment (Hex, Non-Hex)
- CCM Cast Abutment (Hex, Non-Hex) ●
- . Abutment Screw
An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The ZENEX Implant System Narrow consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations.
The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the ZENEX MULTI and PLUS Fixtures are treated with SLA(sand-blasted, large-grit, acid-etched).
| Fixture | CompatibleAbutment | AbutmentDiameter | Abutment Length (mm) | AbutmentAngle |
|---|---|---|---|---|
| ZENEXPLUSFixtureØ 3.0X10, 11.5,13, 15mm | Cover Screw | Ø2.6 | 4.0 | 0° |
| HealingAbutment | Ø4.0 | 7/8/9/10/11/13 | 0° | |
| CementedAbutment | Ø4.0 | Hex: 9.5/10.5/11.5/11/11.5/12/12.5/13/14Non-Hex: 9/10/10.5/11/11.5/12/12.5/13.5 | 0° | |
| AngledAbutment | Ø4.0 | Hex: 11/13Non-Hex: 10.5/12.5 | 15° | |
| TemporaryAbutment | Ø4.0 | Hex: 13/15Non-Hex: 12.5/14.5 | 0° | |
| FreeMillingAbutment | Ø4.0 | Hex: 13/15Non-Hex: 12.5/14.5 | 0° | |
| CCM CastAbutment | Ø4.0 | Hex: 13/15Non-Hex: 12.5/14.5 | 0° |
ZENEX Plus Fixture is compatible with the subject abutments as below:
ZENEX MULTI Fixture is compatible with the abutments cleared in K211090 except cover screw as below:
| Fixture | CompatibleAbutment | AbutmentDiameter | Abutment Length (mm) | AbutmentAngle |
|---|---|---|---|---|
| ZENEXMULTIFixture | Cover Screw(Subject device) | Ø2.9/ Ø3.2 | 4.5/5.5/6.1 | 0° |
| Healing Abutment | Ø4.3/ Ø4.8 | 7.5/8.5/9.5/11.5/13.5 | 0° | |
| Ø 3.2X8.5, 10,11.5, 13,15mm | CementedAbutment | Ø4.0/ Ø4.5 | Hex:9.08/10.08/10.58/11.08/11.58/12.08/12.58/13.08/13.58/14.08/14.58/15.08/15.58/16.08/16.58Non-Hex:8.48/9.48/9.98/10.48/10.98/11.48/11.98/12.48/12.98/13.48/13.98/14.48/14.98/15.98 | 0° |
| TemporaryAbutment | Ø4.0 | Hex:13.58/15.58Non-Hex: 12.98/14.98 | 0° |
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| Abutments | Uses | Surface Treatment |
|---|---|---|
| Cover Screw | The cover Screw is used during the healing period prior torestorations and maintain the shape of the gum | Non |
| Healing Abutment | The Abutment is used during the healing period prior torestorations and maintain the shape of the gum. | Non |
| Cemented Abutment(Hex, Non-Hex) | The Abutment is connected with fixture, and it supportsprosthesis which restores tooth function. | Partial TiN coatedin upper |
| Angled Abutment(Hex, Non-Hex) | The Abutment is connected with fixture, and it supportsprosthesis which restores tooth function. | Partial TiN coatedin upper |
| Temporary Abutment(Hex, Non-Hex) | The Abutment is used by removing the healing abutment as anabutment for making temporary prostheses | Non |
| FreeMilling Abutment(Hex, Non-Hex) | The Abutment is connected with fixture, and it supportsprosthesis which restores tooth function.The FreeMilling Abutment is only intended to be modified byhand-milling. | Partial TiN coatedin upper |
| CCM Cast Abutment(Hex, Non-Hex) | It is used when there are restrictions on the prosthesisproduction because of path, aesthetics, and space of fixture.Production the prosthesis by casting with dental alloy after waxup with desired shape | Non |
| Abutment Screw | Connection body to connect abutment to fixture. | Non |
Below are the abutment's features:
The subject fixture, cover screw and healing abutment are provided sterile.
Other abutments are provided non-sterile and packaged separately. The abutments should be sterilized before use by End User sterilization.
Materials:
- ZENEX Implant Narrow Fixtures and abutments are made of Ti-6Al-4V Eli
- -CCM Cast Abutment is made of Co-Cr-Mo Alloy
{6}------------------------------------------------
K230630
Summaries of Technological Characteristics & Substantial Equivalence Discussion
Fixture – ZENEX MULTI Fixture and ZENEX PLUS Fixture
| Subject Device | Primary Predicate | Reference Device | Reference Device | |
|---|---|---|---|---|
| Manufacturer | Izenimplant Co.,Ltd | Dentis Co., Ltd. | InnoBioSurg Co.,Ltd | Neobiotech Co., Ltd |
| Product Name | ZENEX Implant | s-Clean OneQ-SL Narrow | Magicore Narrow System | IS-III active System_ |
| System_Narrow | Implant System | S-Narrow Type | ||
| 510(K) # | K230630 | K161244 | K220079 | K190849 |
| Classification | Class II | Class II | Class II | Class II |
| Design | Image: ZENEX Implant System_Narrow Design | Image: s-Clean OneQ-SL Narrow Implant System Design | Image: Magicore Narrow System Design | Image: IS-III active System_S-Narrow Type Design |
| Connection | Internal Hex | Internal Hex | Internal Hex | Internal Hex |
| EndosseousImplant | Tapered, macro threads | Tapered, macro threads | Tapered, macro threads | Tapered, macro threads |
| SurgicalTechnique | 1 and 2 stage, self-tapping | 1 and 2 stage, self-tapping | 1 and 2 stage, self-tapping | 1 and 2 stage, self-tapping |
| Diameter andLength(mm) | • Ф3.0mmX10,11.5,13,15 mm | Ф3.0, 3.3mm X10,12,14mm | Ф3.0mm11,13,15mm | Ф3.2mm8.5/10.0/11.5/13.0/15.0 |
| • Ф3.2mm X8.5,10,11.5,13,15 mm | ||||
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Surface | Sandblasted and acid-etched | Sandblasted and acid-etched | Sandblasted and acid-etched | Sandblasted and acid-etched |
| Sterilization | Radiation | Radiation | Radiation | Radiation |
| Shelf life | 5 years | 8 years | 8 years | 5 years |
| Indications foruse | The ZENEX ImplantSystem_Narrow (3.0,3.2mm) may be used as anartificial root structure for | The s-Clean OneQ-SL NarrowImplant System (3.0, 3.3mm)may be used as an artificialroot structure for single tooth | The Magicore Narrow System(3.0, 3.5mm) may be used as anartificial root structure for singletooth replacement of mandibular | The IS-III active System_S-narrow Type is indicated for usein surgical and restorativeapplications for placement in the |
| single tooth replacement ofmandibular central andlateral incisors andmaxillary lateral incisors.The implants may berestored immediately | replacement of mandibularcentral and lateral incisors andmaxillary lateral incisors.The implants may be restoredimmediately1) with a temporary prosthesisthat is not in functionalocclusion, | central and lateral incisors andmaxillary lateral incisors.The implants may be restoredimmediately1) with a temporary prosthesisthat is not in functional occlusion,2) when splinted together as anartificial root structure for | mandibular central, lateralincisor and maxillary lateralincisor regions of partiallyedentulous jaws where thehorizontal space is limited by theadjacent teeth and roots, toprovide support for prostheticdevices, such as artificial teeth, | |
| 1) with a temporaryprosthesis that is not infunctional occlusion,2) when splinted together asan artificial root structure formultiple tooth replacementof mandibular incisors, or3) for denture stabilizationusing multiple implants inthe anterior mandible andmaxilla.The implants may be placedin immediate function whengood primary stability hasbeen achieved and withappropriate occlusal loading. | 2) when splinted together as anartificial root structure formultiple tooth replacement ofmandibular incisors, or3) for denture stabilizationusing multiple implants in theanterior mandible and maxilla.The implants may be placed inimmediate function when goodprimary stability has beenachieved and with appropriateocclusal loading. | multiple tooth replacement ofmandibular incisors, or3) for denture stabilization usingmultiple implants in the anteriormandible and maxilla.The implants may be placed inimmediate function when goodprimary stability has beenachieved and with appropriateocclusal loading. | in order to restore the patient'schewing function.The IS-III active System_S-narrow Type is indicated also forimmediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. | |
| SE Discussion | The ZENEX Implant System_Narrow has similar device characteristics with the Primary predicate, K161244 such as intended use,functions, material, surface treatment, fixture diameter, structure and applied production method.The difference between the subject device and primary predicate are device design, 15mm length fixtures, Ø3.2X8.5mm and shelf life.The difference of the device design of both device's fundamental functions and safety. To support the 15mmlength for each diameter, K220079 and K190849 were added as reference device. To support the difference of the Ø3.2X8.5mm andshelf life, the K190849 was added.Any differences do not raise different questions of safety and effectiveness than the primary predicate; therefore, it is substantialequivalent. |
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Abutment
1) Cover Screw
| Subject Device | Reference Device | ||
|---|---|---|---|
| Manufacturer | Izenimplant Co.,Ltd | Izenimplant Co.,Ltd | |
| Product Name | ZENEX Implant System_Narrow | ZENEX Implant System | |
| 510(K) Number | K230630 | K211090 | |
| Classification | Class II | Class II | |
| Design | Image: Subject Device Design | Image: Reference Device Design | |
| D | $Φ2.6~3.2$ | $Φ3.0~3.9$ | |
| Dimension | L | 4~6.1mm | 5~7.3mm |
| Angle | 0° | 0° | |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | |
| Surface | Non-Coating | Non-Coating | |
| Sterilization | Radiation | Radiation | |
| Shelf life | 5 years | 5 years | |
| SE Discussion | The subject device is similar in intended use, fundamental scientific technology, principleof operation, general design, technology, functions, and materials with the identifiedreference device, K211090.The difference between the subject and reference device is dimension of the device.However, it does not affect device's fundamental functions and safety; therefore, it issubstantial equivalent. |
2) Healing Abutment
| Subject Device | Reference Device | Reference Device | ||
|---|---|---|---|---|
| Manufacturer | Izenimplant Co.,Ltd | Izenimplant Co.,Ltd | Osstem Implant Co., Ltd | |
| Product Name | ZENEX ImplantSystem_Narrow | ZENEX Implant System | Osstem Implant System | |
| 510(K) Number | K230630 | K211090 | K161604 | |
| Classification | Class II | Class II | Class II | |
| Design | ||||
| Dimension | D | Φ4.0 | Φ4.3~9.0 | Φ4.0 |
| P/H | 3.0~9.0mm | 2.0~9.0mm | 3.0~9.0mm | |
| Angle | 0° | 0° | 0° | |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | |
| Surface | Non-Coating | Non-Coating | TiN Coating | |
| Sterilization | Radiation | Radiation | Radiation | |
| Shelf life | 5 years | 5 years | 5 years | |
| SE Discussion | The subject device is similar in intended use, fundamental scientific technology, principle of operation, general design, technology, functions, and materials with the identified reference device, K161604. | |||
| The difference between the subject and reference device, K161604 is surface treatment. To support the discrepancy, K211090 was added. Therefore, it is substantial equivalent |
{9}------------------------------------------------
3) Cemented Abutment
| Subject Device | Reference Device | ||
|---|---|---|---|
| Manufacturer | Izenimplant Co.,Ltd | Neobiotech Co., Ltd | |
| Product Name | ZENEX Implant System_Narrow | IS-III active System_S-Narrow Type | |
| Abutment Name | Cemented Abutment | IS Shapable Abutment | |
| 510(K) Number | K230630 | K190849 | |
| Classification | Class II | Class II | |
| Design | Image: Hex design of subject deviceImage: Non-Hex design of subject device | Image: Hex design of reference deviceImage: Non-Hex design of reference device | |
| Dimension | D | $Φ4.0$ | $Φ3.5/4.0$ |
| G/H | 2.0-5.0mm | 2.0-5.0mm | |
| P/H | 5.5/7.0mm | 5.5/7.0mm | |
| Angle | 0° | 0° | |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | |
| Surface | Partial TiN coated in upper | Partial TiN coated in upper | |
| Sterilization | End User Sterilization | End User Sterilization | |
| SE Discussion | The subject device is similar in intended use, fundamental scientific technology, principle of operation, general design, technology, functions, dimension and materials with the identified reference device, K190849.The design of the subject and reference device is slightly different. However, it does not affect device's fundamental functions and safety; therefore, it is substantial equivalent. |
4) Angled Abutment
| Subject Device | Reference Device | ||||
|---|---|---|---|---|---|
| Manufacturer | Izenimplant Co.,Ltd | DIO Corporation | |||
| Product Name | ZENEX Implant System_Narrow | UV Active Implant System | |||
| 510(K) Number | K230630 | K182194 | |||
| Classification | Class II | Class II | |||
| Design | |||||
| Hex | Non-Hex | Hex | Non-Hex | ||
| Dimension | D | Ф4.0 | Ф4.0/4.5/5.5 | ||
| G/H | 2.0/4.0mm | 1.5/2.0/3.0/4.0/5.0 | |||
| Angle | 15° | Ф4.0 - 15 °Ф4.5 - 15, 25 °Ф5.5 - 15, 25 ° | |||
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | |||
| Surface | Partial TiN coated in upper | Partial TiN coated in upper | |||
| Sterilization | End User Sterilization | End User Sterilization | |||
| SE Discussion | The subject device is similar in intended use, fundamental scientific technology,principle of operation, general design, technology, functions, and materials with theidentified reference device, K182194. The difference between the subject device andK182194 is design and dimensions.The design of the subject and reference device is slightly different, and it does notaffect device's fundamental functions and safety. The dimension of the subject deviceis in range of the dimension of the predicate. Therefore, it is substantial equivalent. |
{10}------------------------------------------------
| Subject Device | Reference Device | Reference Device | |||||
|---|---|---|---|---|---|---|---|
| Manufacturer | Izenimplant Co.,Ltd | DIO Corporation | J DENTALCARE®S.R.L. | ||||
| Product Name | ZENEX ImplantSystem_Narrow | UV Active Implant System | JDIcon® Implant System | ||||
| Abutment Name | FreeMilling Abutment | Mill abutment | GP Abutment | ||||
| 510(K) Number | K230630 | K182194 | K182081 | ||||
| Classification | Class II | Class II | Class II | ||||
| Design | Image: abutment | Image: abutment | Image: abutment | ||||
| Hex | Non-Hex | Hex | Non-Hex | Hex | Non-Hex | ||
| Hand Milling Only | Yes | Yes | Yes | ||||
| D | $ Φ 4.0 $ | $ Φ 3.2 / 4.0 $ | $ Φ 3.2 / 4.0 $ | ||||
| Dimension | G/H | 2.0/4.0mm | 1.5mm | 1.5mm | |||
| Angle | 0° | 0° | 0° | ||||
| Material | Ti-6Al-4V ELI | Titanium Grade4 | Ti-6Al-4V ELI | ||||
| Surface | Partial TiN coated in upper | Partial TiN coated in upper | No Coating | ||||
| Sterilization | End User Sterilization | ||||||
| SE Discussion | The subject device is similar in intended use, fundamental scientific technology, principleof operation, general design, technology, functions with the identified reference device,K182194.The difference between the subject device and K182194 is design, dimensions andmaterials. To support this material difference, K182081 was added.The design of the subject and reference device is slightly different, and it does not affectdevice's fundamental functions and safety. The dimension of the subject device is in rangeof the dimension of the predicate. Therefore, it is substantial equivalent. |
5) FreeMilling Abutment
6) CCM Cast Abutment
| Subject Device | Primary Predicate | ||
|---|---|---|---|
| Manufacturer | Izenimplant Co.,Ltd | Dentis Co.,Ltd | |
| Product Name | ZENEX Implant System_Narrow | s-Clean One-Q-SL Narrow Implant System | |
| 510(K) Number | K230630 | K161244 | |
| Classification | Class II | Class II | |
| Design | Image: red implant with hex | Image: silver implant with hex | |
| Hex | Hex | ||
| Image: silver implant without hex | Image: gray implant without hex | ||
| Non-Hex | Non-Hex | ||
| D | $Φ4.0$ | $Φ4.0$ | |
| Dimension | Length | 12.5/13/14.5/15mm | 14.5/15mm |
| Angle | 0° | 0° | |
| Material | Co-Cr-Mo Alloy | Co-Cr-Mo Alloy | |
| Surface | No Coating | No Coating | |
| Sterilization | End User Sterilization | End User Sterilization | |
| SE Discussion | The subject device is similar in intended use, fundamental scientific technology, principle of operation, general design, technology, functions, diameter and materials with the primary predicate, K161244. The difference between the subject device and predicate is lengths. Since it is the case abutment, the different length does not affect device's fundamental functions and safety. Therefore, it is substantial equivalent. |
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7) Temporary Abutment
| Subject Device | Reference Device | ||
|---|---|---|---|
| Manufacturer | Izenimplant Co.,Ltd | TruAbutment Korea Co.,Ltd | |
| Product Name | ZENEX Implant System_Narrow | URIS OMNI System | |
| 510(K) Number | K230630 | K172100 | |
| Classification | Class II | Class II | |
| Design | Image: Subject Device Design Hex | Image: Reference Device Design | |
| Hex | |||
| Non-Hex | |||
| Dimension | D | $Φ4.0$ | $Φ3.7/ Φ4.3mm$ |
| P/H | 10.0mm | 10.0mm | |
| Angle | 0° | 0° | |
| Maximum duration | Placed less than six months and out ofocclusion | Placed less than six months and out ofocclusion | |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | |
| Surface | No Coating | No Coating | |
| Sterilization | End User Sterilization | End User Sterilization | |
| SE Discussion | The subject device is similar in intended use, fundamental scientific technology,principle of operation, general design, technology, functions, and materials with theidentified reference device, K172100.The design of the subject and reference device is slightly different, and it does notaffect device's fundamental functions and safety. The dimension of the subject deviceis in range of the dimension of the predicate. Therefore, it is substantial equivalent. |
8) Abutment Screw
| Subject Device | Reference Device | ||
|---|---|---|---|
| Manufacturer | Izenimplant Co.,Ltd | Neobiotech Co., Ltd | |
| Product Name | ZENEX Implant System_Narrow | IS-III active System_S-NarrowType | |
| 510(K) Number | K230630 | K190849 | |
| Classification | Class II | Class II | |
| Design | Image: Subject Device Design | Image: Reference Device Design | |
| D | $Φ2.0$ | $Φ2.0$ | |
| Dimension | Length | 8.9mm | 10.2mm |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | |
| Surface | No Coating | No Coating | |
| Sterilization | End User Sterilization | End User Sterilization | |
| SE Discussion | The subject device is similar in intended use, fundamental scientifictechnology, principle of operation, general design, technology, functions,diameter, and materials with the identified reference device.The difference between the subject and reference device is length of thedevice. However, it does not affect device's fundamental functions andsafety; therefore, it is substantial equivalent. |
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Non-Clinical Data:
Below tests were performed on subject device:
- Bacterial Endotoxin Testing on Fixture according to USP <85> .
- . Fatigue Testing under the worst-case scenario according to ISO 14801:2016
Below tests were performed for predicate devices and leveraged for the subject device:
- Sterilization Validation Testing for Healing Abutment provided sterile according to ISO 11137-1 and ISO 11137-2 referenced in K211090
- Shelf-Life Testing on Fixture and Healing Abutment according to ASTM F1980 referenced in K211090
- End User Sterilization Validation Testing for Ti-6A1-4V ELI and CCM material according to ● ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K211090
- . Biocompatibility testing on abutments according to ISO 10993-1:2018 referenced in K211090
The surface modification information with SLA (sand-blasted, large-grit, acid-etched) was provided. To compare surface modification between the subject and predicate device. K211090, surface roughness, surface composition analysis, and SEM imaging were provided, and it demonstrate the substantial equivalence.
In accordance with the Association for the AAMI ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72), validation cycle of endotoxin will be processed and managed.
The Fatigue Testing was performed under the worst-case scenario according to ISO 14801:2016.
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the ZENEX Implant System_Narrow 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 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.
Clinical testing was not necessary to establish substantial equivalency of the device.
Conclusion
The ZENEX Implant System Narrow constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, ZENEX Implant System Narrow and its 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.