Ti Link Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

All digitally designed abutments for use with Ti Link Abutment are intended to be manufactured at a Izenimplant validated milling center.

Device Description

The Ti Link Abutment is a two-piece abutment intended to provide support for restorations such as crowns and bridges. The two pieces which compose the final abutment consist of the pre-manufactured titanium base component composed of titanium alloy conforming to ASTM F136, and the CAD/CAM patient matched mesostructure composed of zirconia (K091096). The diameters of the premanufactured titanium base component are 4.0/4.5mm. The final two-piece abutment is fixed to the implant with an abutment screw composed of titanium alloy conforming to ASTM F136. Ti Link Abutment is provided non-sterile, therefore must be sterilized after the cementation of the CAD/CAM patient matched mesostructure on the pre-manufactured titanium base component.

The abutments are compatible with the implants cleared under K211090.

The CAD/CAM patient matched mesostructure that is added to the pre-manufactured titanium base component to create the final abutment design should be designed and milled through the CAD/CAM software, according to the prosthetic planning and patient clinical situation. The coping and crowns designed using these or more recent versions of the CAD/CAM System, within the design limits as defined within the design software, are compatible with the Ti Link Abutment. The coping would be manufactured by Izenimplant only with design input using CAD/CAM Software from and by Izenimplant milling center.

CAD/CAM patient matched mesostructure is made from NaturaZ (K091096) and is cemented to the pre-manufactured titanium base component using RelyX cement (K110508) to complete the final finished abutment.

AI/ML Overview

This document, a 510(k) Premarket Notification from the FDA, concerns the "Ti Link Abutment" device, an endosseous dental implant abutment. It aims to demonstrate the device's substantial equivalence to previously cleared predicate devices.

Crucially, this document does NOT describe the acceptance criteria and study proving a device meets those criteria for software or AI-based medical devices. This is a hardware dental implant abutment, and the "testing" performed is for mechanical and biocompatibility properties, not algorithmic performance.

Therefore, many of the requested points related to AI/software study design (sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this specific FDA submission document.

However, I can extract and present the information that is relevant to the document regarding the device's acceptance criteria and the studies performed:

Acceptance Criteria and Study for Ti Link Abutment (Hardware Device)

Since this is a hardware device (dental implant abutment) and not an AI/software device, the concept of "acceptance criteria" and "performance" is based on mechanical, material, and biocompatibility standards rather than algorithmic metrics like accuracy, sensitivity, or specificity.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion / Test Type	Description / Standard	Acceptance Criteria	Reported Device Performance / Outcome
Fatigue Test	According to ISO 14801:2016 under worst-case scenario (two occurrences)	Meets requirements of ISO 14801:2016	"The results of the above tests have met the criteria of the standard"
End User Steam Sterilization	According to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010	Meets requirements of ISO 17665 and ANSI/AAMI ST79	"The results of the above tests have met the criteria of the standard"
Cytotoxicity Testing	According to ISO 10993-5:2009	Meets requirements of ISO 10993-5:2009	"The results of the above tests have met the criteria of the standard"
Biocompatibility Tests	According to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010 (leveraged from predicate K211090)	Meets requirements of ISO 10993 series	"Biocompatibility test data was used to evaluate the proposed device's substantial equivalence... The results... have met the criteria of the standard"
Material Composition	Ti-6Al-4V ELI (ASTM F136) for titanium base, Zirconia Oxide for mesostructure	Conforms to specified ASTM and Zirconia standards	Stated as conforming to ASTM F136 (Ti-6Al-4V ELI) and using Zirconia (K091096).
Design Parameters	Angulation, cuff height, thickness, abutment post length	Within specified design limits (e.g., 0-15° angulation)	Explicitly stated design limits. Implicitly met.
Magnetic Resonance (MR) Safety	Evaluation performed based on scientific rationale and published literature	Compatible with MR environment	"Non-clinical worst-case MRI review was performed... rationale addressed parameters per the FDA guidance." (Implies deemed safe)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated in terms of number of manufactured units tested for the fatigue, sterilization, and cytotoxicity tests. These types of tests typically follow specific ISO/ASTM standards that dictate sample sizes based on statistical methods or industry practice, but the exact numbers are not detailed in this summary.
Data Provenance: The tests were conducted for the subject device. Biocompatibility test data was "leveraged" from a predicate device (K211090), which is owned by the applicant. This implies in-house or contracted lab testing for the subject device-specific tests, and prior testing data for the predicate. No information about country of origin for the data is provided, but it's likely originating from the manufacturer's region (Republic of Korea, as per submitter address) or contract laboratories they engaged.
Retrospective/Prospective: The testing described (Fatigue, Sterilization, Cytotoxicity, Biocompatibility) are prospective tests specifically conducted to support this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. This document pertains to the physical and material properties of a dental device, not an AI or software device requiring human expert annotation for ground truth. Ground truth for these tests is established by objective measurements against engineering standards (e.g., force applied, temperature, cell viability, chemical composition).

4. Adjudication Method for the Test Set:

Not Applicable. As there are no human expert reviewers establishing observational data, there is no need for an adjudication method. Test results are typically objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is relevant to AI/software performance with human users. It is not applicable to a hardware dental abutment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a hardware device; there is no standalone algorithm to evaluate.

7. The Type of Ground Truth Used:

For mechanical, sterilization, and cytotoxicity tests: The ground truth is defined by the acceptance criteria of the relevant ISO, ASTM, and ANSI/AAMI standards. For example, the fatigue test ground truth is whether the device withstands a specified number of cycles at a specific load without failure, as per ISO 14801. Cytotoxicity is measured against living cell responses.
For material composition: Ground truth is established by material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI).
For biocompatibility: Ground truth is established by the safety profiles defined in the ISO 10993 series for medical device biological evaluation.

8. The Sample Size for the Training Set:

Not Applicable. This is a hardware device; there is no AI/ML model with a "training set." The CAD/CAM design process does not involve machine learning in this context; it refers to computer-aided design and manufacturing.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. No training set exists for this hardware device.

Summary

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January 12, 2024

Izenimplant Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K232170

Trade/Device Name: Ti Link Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 14, 2023 Received: December 14, 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 (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 (OS) 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.

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.

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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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K232170

Device Name

Ti Link Abutment

Indications for Use (Describe)

Ti Link Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

All digitally designed abutments for use with Ti Link Abutment are intended to be manufactured at a Izenimplant validated milling center.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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

Device Information

Trade Name: Ti Link Abutment
Common Name: Endosseous dental implant abutment
. Classification Name: Abutment, Implant, Dental, Endosseous
Product Code: NHA
. Panel: Dental
. Regulation Number: 21 CFR 872.3630
Device Class: Class II
Date prepared: 01/11/2024

Predicate Devices:

The subject device is substantially equivalent to the following predicate device:

Primary Predicate

K181037, DIO CAD/CAM Abutment by DIO Corporation
Reference Predicate
K211090, ZENEX Implant System by Izenimplant Co., Ltd. ●
K091096, NATURAZ SERIES, MODEL B16, B20, B42, B60, B98, B100 by DENTAL ● SOLUTIONS, INC.
K110508, 3M RelyX Ultimate Cement by 3M ESPE ●

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

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Device Description

The abutments are compatible with the implants cleared under K211090.

Proprietary Name	ZENEX Multi Fixture	ZENEX Plus Fixture
Compatible Implants(K number)	K211090
Implant diameter size	Ø 3.75, 4.25, 4.6, 5.05, 5.4, 5.9, 6.75
Implant Interface ConnectionType/Size(mm)	I-System: Internal connection type/3.2 (Mini), 3.35 (Regular/Wide)T-System: Internal connection type/2.8 (Mini), 3.35 (Regular/Wide)
Type of Implant-AbutmentConnection	Hex/Non-Hex

Raw material blanks

. K091096, NATURAZ SERIES, MODEL B16, B20, B42, B60, B98, B100 by DENTAL SOLUTIONS, INC.
Raw material cement
K110508, 3M RelyX Ultimate Cement by 3M ESPE ●
The CAD/CAM patient matched mesostructure that is added to the pre-manufactured titanium base component to create the final abutment design should be designed and milled through the CAD/CAM software, according to the prosthetic planning and patient clinical situation. The coping and crowns designed using these or more recent versions of the CAD/CAM System, within the design limits as defined within the design software, are compatible with the Ti Link Abutment. The coping would be manufactured by Izenimplant only with design input using CAD/CAM Software from and by Izenimplant milling center.

Design Parameter	Design Limit
Minimum and Maximum angulation (°)	0-15
Minimum and Maximum cuff height (mm)	0-5.0
Minimum thickness (mm)	0.55
Minimum and Maximum length of abutment post (lengthabove the abutment collar / gingival height) (mm)	4.0-4.5

Design Limitation for CAD/CAM patient matched mesostructure:

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Indication for Use

Ti Link Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

All digitally designed abutments for use with Ti Link Abutment are intended to be manufactured at a Izenimplant validated milling center.

Summaries of Technological Characteristics

The subject device is substantially equivalent to the currently cleared devices. They are substantially equivalent in intended use, material and connection interfaces to the implants are identical for each individual diameter and connection type. Comparison demonstrating Substantial Equivalence follows:

	Subject Device	Primary Predicate Device
Applicant	Izenimplant Co., Ltd.	DIO Corporation
Trade Name	Ti Link Abutment	DIO CAD/CAM Abutment
510(K) No.	NA	K181037
ClassificationName	Endosseous Dental Implant, Abutment(872.3630)	Endosseous Dental Implant, Abutment(872.3630)
Product Code	NHA	NHA
Class	II	II
Material	- Ti-6Al-4V ELI (ASTM F136): Pre-manufactured titanium base component- Zirconia Oxide: CAD/CAM patientmatched mesostructure component	Ti-6Al-4V ELI (ASTM F136)Zirconia Oxide
Titanium basecomponentrepresentativeimage	Image: Titanium base component representative image	Image: Titanium base component representative image
Diameters (mm)	4.0/4.5	4.0/4.5/5.5
MesostructureAngulation (°)	0-15	0-15
Mesostructurematerial	Zirconia (K091096)	Zirconia
Sterile	Steam Sterilization by user(Delivered non sterile)	Steam Sterilization by user(Delivered non sterile)
Type of Retention	Screw-retained to the implant. Theprosthesis can be cement retained to theabutment.	Screw-retained to the implant. The prosthesis can be cementretained to the abutment.
Coating	Non-Coating	Non-Coating
Indications ForUse	Ti Link Abutment is intended for use withdental implants as a support for single ormultiple tooth prostheses in the maxilla ormandible of a partially or fully edentulouspatient.All digitally designed abutments for usewith Ti Link Abutment are intended to be	DIO CAD/CAM Abutment is intended for use with dentalimplants as a support for single or multiple tooth prosthesesin the maxilla or mandible of a partially or fully edentulouspatient.ImplantSystemCompatibilityImplantDiameter(mm)Platform Diameter(mm)

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	manufactured at a Izenimplant validatedmilling center.	UF(II)NarrowImplantSystem	3.0/3.3	3.0/3.3
		UF SubmergedImplantSystem	3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0	3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0
		UF(II)ImplantSystem	3.8/4.0/4.5/5.0/5.5	3.8/4.0/4.5/5.0/5.5
	Patient specific abutment is intended for use with the UF(II)Implant System. All digitally designed abutments for usewith DIO CAD/CAM Abutments are intended to bemanufactured at a DIO Corporation validated milling center.
	The subject Ti Link Abutment is substantially equivalent in designs, dimensions, material,indications, and technological characteristics with the identified primary predicate device. The TiLink Abutment is similar in fundamental scientific technology to the predicate device inthat they all have been designed, manufactured and tested in compliance with FDA's ClassII special controls guidance document root-food endosseous dental implants andendosseous dental implant abutments.
SubstantialEquivalenceComparison	The diameters of the subject device are slightly different from the predicate devices. However,the subject diameters are in the range of diameters of predicates and this dimensional differencedoesn't affect device safety and effectiveness.The Indications for Use of the subject and primary predicate device are identical other than thecompatible implant bodies. This difference is mitigated by fatigue testing and identification ofreference device for compatible implant bodies. Both the predicate and subject devices areintended to be milled into patient specific abutments using CAD/CAM technology under themanufacturing control of the sponsor.Any differences in technology characteristics are accompanied by information thatdemonstrated the device is substantially equivalent as the predicate and do not raisedifferent questions of safety and effectiveness than the predicate.

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Non-clinical Testing

The subject device was tested to evaluate its substantial equivalence according to the following standards.

. Fatigue Test according to ISO 14801:2016 under worst case scenario (two occurrences)
End User Steam Sterilization Tests according to ISO 17665-1:2006, 17665-2:2009 and ● ANSI/AAMI ST79:2010
Cytotoxicity testing according to ISO 10993-5:2009 ●

Below tests were performed for predicate devices, K211090 and leveraged for the subject device:

Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-● 10:2010.
Biocompatibility test data was used to evaluate the proposed device's substantial equivalence compared to the predicate device which is owned by the applicant. The results of the above tests have met the criteria of the standard and demonstrated the substantial equivalence with the predicate device.

Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario through fatigue testing.

MR Environment Condition

Non-clinical worst-case MRI review was performed to evaluate the Ti Link Abutment 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 Ti Link 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 device. Therefore, Ti Link Abutment and its predicates are substantially equivalent.

Regulation Number and Section

§ 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.)