(86 days)
No
The 510(k) summary describes a dental abutment, a physical component used in dental implants. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The testing described is focused on biocompatibility, sterilization, and MRI compatibility, which are standard for physical medical devices.
No.
This device is an abutment for dental implants, used to support prosthetic restorations. Its function is primarily mechanical support, not therapeutic treatment of a disease or condition.
No
The document describes a dental abutment, which is a component used to support prosthetic restorations on a dental implant. Its intended use is structural support, not diagnosis.
No
The device description clearly details physical components made of Ti-6Al-4V ELI and Co-Cr-Mo, along with their dimensions and materials. The performance studies also include testing on these physical components (biocompatibility, sterilization, MRI review). This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures." This describes a device used in vivo (within the body) to support dental prosthetics.
- Device Description: The description details the physical components, dimensions, materials, and connection methods of dental abutments, which are physical components used in dental procedures.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
- Anatomical Site: The anatomical site is listed as "Dental," which aligns with a device used in the mouth for dental procedures, not for laboratory testing of biological samples.
The information provided describes a dental prosthetic component, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ZENEX FreeMilling & CCM Cast Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
ZENEX FreeMilling & CCM Cast Abutment consists of FreeMilling Abutment and CCM Cast Abutment.
ZENEX FreeMilling & CCM Cast Abutment is compatible with the fixtures below:
| K number | Device Name | Dimension Ranges |
|---|---|---|
| K211090 | ZENEX Implant System | |
| (ZENEX MULTI&PLUS Fixture) | Ø 3.75 x 8.5, 10, 11.5, 13, 15 | |
| Ø 4.25 x 7, 8.5, 10, 11.5, 13, 15 | ||
| Ø 4.6 x 7, 8.5, 10, 11.5, 13, 15 | ||
| Ø 5.05 x 7, 8.5, 10, 11.5, 13, 15 | ||
| Ø 5.4 x 7, 8.5, 10, 11.5, 13 | ||
| Ø 5.9 x 7, 8.5, 10, 11.5, 13 | ||
| Ø 6.75 x 7, 8.5, 10, 11.5, 13 |
Tolerance of dimension shall be within ± 1% range.
The dimensions of abutments are as following:
| Device Name | Dimension Ranges | Gingival Heights (mm) | Minimum Post height (mm) | Angulation |
|---|---|---|---|---|
| FreeMilling Abutment | Ø 4.0/4.5/5.0/5.2/5.7/6.0/6.5/7.0 | 1.3/1.8/2.8/3.8 | 4 | 0° |
| CCM Cast Abutment | Ø 4.0 / 4.5 | 0.8 / 2.8 | 4 | 0° |
The Abutments have below featured:
| Name | Uses | Surface | Connection |
|---|---|---|---|
| FreeMilling Abutment | The Abutment is connected with fixture, and it supports prosthesis which restores tooth function. | Partial TiN coated in upper | Screw retained |
| CCM Cast Abutment | It is an abutment that is used when making a retained / customized prosthesis. | NA | Screw retained |
Tolerance of dimensions for Abutments shall be within ± 1% range.
ZENEX FreeMilling & CCM Cast Abutment is provided non-sterile.
Materials:
- FreeMilling Abutment is fabricated of Ti-6Al-4V ELI according to ASTM F136-13
- CCM Cast Abutment is fabricated of Co-Cr-Mo according to ASTM F1537-11
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental implant
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Data:
- Biocompatibility Testing on subject CCM Cast Abutment according to ISO 10993-1:2020
- End User Sterilization Validation Test Report on subject CCM Cast Abutments according to ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1.
- End User Sterilization Validation Test Report for Abutments made with Ti-6Al-4V ELI according to ANSI/AAMI ST79. ISO 17665-1.-2. ISO 11737-1.-2. and ISO 11138-1 referenced in K211090
- Biocompatibility testing for Abutments made with Ti-6Al-4V ELI according to ISO 10993-1:2009 referenced in K211090
Key Results: The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device. The end user sterilization validation is performed on the subject CCM Cast Abutment according to ISO 17665-1 and ISO 17665-2. The worst-case construct was tested, and results demonstrated equivalence to the predicate device. Biocompatibility Testing was performed according to ISO 10993-1:2009 and the FDA Guidance document, demonstrating that the subject device is biocompatible and substantial equivalence with the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
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Image /page/0/Picture/0 description: The image contains 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Izenimplant Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K231557
Trade/Device Name: ZENEX FreeMilling & CCM Cast Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 30, 2023 Received: May 30, 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
ZENEX FreeMilling & CCM Cast Abutment
Indications for Use (Describe)
The ZENEX FreeMilling & CCM Cast Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
| Type of Use (Select one or both, as applicable) |
|---|
| For Therapeutic Use Only (OTC, NDA, or Rx) |
| For The Cosmetic Use Only (OTC, NDA, or Rx) |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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 FreeMilling & CCM Cast Abutment
- Common Name: Dental Implant Abutment ●
- . Classification Name: Abutment, Implant, Dental, Endosseous
- . Product Code: NHA
- Panel: Dental
- Regulation Number: 872.3630
- Device Class: Class II
- Date Prepared: 08/24/2023
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- . K161689, OSSTEM Implant System - Abutment by Osstem Implant Co., Ltd.
Reference devices
- K192263, UCLA CCM Abutment by DIO Corporation ●
- K211090, ZENEX Implant System by Izenimplant Co., Ltd.
Indication for Use:
The ZENEX FreeMilling & CCM Cast Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
4
Device Description:
ZENEX FreeMilling & CCM Cast Abutment consists of FreeMilling Abutment and CCM Cast Abutment.
ZENEX FreeMilling & CCM Cast Abutment is compatible with the fixtures below:
| K number | Device Name | Dimension Ranges |
|---|---|---|
| K211090 | ZENEX Implant System | |
| (ZENEX MULTI&PLUS Fixture) | $Ø$ 3.75 x 8.5, 10, 11.5, 13, 15 | |
| $Ø$ 4.25 x 7, 8.5, 10, 11.5, 13, 15 | ||
| $Ø$ 4.6 x 7, 8.5, 10, 11.5, 13, 15 | ||
| $Ø$ 5.05 x 7, 8.5, 10, 11.5, 13, 15 | ||
| $Ø$ 5.4 x 7, 8.5, 10, 11.5, 13 | ||
| $Ø$ 5.9 x 7, 8.5, 10, 11.5, 13 | ||
| $Ø$ 6.75 x 7, 8.5, 10, 11.5, 13 |
Tolerance of dimension shall be within ± 1% range.
The dimensions of abutments are as following:
| Device Name | Dimension Ranges | Gingival
Heights (mm) | Minimum Post
height (mm) | Angulation |
|-------------------------|---------------------------------------|--------------------------|-----------------------------|------------|
| FreeMilling
Abutment | Ø 4.0/4.5/5.0/5.2/5.7/
6.0/6.5/7.0 | 1.3/1.8/2.8/3.8 | 4 | 0° |
| CCM Cast Abutment | Ø 4.0 / 4.5 | 0.8 / 2.8 | 4 | 0° |
The Abutments have below featured:
| Name | Uses | Surface | Connection |
|---|---|---|---|
| FreeMilling | |||
| Abutment | The Abutment is connected with fixture, and it | ||
| supports prosthesis which restores tooth function. | Partial TiN | ||
| coated in | |||
| upper | Screw | ||
| retained | |||
| CCM Cast Abutment | It is an abutment that is used when making a retained | ||
| / customized prosthesis. | NA | Screw | |
| retained |
Tolerance of dimensions for Abutments shall be within ± 1% range.
ZENEX FreeMilling & CCM Cast Abutment is provided non-sterile.
Materials:
- FreeMilling Abutment is fabricated of Ti-6Al-4V ELI according to ASTM F136-13 ●
- . CCM Cast Abutment is fabricated of Co-Cr-Mo according to ASTM F1537-11
5
Summaries of Technological Characteristics & Substantial Equivalence Discussion
FreeMilling Abutment
| Subject Device | Primary Predicate | ||||||
|---|---|---|---|---|---|---|---|
| Manufacturer | Izenimplant Co.,Ltd | Manufacturer | OSSTEM Implant Co., Ltd. | ||||
| Product Name | ZENEX FreeMilling & CCM Cast | ||||||
| Abutment | Product Name | OSSTEM Implant System - Abutment | |||||
| Model Name | FreeMilling Abutment | Model Name | FreeForm ST Abutment | ||||
| 510(K) Number | K231557 | 510(K) Number | K161689 | ||||
| Indications for Use | The ZENEX FreeMilling & CCM Cast | ||||||
| Abutment is intended for use with a dental | |||||||
| implant to provide support for prosthetic | |||||||
| restorations such as crowns, bridges, or | |||||||
| overdentures. | Indications for Use | The OSSTEM Implant System - Abutment | |||||
| is intended for use with a dental implant to | |||||||
| provide support for prosthetic restorations | |||||||
| such as crowns, bridges, or overdenture | |||||||
| Design | Image: Hex | ||||||
| Image: Non-Hex | Design | Image: Hex | |||||
| Image: Non-Hex | |||||||
| Hand Milling Only | Yes | Hand Milling Only | Yes | ||||
| Dimension | D | ||||||
| G/H | |||||||
| P/H | |||||||
| Angle | Dimension | 4.0/4.5/5.0/5.2/5.7/6.0/6.5/7.0 | |||||
| 1.3/1.8/2.8/3.8 | |||||||
| 8 / 9mm | |||||||
| 0° | Dimension | D | |||||
| G/H | |||||||
| P/H | |||||||
| Angle | Dimension | $Φ$ 4.0/5.0/5.5/6.0/7.0 | |||||
| 1.5 / 3.5 | |||||||
| 9/10.5mm | |||||||
| 0° | |||||||
| Material | Ti-6Al-4V ELI | Material | Ti-6Al-4V ELI | ||||
| Surface | Partial TiN coated in upper | Surface | Partial TiN coated in upper | ||||
| Sterilization | End User Sterilization | Sterilization | End User Sterilization | ||||
| SE Discussion | The Subject Device and Primary Predicate (K161689) have same indications for use, | ||||||
| diameters, material, and sterilization method. The differences between two devices are | |||||||
| gingival height and post height, however, the values are very similar and these differences | |||||||
| are not important factor for the device performance. Both devices are substantial | |||||||
| equivalent. |
CCM Cast Abutment
| Subject Device | Reference Device | ||||
|---|---|---|---|---|---|
| Manufacturer | Izenimplant Co.,Ltd | DIO Corporation | |||
| Product Name | ZENEX FreeMilling & CCM Cast Abutment | UCLA CCM Abutment | |||
| Model Name | CCM Cast Abutment | UCLA CCM Abutment | |||
| 510(K) Number | K231557 | K192263 | |||
| Design | Image: red abutment | Image: white abutment | Image: red abutment | Image: white abutment | |
| Hex | Non-Hex | Hex | Non-Hex | ||
| Dimension | D | 4.0 / 4.5 | 4.0/4.5 | ||
| G/H | 0.8 / 2.8 | 1.0/3.0 | |||
| P/H | 10.0 | 10.0 | |||
| Angle | 0° | 0° | |||
| Material | CCM Abutment | ||||
| Plastic Sleeve | CoCrMo Alloy | ||||
| POM | CCM Abutment | ||||
| Plastic Sleeve | CoCrMo Alloys | ||||
| POM | |||||
| Surface | Non-Coating | Non-Coating | |||
| Sterilization | Steam Sterilization by user | ||||
| (Delivered non sterile) | Steam Sterilization by user | ||||
| (Delivered non sterile) |
6
| SE Discussion | The Subject Device and Reference Device (K192263) have same indications for use, diameters, material, and sterilization method. The differences between two devices are gingival height and post height, however, the values are very similar, and these differences are not important factor for the device performance. Both devices are substantial equivalent. |
|---|---|
| --------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Non-Clinical Test Data
Below tests were performed on subject device:
- Biocompatibility Testing on subject CCM Cast Abutment according to ISO 10993-1:2020 ●
- End User Sterilization Validation Test Report on subject CCM Cast Abutments according to ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1
Below tests were performed for predicate devices and leveraged for the subject device:
- . End User Sterilization Validation Test Report for Abutments made with Ti-6Al-4V ELI according to ANSI/AAMI ST79. ISO 17665-1.-2. ISO 11737-1.-2. and ISO 11138-1 referenced in K211090
- Biocompatibility testing for Abutments made with Ti-6Al-4V ELI according to ISO 10993-1:2009 referenced in K211090
The surface modification information of TiN Coating such as chemical composition, coating thickness, abrasion characteristics, and SEM imaging provided in the previous cleared device, K211090 can be leveraged for the subject FreeMilling abutment.
The end user sterilization test was performed for predicate device, K211090 and leveraged for the subject device made with Ti-6A1-4V ELI because the product material, manufacturing process, sterilization methods and packaging of both products are exactly same.
The end user sterilization validation is performed on the subject CCM Cast Abutment according to ISO 17665-1 and ISO 17665-2. The worst-case construct was tested, and results demonstrated equivalence to the predicate device.
The Biocompatibility Test was conducted on the predicate device, K211090 and leveraged for the subject device made with Ti-6Al-4V ELI because both products are manufactured with same materials and manufacturing process. It demonstrates that the subject device is biocompatible and substantial equivalence with the predicate.
Biocompatibility Testing was performed according to ISO 10993-1:2009, "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: June 16, 2016", for subject CCM Cast Abutments
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic. Dentis I-FIX Abutment in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., 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 bodied, 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.
7
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Conclusion
ZENEX FreeMilling & CCM Cast Abutment 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 FreeMilling & CCM Cast Abutment and its predicates are substantially equivalent.