(175 days)
No
The summary describes a dental abutment and its manufacturing process using CAD/CAM technology, which is a standard digital design and milling process, not AI/ML. There is no mention of AI, ML, or related concepts in the document.
No.
A therapeutic device is intended to treat or cure a disease or condition. This device is an abutment for dental implants, which supports prostheses in patients with missing teeth, but does not treat a disease.
No
Explanation: The device, Ti Link Abutment, is described as a two-piece abutment intended to provide support for restorations like crowns and bridges on dental implants. Its description focuses on its materials, manufacturing process, and compatibility with implants and CAD/CAM systems. There is no indication that it is used to diagnose any condition, disease, or provide diagnostic information.
No
The device description clearly outlines physical components made of titanium alloy and zirconia, which are hardware. While CAD/CAM software is mentioned for design, the final device is a physical abutment.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for supporting dental prostheses in the maxilla or mandible. This is a structural and mechanical function within the body.
- Device Description: The description details the physical components (titanium base, zirconia mesostructure, screw) and their materials. It describes how the device is assembled and used to support a restoration.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is implanted within the body to provide structural support.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
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)
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.
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.
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.)
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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.
1
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.
2
3
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
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
5
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.
| 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 Connection | ||
| Type/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-Abutment | ||
| Connection | 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.
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.
| 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 (length | |
| above the abutment collar / gingival height) (mm) | 4.0-4.5 |
Design Limitation for CAD/CAM patient matched mesostructure:
6
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 |
| Classification | ||
| Name | 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 patient
matched mesostructure component | Ti-6Al-4V ELI (ASTM F136)
Zirconia Oxide |
| Titanium base
component
representative
image | Image: Titanium base component representative image | Image: Titanium base component representative image |
| Diameters (mm) | 4.0/4.5 | 4.0/4.5/5.5 |
| Mesostructure
Angulation (°) | 0-15 | 0-15 |
| Mesostructure
material | 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. The
prosthesis can be cement retained to the
abutment. | Screw-retained to the implant. The prosthesis can be cement
retained to the abutment. |
| Coating | Non-Coating | Non-Coating |
| Indications 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 | DIO CAD/CAM 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.
Implant
System
Compatibility
Implant
Diameter
(mm)
Platform Diameter
(mm) |
7
| | manufactured at a Izenimplant validated
milling center. | UF(II)
Narrow
Implant
System | 3.0/3.3 | 3.0/3.3 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------------------------------|-----------------------------------------|
| | | UF Sub
merged
Implant
System | 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)
Implant
System | 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 use
with DIO CAD/CAM Abutments are intended to be
manufactured 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 Ti
Link Abutment is similar in fundamental scientific technology to the predicate device in
that they all have been designed, manufactured and tested in compliance with FDA's Class
II special controls guidance document root-food endosseous dental implants and
endosseous dental implant abutments. | | | |
| Substantial
Equivalence
Comparison | 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 difference
doesn't affect device safety and effectiveness.
The Indications for Use of the subject and primary predicate device are identical other than the
compatible implant bodies. This difference is mitigated by fatigue testing and identification of
reference device for compatible implant bodies. Both the predicate and subject devices are
intended to be milled into patient specific abutments using CAD/CAM technology under the
manufacturing control of the sponsor.
Any differences in technology characteristics are accompanied by information that
demonstrated the device is substantially equivalent as the predicate and do not raise
different questions of safety and effectiveness than the predicate. | | | |
8
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.